May 2008 Volume 10 , Supplement 1

The Official Peer-Reviewed Publication of the Consortium of Centers Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021

Abstracts from the 22nd Annual Meeting of the Consortium of Multiple Sclerosis Centers Comprehensive Approaches to Complex Challenges 28 –31 May 2008 Denver, CO, USA

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©2008 Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470 All rights reserved. 521-10-0004-08 Printed in USA. May 2008 Editorial Board EDITOR -IN -C HIEF Robert M. Herndon, MD Comprehensive Approaches to Director, Department of Neurology University of Mississippi Medical Center Jackson, Mississippi, USA EX OFFICIO Complex Challenges June Halper, MSN, ANP, FAAN Executive Director MS Comprehensive Care Center at Holy Name Hospital ince 1986, the Consortium of Multiple Sclerosis Centers Consortium of MS Centers IOMSN (CMSC) has convened an annual meeting that focuses on Teaneck, New Jersey, USA

treatment, research, care patterns, and breakthroughs in Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 ASSOCIATE EDITORS S Mark Freedman, MD MS. The leit motif of each meeting reflects the multidisciplinary Ottawa Hospital Ottawa, Quebec, Canada nature of our organization, incorporating the team approach over Susan J. Forwell, PhD, OT(C), FCAOT a person’s lifetime with the disease. Initially, the annual meeting University of British Columbia Vancouver, British Columbia, Canada featured didactic presentations and workshops, but gradually it Claudio Solaro, MD grew in attendance, opportunities for interaction, and submis - Micone Hospital Genoa, Italy sions for posters, platform presentations, and works in progress. Judy Wollin, RN, PhD Queensland University of Technology Brisbane, Australia 2008 has proved to be a banner year! Our program includes CONTROVERSIES EDITOR numerous members of CMSC, as well as many national and Dorothea Pfohl, RN University of Pennsylvania international MS thought leaders. In addition, our Education Health Systems Committee was gratified by the numerous high-quality submis - Philadelphia, Pennsylvania, USA CASE REPORTS EDITOR sions that focus on MS care, research, education, rehabilitation, Michael Kaufman, MD Carolinas HealthCare System and psychosocial support. These abstracts were judged by a Charlotte, North Carolina, USA committee of MS experts who were impressed by the depth of BOARD MEMBERS Kathleen Costello, MS, RN, MSCN information that will be presented in Denver from 28 to 31 Edgardo Cristiano, MD May 2008. Gary Fulcher, PhD Nancy Holland, RN, EdD, MSCN Rosalind Kalb, PhD Godelieve Nuyens, PhD, PT CMSC is extremely grateful to Bayer HealthCare Pharmaceuticals, Victor M. Rivera, MD Inc. for their support, which enabled our journal, the Inter nation al Amy Perrin Ross, APRN, MSN CNRN, MSCN Journal of MS Care , to provide our readers with the abstracts

PUBLISHER from the 2008 CMSC annual meeting. We are proud of all of Joseph J. D’Onofrio our partnerships and appreciate the ongoing recognition of the DELAWARE MEDIA GROUP 66 S. M APLE AVE ., R IDGEWOOD , NJ 07450 value of our work by the pharmaceutical industry. PHONE 201-612-7676 [email protected] MANAGING EDITOR We hope you will sustain your interest and dedication to the Orit Lowy Chicherio fight against multiple sclerosis and will provide us with your ART DIRECTOR James Ticchio input and expertise to sustain our growing organization.

Cop yright © 2008 by the Cons ort ium of Mul - tiple Sclerosis Centers and Rehabilitation in Multiple Sclerosis. All rights reserved. None of —June Halper, MSCN, ANP, FAAN the contents of this publication may be repro - duced without written permission of the pub - CMSC/IOMSN lisher. Statements and opinions in this publica - tion are solely those of the authors and contributors and not of the publisher, spon - sors, or Editorial Board. ISSN 1537-2073. Platforms

depression, a common comorbidity in MS, and falsely ele - Platforms vate depression scores. However, few studies have document - (P01) Recognition and Treatment of Comorbid ed this problem in the clinical assessment of depression in Mental Health Problems in People With Multiple MS. Design/Methods: A total of 557 adults with a diag - Sclerosis: 18-Month Evaluation of Nurse-Led nosis of MS were seen by Health Psychology for consecutive Mental Health Service evaluations including chart review, interview, and completion of the Beck Depression Inventory-II (BDI-II). Patients had a Background: Mental health and emotional problems are mean age of 42.6 years; were predominately women widespread within the multiple sclerosis (MS) population. (76.8%), white (81.1%), married (57%), educated (66.7% These needs are often undiagnosed and often lead to a with at least some college), and unemployed (50.7%); and reduction in quality of life. Objectives: To meet this unmet had relapsing-remitting MS (76.4%), with a mean of 5.7 need, a mental health nurse was appointed to a local MS years since diagnosis. Exploratory factor analyses (EFAs) service. The aim of this appointment was to assess and treat were conducted to test the validity of Beck’s 2-factor (cogni - mental health issues within the local MS population; work col -

tive-affective and somatic) model. Then, we compared overall Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 laboratively with mental health, neurology, and MS nurse depression scores, the percentage contribution of specific services; and provide education to local MS nurses with a items (energy, tiredness or , and sleep) to the total BDI- view to improving detection and treatment of mental health II score, and the sum contribution of the somatic factor issues. Methods: MS professionals provided initial screen - between patients who identified fatigue as their worst MS ing of MS patients with their clinical skills and Hospital and symptom and all other patients. Results: The BDI-II mean Anxiety and Depression Scale (HADS), and patients with total score was 20.8, with 29.8% endorsing minimal, 19.2% identified mental health difficulties were referred to the mental mild, 27.3% moderate, and 23.7% severe depression. EFA health nurse. All details of those referred, diagnoses, and revealed two factors (cognitive-affective and somatic) consis - treatment pathways were recorded. Results: At 18 months, tent with Beck’s model and previous work with non-MS popu - 115 people were referred into the project. Eighty-one lations. The 20.3% who identified fatigue as their worst MS received assessment, and 32 declined input. The mean num - symptom had comparable BDI-II scores, depression severity, ber of received sessions with the mental health nurse was and percentage contribution of the somatic factor. In the 4.79. Women made up 68.7% of referrals; the mean age of fatigue group, the only item with a significantly higher per - patients was 42.5 years. Of the patients referred, 63.2% had centage contribution was loss of energy ( P < .05, 9.5 vs relapsing-remitting MS, 16.7% had secondary MS, and 7.6%). Conclusion/Discussion: We conclude that somatic 15.8% had primary progressive MS. Of patients, 82.5% items do not necessarily confound depression scores for indi - were referred with depression, 48.5% were referred with viduals with MS and should be retained in the BDI-II. Addi - anxiety, and 43.8% presented with depression comorbid with tional implications and recommendations for clinical assess - anxiety. In addition, 34.5% were experiencing difficulties ment of depression in MS will be discussed. with cognition, and 5.3% were diagnosed with frontal lobe syndrome. Psychosis was present in 4.1% of this population, Peggy Crawford, PhD*; Noah Webster, MA; Farrah Thomas, PsyD whereas bipolar disorder presented in 5.2%. Suicidal *Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA ideation was also common in 33.7% of patients, of whom (P03) Comparison of Neuropsychological Test 12.4% ( n = 11) had formulated plans and 2% ( n = 1) had Findings and Driving Evaluation Performance in attempted suicide. Patients were offered various treatments Multiple Sclerosis Patients including medication (52.6%), and 40% were offered cogni - tive behavior therapy (CBT). Of those receiving CBT, HADS Background: With the comprehensive decline in physical, scores indicated a reduction in mood scores over the treat - cognitive, and behavioral functions that is often associated ment period. Conclusions: Mental health and emotional with the disease progression of multiple sclerosis (MS), a problems are common in people with MS. Detection and patient’s ability to operate a motor vehicle may be adversely treatment of mental health problems is vital to improving their affected, impacting level of independence or potential quality of life. Mental health nurses can assess and treat a employment. Objective: Identify the cognitive and physical spectrum of problems and provide a beneficial service to characteristics of MS patients who received clinical neuropsy - patients with MS working collaboratively with neurology and chological testing (NPT) and community-based behind-the- psychiatric services for multidisciplinary provision to patients. wheel (BTW) driving evaluations within 1 year, and compare Sally Askey-Jones, BNurs (Hons), RN*; Eli Silber, MD; Richard Gray, PhD, RN; the driving recommendations from both disciplines. Method: Anthony David, MD; Kevin Gournay, PhD, CPsychol, RN; Pauline Shaw, BSc, A chart review of MS patients referred for BTW driving evalu - RGN; Trudie Chalder, RN, MSc, PhD ations between 2001 and 2005 was performed. Of the 73 *Mental Health Nursing, David Goldberg Centre, Institute of Psychiatry, patients who received driving evaluations through two occu - Denmark Hill, London, UK pational therapists at this time, 9 also participated in NPT Study supported by the UK MS Society and Teva Pharmaceuticals Ltd. within 1 year. These patients served the basis of our chart review. Results: All nine patients reviewed were ambulatory. (P02) Assessment of Depression in Multiple Two had relapses between their NPT and BTW driving evalu - Sclerosis: Validity of Including Somatic ations. For the nine patients, the neuropsychologist concluded Items on BDI-II that one had mild to moderate cognitive impairment, six had Background/Objective: Signs and symptoms of multiple moderate cognitive impairment, and two had moderate to sclerosis (MS) including fatigue may overlap with those of moderately severe impairment. The neuropsychologist (NP)

International Journal of MS Care 2 Platforms and driving evaluators (DEs) were in complete agreement for (P05) Cognitive Impairments in only one patient (recommended driving with hand controls). Relapsing-Remitting Multiple Sclerosis: For the other patients, disagreements occurred between the Quantitative Investigation NP and DE recommendations, in which the NP always rec - Background: Researchers in the past few decades, using ommended more severe restrictions than the DEs. Conclu - tests developed in cognitive psychology and neuropsycholo - sion: Because of the subjective nature and interrater variabil - gy, have attempted to understand the specific cognitive ity between clinical NPT and community-based BTW driving deficits associated with multiple sclerosis (MS). Although con - evaluations, as demonstrated here with the NP and DEs only sensus exists regarding the presence of cognitive impairment in agreement for one out of nine MS patients, a more valid, in these domains, studies differ as to the nature of these cog - reliable, and objective measurable assessment of driving skills nitive impairments and the specific tasks that are used to is needed. One possibility is virtual-reality computer technolo - assess cognitive deficits. Objective: In this meta-analytic gy that can simulate more potential real-life driving hazards review of 57 studies with 3891 participants, the primary in a three-dimensional format in a clinical setting. goal was to investigate the nature and pattern of cognitive Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Jim Ives, OTR/L; Darlene Stough, RN, MSCN, CCRP; Francois Bethoux, MD impairments seen in patients with relapsing-remitting multiple Mellen Center for MS Treatment and Research, Cleveland, OH, USA sclerosis (RRMS) relative to healthy control subjects. Debate in the literature concerns the impact of disease subtype on cog - (P04) Validation of NARCOMS Depression Scale nition, with recent studies suggesting differences in cognitive abilities as a function of disease subtype. For this review, we Background: The North American Research Committee on were primarily interested in studies that specifically examined Multiple Sclerosis (NARCOMS) registry is a self-report reg - the cognitive performance of RRMS patients. Design/ istry for patients with multiple sclerosis (MS). NARCOMS par - Methods: Studies from 1983 to July 2007 were included in ticipants report depression using one question, which has not the current review, yielding a total of 769 effect sizes. The been validated. Objective: We assessed the criterion validi - aggregated or mean effect size was computed with a ran - ty of the NARCOMS depression scale against the Clinical dom-effects model and adjusted for sample size (Hedges Epidemiology Depression Scale (CESD) and self-reported adjusted g) using Comprehensive Meta-Analysis, Version 2.0. diagnoses of depression. Methods: In 2006, 8983 NAR - Results: Results suggest moderate decline in cognitive func - COMS participants reported lifetime diagnoses of depres - tioning in patients relative to healthy control subjects. The sion. Participants completed the CESD, where a score ≥21 largest effect sizes were found for domains of motor function - indicated probable major depression, and the NARCOMS ing, mood and psychological status, and memory and learn - depression scale, which is scored from 0 (no depression) to 5 ing. In addition, we found that several demographic and clin - (total depression). We assessed the criterion validity of the ical variables influenced cognitive performance within the MS depression scale in two ways. First, we compared the depres - sample. Of these, age and sex were found to influence all sion scale to the CESD using Spearman rank correlations with cognitive domains, whereas neurological disability and dis - ease duration were primarily associated with deficits on tasks casewise deletion. Second, we determined the sensitivity and assessing memory and learning. Conclusion/Discussion: specificity of a NARCOMS depression scale score ≥2 for a This meta-analysis suggests that MS is associated with a glob - CESD score ≥21 and for a lifetime diagnosis of depression. al decline in cognitive functioning. Deficits were seen across To assess construct validity, we correlated the depression tasks and across cognitive domains. scale with pain (NARCOMS pain question), fatigue (perfor - Ruchika Prakash, MA; Erin Snook, MA; Jason Lewis; Robert W. Motl, PhD; mance scales subscale), age, and body mass index (BMI). Arthur F. Kramer, PhD Results: The median (IQR) CESD score was 17 (13–23), University of Illinois at Urbana-Champaign, Urbana, IL, USA and the median NARCOMS depression score was 1 (0–2). The depression scale correlated with the CESD ( r = 0.73; (P06) Cognitive Concerns as Predictors of Later 95% confidence interval, 0.72–0.74). For a CESD score Functioning in People With Multiple Sclerosis ≥21, a depression scale score ≥2 had a sensitivity of 78.5% Background: Cognitive difficulties in multiple sclerosis (MS) and specificity of 81.9%. A depression score ≥2 had a sensi - may affect social and role-related functioning, as well as tivity of 87% and specificity of 92% for a lifetime diagnosis of basic and instrumental activities of daily living. Memory depression and current CESD score ≥21. Correlations impairment is the most common cognitive difficulty, affecting between the depression scale and age ( r = –0.03) and BMI 40–60% of people with MS. Although the incidence and (r = 0.10) were low, indicating divergent validity, whereas types of memory problems have been frequently studied, few correlations with pain ( r = 0.39) and fatigue ( r = 0.45) were studies have examined metamemory (self-report of memory moderate, indicating convergent validity. Conclusion: The ability and skills) in people with MS or examined how per - NARCOMS depression scale has adequate criterion and con - ceptions of memory problems may predict later disability. struct validity in MS. Objective: The purpose of this study was to explore the rela - Ruth Ann Marrie, MD, PhD*; Gary Cutter, PhD; Tuula Tyry, PhD; Denise tionships between perceived feelings about memory (eg, con - Campagnolo, MD; Timothy Vollmer, MD fidence, embarrassment), perceived memory ability/failures, *University of Manitoba, Winnipeg, MB, Canada and social and role-related functioning 3 years later. Specifi - Study supported partly by National Institutes of Health, National cally, we explored which contextual factors (age, length of Institute of Child Health and Human Development, Multidisciplinary diagnosis, depressive symptoms) and cognitive concerns (feel - Clinical Research Career Development Program Grant K12 HD04909. ings about memory and memory ability/failures) predict later

International Journal of MS Care 3 Platforms social and role functioning and whether the use of internal intramuscular IFN β-1a for a median of ≥5 years. Enrollment and external memory strategies might moderate relationships in ASSURANCE is expected to be completed soon. Final between cognitive concerns and social, role-emotional, and analyses of clinical outcomes will be presented. role-physical functioning. Design/Methods: A sample of Robert A. Bermel, MD*; Richard A. Rudick, MD; Bianca Weinstock-Guttman, 412 people with MS (344 women, 68 men; mean age 54 MD; Dennis Bourdette, MD; Carlo Tornatorne, MD; Pamela Foulds, MD years; mean time since diagnosis 16.9 years) completed *Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic a survey including measures of demographic and disease- Foundation, Cleveland, OH, USA related variables, the Multifactorial Memory Questionnaire, Study supported by Biogen Idec, Inc. and the Medical Outcomes Study SF-36 in 2003 and 2007. Correlational and hierarchical regression analyses were used (P08) Clinical Characteristics of Neuromyelitis to explore predictors of later functioning. Results: All com - Optica Spectrum Disorders ponents of the metamemory scale were significantly related to Background: The observation of cases of neuromyelitis functioning 4 years later. Years since diagnosis ( b = –.13), optica (NMO) spectrum disorders has made possible the

depressive symptoms ( b = –.39), and cognitive failures/ Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 study of these disorders. Objective: Assess the clinical char - mistakes ( b = –.26) explained 24% of the variance in later acteristics of relapsing NMO (R-NMO), monophasic NMO social functioning. Depressive symptoms and cognitive mis - (m-NMO), recurrent (r-ON), recurrent longitudi - takes explained 21 and 17% of the variance, respectively, in nally extensive transverse myelitis (r-LETM), and associated role-emotional and role-physical functioning. Conclusion: symptoms of the (r-LETM-CNS). Meth - Metamemory related to failures/mistakes was the strongest ods: Sixty-two patients with NMO spectrum disorders were predictor of future functioning after the impact of contextual studied. Results of , magnetic resonance factors. Use of memory strategies did not moderate the effect imaging (MRI), and somatosensory (SSEP), visual (VEP), and of cognitive concerns on future functioning. brain stem (BAEP) evoked potentials were registered. Alexa Stuifbergen, PhD, RN, FAAN; Adama Brown, PhD Results: Clinical forms were 65.6% R-NMO, 21% r-LETM/ The University of Texas at Austin, Austin, TX, USA r-LETM-CNS, 6.6% m-NMO, and 6.6% r-ON. Black patients Study supported by grant R01NR003195, National Institutes of Health, had a longer disease duration (16.4 ± 6.5 years; P = .009) National Institute of Nursing Research. and more relapses (8.2 ± 3.9; P = .0008), and 90% had brain MRI abnormalities, whereas they were present in only (P07) Avonex Long-Term Follow-Up of Patients 11 (42.3%) whites and 6 (40%) mulattos ( χ2 = 7.600, P = With Relapsing Multiple Sclerosis: .022). These results suggest a possible higher resistance and 15-Year ASSURANCE Study tolerance in blacks for R-NMO, r-LETM, more delayed age at Intramuscular interferon β-1a (IFN β-1a; Avonex) significantly onset, attainment of a higher physical disability, and lower reduced the accumulation of physical disability and relapse number of relapses in a short period. Coexisting diseases rate in patients with relapsing multiple sclerosis (RMS) com - (n = 6, 9.6%), associated factors ( n = 12, 19.3%), cases with pared with placebo in the pivotal phase 3 clinical MSCRG familiar forms ( n = 5, 8.1%), and aggressive course were study. In the safety extension of the MSCRG study, during observed. Abnormalities of SSEP/VEP corresponded with the which all patients received open-label IFN β-1a, significant clinical localization. The possible utility of VEP and SSEP seek - treatment effects were observed in the original IFN β-1a group ing for optic nerve or spinal cord subclinical abnormalities compared with the placebo group on mean Expanded Dis - could also be evaluated. The clinical form was relapsing- ability Status Scale (EDSS) score, EDSS change over time, remitting type 1b, and progressive forms were not found. A and percentage of patients reaching EDSS milestones over a cooperative study is in progress to know the course and prog - total of 8 years. These results suggest a significant benefit of nosis of NMO spectrum disorders in the Caribbean. early versus delayed initiation of therapy in RMS. The objec - Jose Cabrera-Gomez, MD, PhD, FAAN*; A. González-Quevedo, MD, PhD; Y. tive of the ASSURANCE study was to evaluate the longer-term Real-Gonzàlez, Lic; D. Grass-Fernández, Lic; M. Cristòfol-Corominas, Prof; impact of early versus delayed initiation of treatment on dis - M.A. Robinson-Agramonte, MD; K. Romero-García, MsC; M.L. Rodríguez- ability. ASSURANCE is an open-label, multicenter, 15-year Cordero, Lic; R. Rodríguez-Roca, MsC; R. Lara-Rodríguez, MD; I. Pérez-Chong, MD; A.Y. Cabrera-Núñez; Mabel Oduardo, MD; M. Rivas-Victor, MD follow-up study that includes patients who received 2 years of *International Center of Neurological Restoration, Playa Havana City, Cuba treatment in the MSCRG study. As of 5 December 2007, 93 of 172 eligible patients had been located and enrolled (com - (P09) Plasma Exchange Accelerates pleted questionnaires or noted as deceased). Forty-two Clearance and Restores Leukocyte Function patients are pending consent or return of information, 35 patients are still being located, and 2 patients declined to Background: Natalizumab (Tysabri) is an anti- α4-integrin enroll. Of the 93 patients, 50 (54%) were originally random - monoclonal that demonstrated significant efficacy in ized to IFN β-1a and 43 to placebo. Of 81 patients still living, pivotal studies of relapsing multiple sclerosis (MS) patients. 74% are women with a mean age of 51.8 years, mean time However, progressive multifocal leukoencephalopathy (PML) since initial MSCRG study enrollment of 16.1 years, and is a rare complication of natalizumab treatment. Currently, mean disease duration of 22 years. Eighty-two percent of immune reconstitution is the only intervention shown to be patients live independently, and 91% of patients completed effective in improving outcomes in patients with PML. Plasma the questionnaire by themselves. Since entry into MSCRG, exchange (PLEX) may accelerate clearance of natalizumab patients have used a mean of two disease-modifying thera - and therefore may increase leukocyte migration into the cen - pies for MS. Fifty-four percent of patients have been taking tral nervous system and improve the clinical outcome in the

International Journal of MS Care 4 Platforms event of PML. Methods: Three 1.5-volume exchanges were Results: Results from subgroup analyses were consistent with performed over 5 or 8 days in 12 patients with MS 10–14 the overall results. BG00012 720 mg/day reduced the num - days after ≥3 monthly infusions with natalizumab 300 mg. ber of new Gd+ lesions from week 12 to week 24 compared Serum natalizumab concentrations and mononuclear cell α4- with placebo: EDSS ≤2.5, 1.2 vs 4.6 (76%, P = .006); EDSS integrin-receptor saturation were evaluated daily throughout >2.5, 1.6 vs 4.3 (63%, P = .002); 0 Gd+ lesions, 0.6 vs 3.0 the PLEX course and three times over the subsequent 2 weeks. (80%, P = .005); ≥1 Gd+ lesion, 3.0 vs 6.7 (55%, P = Peripheral mononuclear cells (PBMCs) from a subset of .003); age <40 years, 2.0 vs 3.9 (49%, P = .009); age ≥40 six patients were assessed for chemokine CCL2-induced years, 0.6 vs 5.7 (89%, P = .002); men, 1.8 vs 2.9 (38%, migration across an in vitro blood-brain barrier (ivBBB) during P = .063); women, 1.1 vs 5.7 (81%, P < .001). Conclu - natalizumab treatment and after PLEX. Pharmacokinetic mod - sions: BG00012 reduced the accumulation of new Gd+ eling was performed based on concentration and saturation lesions across subgroups of RRMS patients defined by age, data from all 12 patients undergoing PLEX in the current study sex, disability, and baseline MRI activity. and 245 patients who participated in a phase 3 study of Ludwig Kappos, MD*; David H. Miller, MD; David G. MacManus, MSc; Ralf

natalizumab. Results: Immediately after PLEX, mean serum Gold, MD; Eva Havrdova, MD; Volker Limmroth, MD, PhD; Chris H. Polman, Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 natalizumab concentrations were reduced by ≥95% versus MD, PhD; Klaus Schmierer, MD; Tarek A. Yousry, MD; Minhua Yang; Mefkure baseline. Decreases in serum natalizumab concentrations to Eraksoy, MD; Eva Meluzinova, MD; Ivan Rektor, MD, CSc; Kate Dawson, MD; <2 µg/ml resulted in subsequent decrease in α4-integrin- Gilmore N. O’Neill, MB, MRCPI, MMedSc receptor saturation. PLEX resulted in a 2.2-fold increase in *University Hospital Basel, Basel, Switzerland PBMC migration across the ivBBB ( P < .006). Measures for Study supported by Biogen Idec, Inc. optimizing the efficiency of PLEX as suggested by pharmaco - kinetic modeling will be presented. Conclusions: Based on (P11) Efficacy With Early Use of in its ability to accelerate the clearance of natalizumab and Multiple Sclerosis Is Independent of Baseline restore the migratory capacity of leukocytes, PLEX holds Disease Status potential for immune reconstitution in the setting of suspected Background: Preliminary studies suggest that the lympho - or confirmed cases of PML associated with natalizumab cyte-targeting monoclonal antibody alemtuzumab markedly administration. suppresses disease activity when administered during early Robert Fox, MD*; Shumei Man, MD, PhD; Barbara Tucky, BSc; Jar-Chi Lee, stages of relapsing-remitting multiple sclerosis (RRMS). The MS; Anna P. Koo, MD; Gavin Giovannoni, MBBCh, PhD; Bhupendra O. Khatri, randomized, multicenter, rater-blinded phase 2 study MD; Susan Goelz, PhD; Frances Lynn, MSc; Stephanie Jurgensen, MPH; James Woodworth, PhD; Petra Duda, MD, PhD; Michael A. Panzara, MD, MPH; CAMMS223 compares alemtuzumab with high-dose interfer - Richard M. Ransohoff, MD on β-1a (IFN β-1a) in treatment-naive RRMS. A subgroup *Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, Cleveland, analysis of the year 3 data evaluated the role of baseline dis - OH, USA ease status in efficacy. Design/Methods: Participating Study supported by research grants K23NS47211, K24NS51400, and patients were treatment naive, with onset of symptoms within P50 NS38667, Biogen Idec, and Elan Pharmaceuticals. 3 years of screening, Expanded Disability Status Scale (EDSS) scores of 0–3.0 inclusive, two or more attacks in the (P10) BG00012 Reduces Accumulation of past 2 years, and one or more enhancing lesions on cranial Gadolinium-Enhancing Lesions in Subgroups of magnetic resonance imaging (MRI) screening. A total of 334 Multiple Sclerosis Patients patients were randomized 1:1:1 to IFN β-1a 44 µg three Background: BG00012 is an oral formulation of dimethyl times/week or annual cycles of low-dose (12 mg/day) or fumarate that has a distinct dual mechanism of action, target - high-dose (24 mg/day) intravenous alemtuzumab. Alem - ing an important neuroprotective and anti-inflammatory path - tuzumab was administered for 5 days at month 0, 3 days at way. During the phase 2b study in relapsing-remitting multiple month 12, and, in some patients, 3 days at month 24. Co– sclerosis (RRMS) patients, BG00012 240 mg by mouth (PO) primary efficacy endpoints were time to 6-month sustained three times daily (tid) significantly reduced the number of new accumulation of disability (SAD) and relapse rate. Results: β gadolinium-enhancing (Gd+) lesions from week 12 to week Compared with patients treated with IFN -1a, alemtuzumab- 24 by 69% versus placebo ( P < .001). Analyses were con - treated patients overall demonstrated a 73% reduction in risk ducted to determine whether the primary efficacy results from for relapse ( P < .0001) and a 70% reduction in risk for SAD the BG00012 phase 2b study were consistent among (P < .0001) after 3 years of treatment. Subgroup analyses of patients with different baseline characteristics. Methods: the co–primary endpoints indicated that alemtuzumab’s treat - The phase 2b study was a placebo-controlled trial. Two hun - ment effects are largely independent of disease duration dred fifty-seven RRMS patients were randomized to receive (<2/ ≥2 years), baseline EDSS ( ≤1.5/ ≥2.0), relapse rate one of four treatments during a double-blind, 24-week treat - (≤2/>2 relapses in past 2 years), cerebral volume on MRI T1 ment period: BG00012 capsules 120 mg PO once daily, (<320/ ≥320 ml), or MRI T2 lesion volume (<10/ ≥10 ml). 120 mg PO tid, 240 mg PO tid, or placebo. The primary Conclusions/Relevance: Alemtuzumab is significantly endpoint was the total number of new Gd+ lesions over cra - more effective than IFN β-1a at suppressing relapses and dis - nial magnetic resonance imaging scans at 12, 16, 20, and ability progression in patients with RRMS through 3 years of 24 weeks. Data on the primary endpoint were analyzed in follow-up regardless of pretreatment relapse rate or baseline the following subgroups: Expanded Disability Status Scale disease duration, disability, cerebral volume, or lesion load. (EDSS) score ( ≤2.5, >2.5) at baseline, presence of Gd+ A comprehensive safety-monitoring program has effectively lesions (0, ≥1) at baseline, age (<40, ≥40 years), and sex. minimized morbidity caused by side effects of alemtuzumab

International Journal of MS Care 5 Platforms such as thyroid disorders, infection, and immune thrombocy - plan plus eight scheduled telephone counseling sessions to topenic purpura. promote adherence to the plan. Primary outcome: Hamil - Ann Doan-Do Bass, MD*; CAMMS 223 International Study Group ton Rating Scale for Depression (HAM-D) was the primary *Neurology Center of San Antonio, San Antonio, TX, USA outcome. Secondary outcomes were Hopkins Symptom Study supported by Genzyme Corporation. Checklist (SCL-20), metabolic equivalent units (METs) as esti - mated by the 7-Day Physical Activity Recall, minutes of exer - (P12) Importance of Clinically Defined Spatial cise, and the Modified Fatigue Impact Scale (MFIS). Analy - Dissemination for Prediction of Multiple Sclerosis Risk ses: Intent-to-treat analysis of posttest outcomes, controlling for pretest, was performed. Results: Of the sample, 85% Objective: Investigate the value of clinically defined dissemi - were women, 92% were white, and 75% had relapsing MS. nation in space for predicting time to clinically definite multi - Randomization was effective, although the treatment group ple sclerosis (CDMS) and the added prognostic value of mag - had higher HAM-D scores at baseline. Efficacy analyses netic resonance imaging (MRI) parameters. Background: A demonstrated that, at 12 weeks, significant improvement was diagnosis of MS requires evidence for spatial dissemination seen on the HAM-D in the treatment group (17.7 to 11.4) but of central nervous system lesions. Clear guidelines delineate Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 not among control subjects (15.8 to 14.2; P = .0005). Simi - how to derive this evidence from MRI findings, but no defini - lar results emerged on the SCL-20 ( P = .002) and MFIS ( P < tion of how a patient’s symptoms and signs can indicate dis - .0001). Nonsignificant trend was found for exercise, as ease dissemination exist. To provide a uniform approach, measured by METs, to improve more in the treatment versus a clinical system has recently been described for the classifi - control group ( P = .08). Conclusion: This intervention is a cation of patients with a first event as having monofocal promising approach for treating MD in people with MS who (symptoms being explained by a single lesion) or multifocal can walk but are not exercising regularly. Mechanisms other (symptoms only explained by the presence of >1 lesion) pres - than exercise dose may account for the antidepressant effect. entation. Methods: As part of the ongoing BENEFIT studies, Future research should include an attention control group and 468 patients with a first event suggestive of MS were classi - methods to identify potential biopsychosocial mediators of the fied centrally by two neurologists blinded to MRI results and antidepressant effect of this intervention. followed for up to 2 years. Two hundred ninety-two patients were randomized to interferon β-1b and 176 to placebo. The Charles Bombardier, PhD; Dawn Ehde, PhD; Rohini Wadhwani, BS; Laura E. Gibbons, PhD; Chiara LaRotunda, MSW; Celeste Hunter, MA; Kerry Madrone, risk for CDMS was studied with Kaplan-Meier statistics in MSW; Kendra Wight, BA; Mark Sullivan, MD, PhD; George Kraft, MD, MS placebo-treated patients with mono- and multifocal disease, University of Washington School of Medicine, Seattle, WA, USA both with and without the presence of MRI parameters of Study supported by the Multiple Sclerosis Rehabilitation Research and potential prognostic relevance. Results: No difference was Training Center (H133B031129) funded by the National Institute on found between patients with monofocal and multifocal presen - Disability and Rehabilitation Research. tation in terms of time to CDMS. In monofocal patients, the risk for CDMS over 2 years was significantly higher in those (P14) Multiple Sclerosis Patients Pace Their who had nine or more T2 lesions at the first event or one or Activities During Day-and-a-Half Testing more gadolinium-enhancing lesions at the first event or 3 or 6 months later. These MRI parameters had no significant predic - Background: People with multiple sclerosis (MS) suffer from tive value for time to CDMS in patients with a multifocal pres - overwhelming fatigue and reduced function that limits their entation. Conclusion: These data indicate that a carefully ability to sustain normal daily activities. Objective: This performed neurological assessment of symptoms and signs is study determined the effects of a simulated workday on physi - important for determining the risk of conversion to CDMS. ologic and functional performance and fatigue during the Jessica Nielsen, MD*; Chris H. Polman, MD, PhD; Frederik Barkhof, MD, PhD; day and the next morning, after a normal night’s rest for indi - Mark Freedman, MD; Gilles Edan, MD; Ludwig Kappos, MD; David Miller, viduals with MS. Design/Methods: Sixty-nine MS patients MD; Lars Bauer, MD; Christoph Pohl, MD; Rupert Sandbrink, MD, PhD; with Expanded Disability Status Scale scores ≤6.5, aged Bernard M.J. Uitdehaag, MD, PhD 47.1 ± 7.5 years, and 17 control subjects, aged 46.0 ± VU University Medical Center, Amsterdam, The Netherlands 10.8 years, participated in three test batteries (morning, end Study supported by Bayer Schering Pharma AG, Berlin, Germany. of day, and next morning) over 1.5 days. Testing included maximal neuromuscular (strength, endurance, velocity) and (P13) Telephone-Based Exercise Promotion for maximal cardiorespiratory (VO 2, heart rate, blood pressure, Major Depression in People With Multiple Sclerosis lactate) function, functional performance (walking, stair climb - Background: Major depression (MD) is prevalent and dis - ing, reaction time), cognitive function (PASAT), and fatigue abling among people with multiple sclerosis (MS). Epidemio - (Buffalo Fatigue Scale). During the remainder of the day, the logic and experimental studies suggest that exercise is a subjects performed sedentary (1MET) to slightly active promising treatment for MD. We chose a telephone-based (3METs) activities (ie, reading, computer work, low-level approach because it can be effective and overcomes arm/leg pedaling) to simulate the energy expenditure during barriers to treatment. Method: Subjects were 101 communi - a typical workday. Results: Significant differences ( P < .05) ty-residing people with a confirmed diagnosis of MS and MD were found between MS and C on all functional variables who were ambulatory and not exercising regularly. Partici - and most neuromuscular and cardiorespiratory variables. MS pants underwent a baseline assessment and were random - reported higher levels of fatigue for lower levels of physiolog - ized to a 12-week treatment condition ( n = 50) or a wait-list ic work than C. No significant differences were found within control group ( n = 51). Treatment consisted of a single face- MS or C for the three test periods, except for physical and to-face motivational interview to negotiate a home exercise cognitive fatigue. MS did not have a complete recovery in

International Journal of MS Care 6 Platforms physical or cognitive fatigue by the next morning ( P < .05). the typical NH population. Objective: Investigate the extent Even with increased perceived fatigue by the MS subjects, and characteristics of MS patients with severe, sustained dis - they were able to perform to the same level at the end of the ability followed at a specialized MS center, and identify fac - day and the next morning as they did at the beginning of the tors that may predict admission to an NH compared with first day. Conclusions/Discussion: The MS group seemed home-based care (HBC). Methods: The Baird MS Center to pace their activities over the day, thereby sustaining physio - database, a constituent of the New York State MS Consor - logical and functional performance over time; however, they tium, was queried for patients with an advanced sustained had increased fatigue and time to recovery from fatigue. disability, defined as an Expanded Disability Status Scale Nadine Fisher, EdD*; James Graham, PhD; Carl Granger, MD (EDSS) score ≥7.0. Demographic characteristics, education, University at Buffalo, Buffalo, NY, USA marital and insurance status, and ever-used disease-modifying Study supported by the National Institute on Disability and Rehabilita - therapies were considered in the analysis. Results: Of data tion Research, US Department of Education (H133G010132). extracted from 1850 registered MS patients, 369 had EDSS ≥7.0 (74% women, 92% white). Twenty-one percent were

(P15) CRISP : Community Reintegration for Socially NH residents. No difference in age at MS onset (NH mean Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Isolated Patients [SD] 31.4 [9.1] vs HBC 32.5 [9.9] years) and no significant difference in sex, race, education, disease type, family histo - Multiple sclerosis (MS) has a profound effect on social well- ry, and ever-used disease-modifying drugs were found being. For individuals with advanced disease, every daily between NH residents and HBC patients. Significant vari - activity becomes increasingly difficult, especially when leav - ables that appear to predict NH versus HBC found in adjust - ing home. From transportation to accessibility, every step of a ed logistical regression models (odds ratio [95% confidence trip must be thoroughly planned. In addition to physical barri - ers, clients are afraid of being stigmatized because of their interval]) were marital status (single/divorced/widowed vs MS symptoms or fear becoming disoriented because of cogni - married, 4.1 [2.0–8. 5]; P = .000), insurance status (private tive impairments. Many MS clients avoid social outings, lead - vs public, 4.7 [1.4–16.5]; P = .017), bowel/bladder dys - ing to isolation and depression, which directly affect psy - function (1.5 [1.2–1.8]; P = .000), and cerebral dysfunction chosocial well-being and quality of life (QOL). Community (1.7 [1.3–2.1]; P = .000). Conclusion: Twenty-one percent Reintegration for Socially Isolated Patients (CRISP) is a pro - of MS patients with comparable disability are NH residents, gram addressing isolation in MS by combining educational versus living alone or with a family member in HBC. Marital treatment with recreational therapeutic activities to help tackle status, insurance provider, bowel/bladder dysfunction, and impediments of living with a disability. Groups of 10–15 cognitive impairment are the strongest predictors for need of clients are taken to Broadway shows, museums, concerts, NH care. Models of constructive interventions to keep these operas, sporting games, and other exciting events. Clients are young individuals in an HBC environment are essential. educated concerning community resources, accessibility, trans - Cornelia Mihai, MD*; Barbara Teter, MPH, PhD; Napur Batra, MD; Bianca portation, safety, and independence. For subsequent outings, Weinstock-Guttman, MD; Carl Granger, MD; Allison Drake, MS; Paulette clients are required to actively participate in the planning and Niewczyk, MPH, PhD; Robert Zivadinov, MD, PhD; Frederick Munschauer, MD execution of the event. The program also serves as a setting *Jacobs Neurological Institute, New York State Multiple Sclerosis Consortium, Buffalo, NY, USA for clients to develop social networks and support systems for one another. Efficacy of the program was assessed by admin - (P17) Multiple Sclerosis Literacy: Gap Between istering a self-rated QOL questionnaire that we developed to Need to Know and Know the Need a sample of 50 clients (from >200) who participated in the CRISP program during the past year. Ninety-six percent of Objective: Evaluate multiple sclerosis (MS)-specific health lit - clients rated the program positively. Most of them had not left eracy of a sample of MS patients seen at the Mellen Center, their homes for a social event in months. Examples of topics and survey MS clinician expectations for health literacy. included inspiration to socialize more often and having a Background: A core aspect of self-management of a chron - sense of feeling less isolated. Clients have begun making ic disease is a working knowledge of key terms used to plans with others they met at events (eg, dinner plans or describe that disease and its management. In MS, many med - shows) and overall report feeling less isolated. Over the next ical terms are used by health care professionals. We evaluat - 6 months, durability of the program will be assessed. ed the MS-specific literacy of a sampling of our MS popula - Jennifer Fromm, MS, OTR/L, CCRC; Josh Bacon, PhD; Jennifer Shuldiner; tion and compared this with our team’s expectations. We also Channa Klein; Rhea de Guzman, MS; Miriam Duhan, OTS; Ilya Kister, MD; evaluated whether other measures of general health literacy Joseph Herbert, MD correlated with MS-specific literacy. Design/Methods: This NYU Hospital for Joint Diseases, New York, NY, USA was a pilot project, with a convenience sample of patients Study supported by Christopher and Dana Reeves Foundation, currently cared for at the Mellen Center for MS, Cleveland Teva Neuroscience. Clinic. Patients were asked to define 12 MS-related terms (eg, demyelination , axon , white matter ). Duration of MS, edu - (P16) Factors Related to Nursing Home Versus cation, and general health-literacy questions were also Home-Based Care in Patients With reviewed. Responses were scored as not known, wrong, par - Multiple Sclerosis tially right, or correct. Results: Twenty-four patients were sur - Background: Multiple sclerosis (MS) is a progressive dis - veyed with two sets of 12 MS-related terms. Patient character - ease, and many patients ultimately develop severe disability istics included age 45 ± 10 years, time since diagnosis 7.7 ± requiring extensive, long-term care. Patients with MS who are 7.0 years, 71% women, 8% black, 92% white, 21% nursing-home (NH) residents are often distinctly younger than high school education, 50% some college, 21% bachelor’s

International Journal of MS Care 7 Platforms degree, 8% graduate degree. Perception about general (P20) Exaggerated Startle Response health literacy correlated moderately with MS-specific literacy (Hyperekplexia) in Multiple Sclerosis: (Spearman correlation = 0.55182, P = .0052). No signifi - Review of 20 Patient-Reported Cases cant correlation was found with sex, education, or ethnicity. Exaggerated startle response or hyperekplexia (also known Twelve Mellen Center clinicians felt that patients should under - as hyperexplexia) is not recognized to be associated with stand 17.2 ± 2.8 out of 24 terms related to MS (range 11– multiple sclerosis (MS). It is not mentioned in MS reviews or 23 terms). Patients gave correct definitions for MS-related textbooks; only one MS case report was found in the litera - terms 17% of the time. Conclusions/Relevance: A gap ture review. The purpose of this presentation is to increase the exists between need-to-know MS-related terms and the pilot awareness of this symptom in MS. Thirty-seven patients self- sample’s demonstrated knowledge. We conclude that further reported startle response after an inquiry in the MS Associa - sampling of larger populations will help us know the need in tion of America’s (MSAA) “Ask the Doctor” column in their terms of literacy for MS-specific terms. magazine The Motivator . This unexpected high response Alexander Rae-Grant, MD, FRCP(c) prompted a literature review on hyperekplexia. Most cases of Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Cleveland Clinic, Mellen Center, Cleveland, OH, USA hyperekplexia in the medical literature are related to heredi - tary neonatal hyperekplexia and posttraumatic stress disorder (P18) Withdrawn (PTSD). Hyperekplexia involves an overactive autonomic arousal, which creates difficulty discriminating and interpret - (P19) Comparing Sleep Problems in Multiple ing stimuli. The primary treatment reported in the literature Sclerosis Via Women’s Health Initiative Insomnia has been clonazepam. No MS patients received clon - Rating Scale and Medical Outcomes Study azepam. Thirty of the 37 respondents completed the survey. Sleep Scale Startle was usually precipitated by auditory (82%), visual (17%), tactile (6%), or a combination of stimuli. The average Background: Research studies suggest that that up to 50% age at onset of MS symptoms was 26 years, and the onset of of individuals with multiple sclerosis (MS) complain of sleep- startle was at age 35 years. Fewer than 20% of MS patients related problems. However, sleep difficulties have received had startle before their MS, which suggests previous trauma comparatively little research attention in MS, and few large- scale sleep studies have been completed to date. Because (PTSD) is not related. Other data include the following: 67% sleep is known to have a substantial effect on quality of life, it have relapsing-remitting MS, 93% reported multiple episodes is important to examine the prevalence of sleep disorders and per day, and 90% have an exaggerated startle response at functioning of sleep instruments in individuals with MS. The least once a week, half of whom experience startling at least purpose of this study was to estimate the prevalence of sleep daily. Hyperekplexia was variously described as frightening, difficulties in MS with two sleep scales and evaluate the psy - embarrassing, painful, dangerous (falling), and disruptive to chometric functioning of both measures in an MS population. personal and professional relationships. A total of 73% had Methods: A large cross-sectional sample ( N = 1063) of not had discussions with any health care professional, and community-dwelling individuals with MS completed a self- 17% reported that their doctors stated that startle might be report mail survey. Sleep was assessed with the Medical Out - related to MS but had no therapeutic suggestions. In conclu - comes Study Sleep Scale (MOSSS) and the Women’s Health sion, hyperekplexia is an underrecognized but potentially Initiative Insomnia Rating Scale (WHIIRS). Both measures treatable symptom of MS. Increased recognition and under - were scored based on recommendations of scale developers, standing will promote treatment options. and summary statistics were calculated. Item response theory Jack Burks, MD*; Miriam Franco, MSW, PsyD; Andrea L. Griesé; Susan Wells (IRT) with a graded response model was used to evaluate the Courtney; John J. Masino psychometric functioning of the scales. Results: Mean scores *University of Nevada School of Medicine, Reno, NV, USA on the WHIIRS and MOSSS Sleep Index II were 9.8 (stan - dard deviation 5.3) on a scale of 0–20 and 38.9 (19.7) on (P21) Withdrawn a scale of 1–100, respectively. These scores indicate that individuals with MS have significantly more sleep problems (P22) Effect of Exercise Training on Walking than the general population and other chronically ill popula - Mobility in Multiple Sclerosis: Meta-Analysis tions. IRT analysis found that both scales have significant num - bers of misfitting items, and response categories did not per - Background: Exercise training is a promising behavioral form as expected. Both scales measured individuals with strategy for mitigating reductions in walking mobility among more sleep difficulties more accurately than those below the people with multiple sclerosis (MS). To date, the existing mean of this sample. Conclusions: Sleep difficulties appear research has not uniformly provided evidence for a beneficial to be a significant problem for a large percentage of individu - effect of exercise on walking mobility in MS, and the magni - als with MS. Further research on sleep difficulties in MS and tude of the influence of exercise training on walking mobility development of better measurement tools for evaluating sleep has varied considerably. Such issues underscore the impor - difficulties are needed. tance of conducting a quantitative synthesis of the magnitude Alyssa Bamer, MPH; Dagmar Amtmann, PhD; Karon Cook, PhD; Kurt of the overall effect of exercise training on walking mobility in Johnson, PhD MS. Objective: This study examined the overall effect of University of Washington, Seattle, WA, USA exercise-training interventions on walking mobility among Study supported by grants from the US National Institute on Disability individuals with MS via meta-analytic procedures. Methods: and Rehabilitation Research (#H133B031129) and the National Insti - We conducted a search for published exercise-training studies tutes of Health (#5U01AR052171-03) to the University of Washington. across the period 1960 to November 2007 with MEDLINE,

International Journal of MS Care 8 Platforms

PsychINFO, CINAHL, and Current Contents Plus. Studies of symptomatic UTIs in neurogenic patients. However, were selected if they measured walking mobility, with instru - because of the limited number of patients, further large ments identified as acceptable walking-mobility constructs, prospective studies with longer follow-up are needed to con - and outcome measures for individuals with neurological disor - firm these observations. Until these studies are completed, use ders, before and after an intervention that included exercise of this type of catheter may be considered as a treatment training. Results: Forty-three articles were located and option for MS patients with recurrent UTIs who require inter - reviewed, and 22 provided enough data to compute effect mittent catheterization or use chronic urethral or suprapubic sizes. Sixty-six effect sizes were retrieved from the 22 publica - catheters for bladder management. In our experience, to tions, with 600 MS participants. The distribution of the effects date, this catheter has not resulted in any additional cost to had slight negative skewness (g1 = –0.07) and leptokurtosis the patient. (g2 = 0.89). Fifty-four effect sizes were >0. The weighted Margie O’Leary, MSN, RN, MSCN; Janet Okonsi, BS, CCRT; Jill Bischoff, mean effect size (g = 0.19) was significantly different from 0 CRNP; Marc Smaldone, MD; Michael B. Chancellor, MD (95% confidence interval, 0.09–0.28). The fail-safe κ was *University of Pittsburgh MS Center, Pittsburgh, PA, USA

285. The funnel plot suggested against publication bias. The Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 moderator analysis indicated that larger effects were associat - (P24) Discrepancies in Subjective and Objective ed with supervised exercise training, exercise programs that Outcomes With Intrathecal Baclofen Therapy were <3 months long, and mixed samples of relapsing-remit - Background/Objective: The intrathecal baclofen (ITB) ting and progressive MS. Conclusions: The cumulative evi - pump has been effective in managing spasticity in patients dence supports that exercise training is associated with a with multiple sclerosis (MS), but little is known about what small but meaningful improvement in walking mobility among influences patient perceptions of treatment effects or how their individuals with MS. definition of success compares with objective assessments. Robert Motl, PhD; Erin Snook, MS Design/Methods: Ten ambulatory MS patients with severe University of Illinois at Urbana-Champaign, Urbana, IL, USA spasticity aged 31–52 years (90% women, 100% white, Study supported by the National Institute of Neurological Diseases and 40% married, and 50% employed) referred to the Mellen Stroke (NS054050). Center Spasticity Clinic underwent implantation of a baclofen pump. At baseline and 1-, 3-, and 6-month follow-ups, meas - (P23) Observations on Use of Nitrofuranzone- ures included 25-foot walk, SF-36, and MOS Pain Effects Impregnated Urinary Catheters in Patients With Scale, as well as patient ratings of change in symptoms and Neurogenic Bladder and Multiple Sclerosis function, satisfaction, and likelihood of repeating the proce - Asymptomatic bacteriuria is a common problem in patients dure at 1, 3, and 6 months. Results: No patients showed with multiple sclerosis (MS). It is associated with use of inter - consistency between the subjective (likelihood of repeating) mittent catheterization and indwelling catheters, both urethral and objective (timed walk) outcome (ie, positive or negative) and suprapubic. Symptomatic urinary tract infections (UTIs) in at all three follow-ups. Three patients were consistent at two people with MS include fever, hematuria, fatigue, urinary points, with the remainder consistent at no more than one urgency, frequency, and incontinence, which result in hospital - point. At any one follow-up, at least half the sample had con - izations, pseudo-exacerbations, and loss of productivity. Long- sistent outcomes. Patients with consistency between the sub - term risks of recurrent UTIs can include the development of jective and objective outcome at any follow-up also reported resistant organisms within urine, stone formation, and renal stable or positive change in symptoms at the same follow-up failure. Methods: Seven patients with MS and one patient and were neutral, satisfied, or very satisfied with ability to with transverse myelitis, all with a history of recurrent sympto - control symptoms, function, and quality of life related to the matic UTIs, were managed with nitrofuranzone-impregnated pump. Patients with inconsistency between the subjective and urinary catheters. Indwelling catheters were routinely changed objective outcome at any follow-up, specifically those with every 3–4 weeks. Urine analysis and cultures were per - greater likelihood of repeating the procedure who also expe - formed at the time of the catheter change and when the rienced no improvement in gait speed, reported stable or patient reported feeling ill. With the patients who performed improved physical health and worsening effects of pain. clean intermittent catheterization (CIC), urine tests were Conclusion/Discussion: The findings illustrate consider - ordered only when the patient reported feeling ill. Rates of able inconsistency between how patients subjectively and cli - symptomatic infections were monitored over a 6-month peri - nicians objectively define success with ITB therapy. This od. Patients were assessed by phone and during routine clini - emphasizes the need to identify specific and meaningful cal visits. Results: The data in the presentation document the patient goals at baseline and follow them throughout treat - symptomatic infection rates before and during the observa - ment. Potential application of this model to additional MS tion period. The primary outcome symptomatic UTI was treatments will be discussed. reduced overall in four of eight patients over a 4-month peri - Noah Webster, MA*; Peggy Crawford, PhD; Darlene Stough, RN; Francois od. No skin irritations or allergic responses were noted or Bethoux, MD observed. Conclusions: Our results suggest that use of nitro - *Case Western Reserve University, Ann Arbor, MI, USA furanzone-impregnated urinary catheters may reduce the risk Study supported by Medtronic Inc.

International Journal of MS Care 9 Posters

was not to blame for their MS, 28.6% did not know, 19% Posters believed that MS was a punishment from God, and 33.4% (S01) Withdrawn perceived MS as an opportunity from God. The poor group had 6 people, of whom 33.3% said that they were not close (S02) Persistence to Therapy Among Patients to God; 83% reported that there were people in their lives Enrolled in Multiple Sclerosis LifeLines whom they had not been able to forgive. Also, 16.7% report - Background: Interferon β-1a subcutaneous (IFN β-1a SC) ed being disappointed with God, 16.7% believed that God therapy is indicated for the treatment of patients with relaps - was not to blame for their MS, 16.7% did not know, 16.7% ing forms of multiple sclerosis (MS) to decrease clinical exac - prayed for a cure from God, and 33.2% reported that God erbations and delay the accumulation of physical disability. helped them cope with their MS. The quality of life was not Adherence is a challenge for many patients receiving therapy affected by Expanded Disability Status Scale score, religion, with disease-modifying drugs (DMDs). MS LifeLines is an edu - age, marital status, or maternity/paternity. The time since MS cational support service provided by EMD Serono, Inc., and diagnosis was longer in the great group, showing that as time passed, patients were able to better cope with MS.

Pfizer Inc. for the MS community. Objective: Describe 1- Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 year persistence to therapy among MS patients receiving Conclusion: Religious beliefs can affect the coping mecha - IFN β-1a SC as second-line therapy and using the MS LifeLines nisms of people with MS, but further studies should be program. Design/Methods: The study includes patients performed. (18–65 years old) with relapsing forms of MS who started Gina Amoroso, OT*; Lorena Allemandi IFN β-1a SC treatment between September 2005 and Septem - *ABEM, Sao Paulo, Sao Paulo, Brazil ber 2006 and were enrolled in MS LifeLines. To ensure treat - Study supported by the Brazilian MS Society. ment adherence, nursing staff contacted patients monthly dur - (S04) Annual Indirect Health Care Costs Among ing the first 6 months of therapy and every 3 months Employees With Multiple Sclerosis thereafter. Persistence was defined as the percentage of patients who remained on therapy 12 months after treatment Background: In addition to the direct costs of therapy, mul - initiation with IFN β-1a SC. Persistence was reported for the tiple sclerosis (MS) involves indirect costs such as comorbidi - total study population and for three separate cohorts defined ties and absenteeism from work. Objective: Annual indirect by their previous treatment: IFN β-1a intramuscular (IM), IFN β- health care costs of privately insured US employees with mul - 1b, or (GA). Results: A total of 4054 tiple sclerosis (MS) were compared with matched employee patients were included in the analysis. The overall 1-year per - controls. Design/Methods: Employees aged 18–64 years sistence for IFN β-1a SC patients enrolled in MS LifeLines was with ≥1 MS diagnosis after 1 January 2002 were selected 83.2%. Persistence rates for patients taking IFN β-1a SC were from a database containing disability data from 17 US pri - similar to those of patients previously treated with IFN β-1a IM vate insurers. Employees with MS were matched by age and (n = 2131), GA ( n = 1450), and IFN β-1b ( n = 473); the sex to an employee control group without MS. Members of rates were 85.2, 81.2, and 81.0%, respectively. Conclu - the MS group had to have continuous health coverage 3 sion/Discussion: Patients enrolled in the MS LifeLines pro - months before diagnosis (baseline) and 12 months after gram appear to have similar persistence to their prior DMD (study period). χ2 tests were used to compare factors such as therapy. Additional research is needed to validate these find - baseline comorbidities and differences in indirect resource ings in a larger population and to determine whether enroll - use (disability and medically related absenteeism). Wilcoxon ment in a patient support program affects persistence rates. rank sum tests compared mean disability and medically relat - Ahmad AL-Sabbagh, MD; Randy Bennett; Contessa Fincher, PhD, MPH; ed absenteeism days and associated annual indirect costs. Dennis Meletiche, PharmD; Jo Scanzillo, RN, MSCN Results: The average age of employees with MS ( n = 989) EMD Serono, Inc., Rockland, MA, USA was 44 years; 76% were women. Compared with employee Study supported by EMD Serono, Inc., and Pfizer Inc. controls, employees with MS had significantly higher rates of comorbid neurological and mental health disorders. Employ - (S03) Religious Beliefs and Quality of Life of ees with MS were also more likely to have short- or long-term People With Multiple Sclerosis disability than controls (21.4 vs 5.2%; P < .0001) and had Objective: The purpose of this study was to analyze the more mean number of disability days per year (29.8 vs 4.5; influence of religious beliefs on the quality of life of people P < .0001). The rates of medically related absenteeism days with multiple sclerosis (MS). Methods: We used an open were also higher for employees with MS than controls. On questionnaire about religious beliefs and Functional Assess - average, annual costs for disability were $3868 for employ - ment of Multiple Sclerosis (FAMS). Four groups were formed ees with MS and $414 for employee controls ( P < .0001). by using the FAMS score, classified as great (mean + 2SD), Medically related absenteeism costs were also higher in the good (mean + SD) , regular (mean – SD), and poor (mean – group with MS than controls ($1901 vs $1003; P < .0001). 2SD). Results: The great group had 8 people, of whom Total indirect costs averaged $5769 for employees with 88.5% believed that God has a role in their having MS. One MS and $1417 for controls ( P < .0001). Conclusion/ person believed that MS is a punishment from God, and Discussion: Indirect costs of employees with MS were, on 12.5% related that they met God with the MS. The good average, more than four times those of employee controls. group had 21 people, of whom 28.6% believed that God Howard G. Birnbaum, PhD*; Jasmina I. Ivanova, MA; Seth Samuels, BA; was not to blame for their MS, 9.5% did not know, and Matt Davis, BA; Amy Phillips, PharmD; Dennis Meletiche, PharmD 61.9% perceived MS as an opportunity from God. The regu - *Analysis Group, Inc., and EMD Serono, Inc., Boston, MA, USA lar group had 21 people, of whom 19% believed that God Study supported by EMD Serono, Inc., and Pfizer Inc.

International Journal of MS Care 10 Posters

(S05) Motivational Counseling and Strengthening [Rebif]) were eligible for analysis. No eligible natalizumab Exercises in Patients With Multiple Sclerosis [Tysabri] patients were found in the data. Aside from small geographic differences, all patients were similar demographi - Background: Exercise is important in managing multiple cally. Avonex patients reported the least lost time from sick sclerosis (MS). However, little is known about methods of leave and short-term disability among the DMTs (4.83 total encouraging exercise in MS patients. Methods: Sequential days/year). Rebif patients had the highest lost time (20.67 ambulatory MS patients were randomized to motivational days), followed by Copaxone (13.97) and Betaseron (7.33). interviewing or usual care. Telephone counseling was repeat - Of these, Copaxone patients had more days of sick leave ed at 2 weeks and 1, 2, 3, 6, 9, 12, 18, and 24 months. (7.18 vs 2.98; P = .0101) and short-term disability (6.79 vs Outcomes were measured at baseline and annually. 1.84; P = .0695) than Avonex. Numerically, long-term dis - Results: The 60 treatment and 63 control subjects were well ability absences were 1.89 days fewer for Copaxone matched for age, sex, race, marital status, and living situa - patients than for Avonex patients (4.62 vs. 6.51; P = .7853). tion. Minutes of strengthening/flexibility exercise per week in Conclusions: Among employees treated for MS, Avonex the treatment group increased from 33 ± 54 at baseline to

patients reported the least sick leave and fewest short-term Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 55.9 ± 83 at 1 year (paired t test, t = –1.876, P = .066) and disability absence days of the DMTs. These differences in 61 ± 70 at 2 years ( t = –2.048, P = .046). Exercise in the absence suggest that Avonex patients may have higher pro - control group was 30 ± 56 at baseline, 32 ± 53 at 1 year ductivity and lower disability than employees treated with (t = –0.247, P = .81), and 50 ± 94 at 2 years ( t = –1.742, other DMTs for MS. P = .087). The difference between the treatment and control Richard Brook*; Nathan L. Kleinman, PhD; Krithika Rajagopalan, PhD; groups was significant at 1 year ( P = .044) but not at base - Arthur K. Melkonian, MD line ( P = .63) or 2 years ( P = .63). No differences were found *The JeSTARx Group, Newfoundland, NJ, USA on the Modified Fatigue Impact Scale over the three measure - Study supported by Biogen Idec Pharmaceuticals, Cambridge, MA, USA. ments between the treatment group (9.48 ± 4.60, 8.96 ± 3.40, and 8.17 ± 3.90) and the controls (7.68 ± 7.40, P = (S07) Withdrawn .84; 8.07 ± 4.70, P = .26; and 8.35 ± 4.30, P = .83). Aver - age pain on a scale of 1–10 was similar in the groups: treat - (S08) Neuromyelitis Optica and Multiple Sclerosis ment, 3.16 ± 1.80, 3.41 ± 2.10, and 3.55 ± 1.60; control: in Sisters 3.26 ± 2.00 ( P = .84), 3.50 ± 1.50 ( P = .85), and 3.29 ± Background: Numerous familial cases of multiple sclerosis 2.30 ( P = .67). Also, no difference was found in depression (MS) have confirmed that hereditary factors are implicated in between the groups: treatment: 11.78 ± 8.70, 6.64 ± its pathogenesis. For neuromyelitis optica (NMO), five famil - 23.90, and 10.21 ± 9.10; control: 6.87 ± 22.90 ( P = .12), ial cases have been observed. Association of familial NMO 10.53 ± 10.40 ( P = .26), and 8.67 ± 7.70 ( P = .36). and MS have been reported, but the clinical details of the Conclusions: Motivational interviewing increased the cases were not described. Objective: Describe familial amount of strengthening/flexibility exercise at 2 years. This NMO and MS in sisters. Results: Patient 1 was a 41-year- did not lead to changes in fatigue, pain, or depression, old white woman who developed a left hemiparesis at age which may require more targeted or intensive exercise 24 years. She presented two new relapses of optic neuritis interventions. (ON) and . MS diagnosis was confirmed. The Expand - James Bowen, MD; K. Madrone; K. Wight; R.V. Wadhwani; C.H. Bombardier; ed Disability Status Scale (EDSS) score was 6.0. Serological D.M. Ehde; G.H. Kraft tests for viruses/non-organ-specific tests and NMO IgG anti - MS Center at Evergreen, Kirkland, WA, USA body were negative. Cerebrospinal fluid (CSF) study showed an increase in IgG. Magnetic resonance imaging (MRI) find - (S06) Impact of Multiple Sclerosis on Absenteeism ings fulfilled Barkhof et al. criteria for MS. Patient 2 was a Background: Several disease-modifying therapies (DMTs) 35-year-old white woman and patient 1’s sister. At age 28 are available for the treatment of multiple sclerosis (MS). years, the disease started with an episode of complete tho - Although efficacy data on the DMTs exist, limited compara - racic transverse myelitis (TM). She had many TM relapses tive data on absenteeism are available among employed and three ON episodes. The CSF study was normal. EDSS individuals with MS. Objective: Assess the differences in score was 8.5. CSF analysis showed an increase in IgG. lost time among MS employees treated with DMTs. Meth - Serological tests for viruses/non-organ-specific tests were nor - ods: A health care claims database of US employees from mal. Seropositivity for NMO IgG was detected. Brain/spinal 2001 to 2007 was used to analyze absenteeism. Patients cord MRI was compatible with NMO findings and did not ful - with MS (ICD-9 code = 340.XX) were identified, assigned to fill Barkhof et al. MS criteria. Discussion: In this study, we therapy cohorts based on prescription claims, and followed described the familial association of NMO and MS in two for 1 year after their initial prescription. MS employees who white sisters. The diagnosis of MS was confirmed clinically did not use DMTs were excluded. Two-part regression model - and by MRI, as well as the second case who completed the ing was used to determine the annual lost time (in days) for revised diagnostic criteria of NMO. Conclusions: The each cohort while controlling for age, sex, exempt status, full- description of these sisters suggests a stronger genetic rela - time/part-time status, salary, and Charlson Comorbidity tionship between these diseases. Further studies in familial Index. Results: Data from 273 employees with absence cases are necessary to know more about the genetic linkage data ( n =139, intramuscular interferon β-1a [IFN β-1a; between NMO and MS. Avonex]; n = 49, IFN β-1b [Betaseron]; n = 74, glatiramer Jose Antonio Cabrera Gomez, MD, PhD, FAAN*; L Ramón-Pérez, MD acetate [Copaxone]; and n = 11, subcutaneous IFN β-1a *International Neurological Restoration Center, Havana, Cuba

International Journal of MS Care 11 Posters

(S09) Intensive Neurorehabilitation Program With A continuous-use (CU) cohort ( n = 410) was created where Multidisciplinary Team for People With Multiple individuals were required to have used the medication of Sclerosis: Phase 2 Clinical Trial interest within 28 days of the end of the 2-year postperiod. Multivariate regression analyses were used to examine the Background: Disease-modifying therapies have not elimi - association between use of each DMD and 2-year total direct nated the need for neurorehabilitation in multiple sclerosis medical costs or relapse. Relapse was defined as being hos - (MS). Objective: Evaluate the efficacy of an intensive neu - pitalized with a diagnosis of MS or having an outpatient visit rorehabilitation program. Design/Methods: Thirty MS with a diagnosis of MS followed by a prescription for steroids (McDonald et al.) patients received an intensive neurorehabil - within a 7-day period. All analyses controlled for a wide itation program 6 hours daily for 4 weeks. Each patient had range of factors that may potentially affect outcomes. a one-on-one single physiotherapist, occupational therapist, Results: In the ITT cohort, compared with those who initiated and speech-language therapist. The evaluations were per - β formed by a laboratory team that did not participate in the therapy on HD-IFN -1a, patients who initiated therapy on GA neurorehabilitation by Scripps Neurological Rating Scale had a significantly lower risk of relapse (odds ratio = 0.543; (SNRS)/Expanded Disability Status Scale (EDSS), Ambulatory P = .0305) and significantly lower 2-year total direct medical Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Index, 9-hole peg test, PASAT-3, Fatigue Impact Scale (FIS), costs ($41,786 vs $49,030 ; P = .0002). In the CU cohort, β environmental status scale, and Quality-of-Life Scale (MSQLI- compared with those who used HD-IFN -1a, patients who 54). Results: Thirty MS patients ( n = 22 progressive, 8 used GA also had a significantly lower risk of relapse (odds relapsing), 19 women and 11 men, mean age 40.43 ± ratio = 0.213; P = .0049) and significantly lower 2-year total 11.46 years, 13.40 ± 7.76 years of evolution, completed the medical costs ($45,213 vs $57,311; P < .0001). Conclu - program. The evaluation of impairment/disability revealed sions: Results from this study indicate that compared with β SNRS initial mean 53.00 (standard deviation 14.83)/final HD-IFN -1a, use of GA is associated with significantly lower 68.08 (16.49) ( P = .000); EDSS, initial 5.80 (1.51)/final odds of relapse and significantly lower total direct medical 5.08 (2.10) ( P = .0001). Functional systems demonstrated costs. These results are more pronounced among CU patients. the following findings: in pyramidal, initial 3.97/final 3.15 Jane Castelli-Haley, MBA*; MerriKay Oleen-Burkey, PhD; Maureen Lage, PhD (P = .001); cerebellar, initial 257/final ( P = .000); brain *Teva Neuroscience, Kansas City, MO, USA stem, initial 1.57/final 0.78 ( P = .001); sensorial, initial Study supported by Teva Neuroscience. 1.40/final ( P = .023); bowel and bladder, initial 1.53/final (S11) Impact on Outcomes of Varying Medication 0.44 ( P = .000); visual, initial 0.70/final 0.48 (NS); cere - Possession Ratios for Glatiramer Acetate bral, initial 0.47/final 0.23 (NS). Others findings included spasticity, initial 1.07/final 0.38 ( P = .000); ambulatory, ini - Objective: Compare how changes in the medication posses - tial 27.40 (28.54)/final 23.95 (24.82) ( P = .393); 9-hole sion ratio (MPR) affect patient outcomes among multiple scle - peg test dominant hand, initial 3138 (8.26)/final 2754 rosis (MS) patients treated with glatiramer acetate (GA; (6.71) ( P = .008), nondominant hand, initial 38.01 (16.92) / Copaxone). Methods: Data were obtained from i3’s Lab Rx final 30.39 (8.17) ( P = .014); PASAT-3, initial 21.14 Database from September 2001 to June 2006. Patients were (18.36)/final 29.29 (22.21) ( P = .018); environmental status included if they were diagnosed with MS, initiated therapy scale, initial 17.06 (8.40)/final 16.53 (9.05) (NS). There with GA, and had continuous insurance coverage from 6 was reduction in fatigue, initial 47.18 (15.01)/final 30.58 months before through 24 months after initial use of GA ( N = (18.28) ( P = .005). MSQLI-54 demonstrated an improvement 872). Multivariate regressions examined the association in physical health, initial 46.11 (12.32)/final 57.32 (14.37) between use of achievement of alternative MPR goals and 2- (P = .008), and in mental health, initial 51.64 (21.65)/final year total direct medical costs or relapse, where relapse was 62.46 (20.50) ( P = .026). Conclusions: An intensive one- defined as being hospitalized with a diagnosis of MS or an on-one neurorehabilitation program demonstrated in 4 weeks outpatient visit with a diagnosis of MS followed by a prescrip - an improvement of impairment, disability, fatigue and quality tion for steroids within a 7-day period. Regressions also con - of life in people with MS not reached by any of the disease- trolled for differences in patient characteristics. Results: For modifying therapies. patients who initiated therapy on GA, increases in MPR were Jose A. Cabrera-Gomez, MD, PhD, FAAN; Y. Real-González, Lic; associated with significantly lower odds of relapse. Specific - R. Díaz-Marquez, Lic ally, patients who achieved MPR of at least 0.7, 0.8., or 0.9 International Neurological Restoration Center, Havana, Cuba had odds ratios of relapse of 0.583, 0.530, and 0.437, respectively ( P < .05). Furthermore, although the use of med - (S10) Comparing Patient Outcome With Glatiramer ications (eg, GA) to treat MS resulted in higher total direct Acetate or High-Dose Interferon β-1a medical costs, the marginal impact of medication use on total Objective: Compare outcome among multiple sclerosis (MS) direct medical costs decreased as MPR increased. For exam - patients treated with either glatiramer acetate (GA) or high- ple, a patient with MPR ≥0.5 had increased costs of dose interferon β-1a (HD-IFN β-1a). Methods: Data from $22,288 ( P < .0001), whereas those with MPR ≥0.9 had September 2001 to June 2006 were obtained from i3’s Lab increased costs of $11,707 ( P < .0001). Conclusions: Rx database. An intent-to-treat (ITT) cohort ( n = 845) was cre - Increases in MPR for GA are associated with reductions in the ated of patients diagnosed with MS who initiated therapy on patients’ marginal costs of medical treatment. This result sug - one of two disease-modifying drugs (DMDs), either GA or gests that despite the higher costs associated with increased HD-IFN β-1a, and had continuous insurance coverage from 6 use of GA, cost offsets exist that are associated with compli - months before through 24 months after medication initiation. ant use of the medication. Furthermore, results from this study

International Journal of MS Care 12 Posters indicate that a higher MPR for GA is associated with signifi - β-1a and GA in 50% and single agent/corresponding place - cant reductions in the probability of relapse. bo in 25% (1000 subjects). Methods: In August 2007, sub - Jane Castelli-Haley, MBA*; MerriKay Oleen-Burkey, PhD; Maureen Lage, PhD jects were asked to complete an additional trial referral ques - *Teva Neuroscience, Kansas City, MO, USA tionnaire. Eligibility data are captured on all screened Study supported by Teva Neuroscience. subjects. Results: By January 2008, 51% completed referral questions (386 of 758). Most referrals were physician relat - (S12) BaroFeron: More Bioavailable and Less ed: 63% already being treated by a CombiRx physician, Immunogenic Interferon- β Product 29% referred by their neurologist to a CombiRx physician. BaroFeron consists of recombinant human interferon β-1 b Another 9% were referred by clinic staff (4%); another physi - (rhIFN β-1 b) produced with PreEMT technology, which reduces cian (1%); www.nmss.org (1%); www.mayo.edu (1%); or or eliminates aggregates. Protein aggregates in cur - www.clinicaltrials.gov, friend/patient, in-clinic advertising, or rent IFN β products may cause the formation of neutralizing other (<1% each). CombiRx has randomized 90% of in multiple sclerosis (MS) patients and reduce screened subjects. Initially, 128 subjects failed the multistage bioavailability. Sprague Dawley rats, cynomolgus monkeys, screening. Of these, 36% resolved exclusions and were Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 and rhesus monkeys (4 males/group) were administered rescreened and randomized; 64% were terminal failures. BaroFeron, a commercial rhIFN β-1 b product, or a commer - Reasons for rescreened patient initial failure were: not being cial rhIFN β-1 a product (0.20 mg/kg in rats; 0.05 mg/kg in neurologically stable at 30 days (30%), abnormal labs or monkeys). Plasma levels of IFN β were measured by enzyme- exceeded screening period (17% each), <2 exacerbations in linked immunosorbent assay (ELISA), and neopterin responses 3 years (5%), other reasons <1% each. Reasons for terminal in monkeys were detected with an ELISA kit. Pharmokinetic failure were protocol exclusion (47.5%), nonprotocol exclu - parameters were determined with noncompartmental analy - sion deemed inappropriate for trial (10%), eligible but sis. Immunogenicity was assessed in two mouse models. declined (6%), lack of follow-up (5%), insufficient data (4%), Murine IFN β (mIFN β) before and after PreEMT treatment was and 27.5% eligible not randomized without reason for termi - administered to mice. Transgenic mice overexpressing human nation. Conclusions: CombiRx recruitment is largely due to IFN β were administered BaroFeron or a commercial rhIFN β dedicated participating centers. ClinicalTrials.gov has not yet product. An anti-IFN β ELISA was run at the end of each study been a valuable tool, yielding one referral. CombiRx is not to assess immunogenicity. In both rats and cynomolgus mon - tracking sources of “other physician” referrals and cannot keys, BaroFeron administered subcutaneously had a signi- determine how non-CombiRx physicians heard about the ficantly greater bioavailability (4-fold in rats, 10-fold in study. Word of mouth, which is difficult to capitalize on, has monkeys) than commercial rhIFN β-1 b at the same dose. Baro - also been an important recruitment tool in CombiRx. Feron had a greater-than-expected terminal half-life (25.55 ± Stacey Cofield, PhD*; Tarah Herrmann; Robin Conwit; Gary Cutter; 12.50 h) in cynomolgus monkeys after subcutaneous adminis - Jerry Wolinsky; Fred Lublin tration. The same dose of BaroFeron or commercial rhIFN β- *University of Alabama at Birmingham, Birmingham, AL, USA 1a administered intramuscularly had comparable bioavail - Study supported by the National Institutes of Health/National Institute ability. Rhesus monkeys had comparable pharmacokinetic of Neurological Disorders and Stroke 1 U01 NS 45719-01 A.1. and pharmacodynamic profiles to cynomolgus monkeys. Pre - EMT treatment of mIFN β reduced its immunogenicity com - (S14) Multiple Sclerosis and Oromandibular pared with untreated or aggregated mIFN β. An ongoing Dystonia: Case Report and Literature Review study in transgenic mice treated with BaroFeron or commer - Oromandibular dystonia (OMD) is defined as involuntary β cial rhIFN will be reported. Overall, BaroFeron manufac - spasms of masticatory, lingual, and pharyngeal muscles, tured with PreEMT technology has reduced immunogenicity resulting in jaw closing, jaw opening, jaw deviation, or a and increased bioavailability compared with commercial combination of these movements. Although dystonia has been β rhIFN -1 b. BaroFeron may reduce or eliminate neutralizing occasionally reported in association with multiple sclerosis antibody formation in patients and provide greater efficacy at (MS), OMD has not previously been described. A 35-year-old β a lower dose than commercial rhIFN -1 b. man with a history of relapsing-remitting MS diagnosed in Jeffrey Cleland, PhD*; M. Rosendahl; S.P. Eisenberg; M. Seefeldt; D. Haughey 2004 was referred to us for evaluation of OMD. His magnet - *BaroFold, Inc., Redwood City, CA, USA ic resonance imaging scan was remarkable for multiple sub - Study supported by BaroFold, Inc. cortical white matter lesions with sparing of both striatal regions. The patient had a 16-month history of OMD requir - (S13) Recruitment, Screening, and Retention to ing frequent emergency room visits, during which he required Randomization in CombiRx Trial propofol infusions for relaxation of his jaw. The patient Background: Recruitment is often the major delaying factor received a botulinum toxin (BTX) injection, which led to com - to trial completion. Common methods are physician, staff, plete resolution of his symptoms for 3 months, but subsequent and patient referrals; in-clinic and media advertising; mass injections were not beneficial. Tremor and paroxysmal dysto - mailings; and the Internet. ClincialTrials.gov, launched in nia have been reported in patients with MS. Other movement 2000, is required for National Institutes of Health studies. disorders such as blepharospasm, spasmodic torticollis, Screening subjects is a key first step, but the ultimate goal is writer’s cramp, generalized dystonia, and myoclonus have randomization. Objective: Study recruitment and enrollment been described but more rarely. Two cases of paroxysmal in relapsing-remitting multiple sclerosis patients in CombiRx, a OMD in the setting of MS are present in the literature. One multicenter randomized clinical trial of combination interferon involved a 28-year-old woman with difficulty closing the left

International Journal of MS Care 13 Posters eye and deviation of the mouth to the left, resolving over sev - (S16) Safety of Parenteral Repeat eral weeks. The other was a 50-year-old woman with episod - Treatment in Multiple Sclerosis Clinical Trials ic bucco-linguofacial dystonia lasting 20–30 seconds. No Background: Cladribine induces sustained, selective lym - instances of OMD in association with MS as described in our phocyte depletion, allowing for administration in short-course patient exist in the literature. Recognizing dystonia in the MS treatment periods, and has shown promise in clinical trials in patient is essential given the existence of viable treatment relapsing multiple sclerosis (MS). Parenteral cladribine options. Medical options include anticholinergics, benzo- appeared to be generally well tolerated, with a good safety diazepines, carbamazepine, and carbidopa/levodopa. How - profile at cumulative doses of <2.8 mg/kg in four random - ever, BTX has been shown to be the optimal treatment. Our ized, placebo-controlled trials and one open-label pilot study patient’s initial response to BTX suggests this treatment is in relapsing MS. Objective: Assess the safety and tolerabili - effective, but it clearly requires exquisite placement of the ty of repeat treatment with parenteral cladribine in patients drug. with MS. Design/Methods: Combined safety data from patients who received ≥2 courses of cladribine (cumulative Devon Conway, MD*; Alexander Rae-Grant, MD dose per course: 0.70–3.65 mg/kg) in these trials were ana - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 *Case Western Reserve University, Lyndhurst, OH USA lyzed. Because of differences in follow-up durations, treat - ment-emergent adverse events (TEAEs) occurring in months 0– (S15) Patients Free From Disease Activity With 12 of the first treatment period (TP1; first dose to second Betaseron or Copaxone Treatment course) and second treatment period (TP2; first dose of sec - Objective: Investigate the number of patients with relapsing- ond course to last available assessment) were compared . ≥ remitting multiple sclerosis (RRMS) who were free from Results: Overall, 78 patients received 2 courses of cladrib - relapse, magnetic resonance imaging (MRI) activity, and dis - ine. In TP1 and TP2, the mean cladribine dose was 1.60 and ability progression over ≥104 weeks while treated with inter - 1.48 mg/kg, and the mean duration of follow-up was 29.4 and 13.5 months, respectively. Cladribine was generally well feron β-1b (IFN β-1b; Betaseron) 500 µg, IFN β-1b 250 µg, or tolerated. The incidences of the 10 most common TEAEs were glatiramer acetate (GA; Copaxone). Background: The similar during months 0–12 of TP1 and TP2: fatigue (33 and Betaferon/Betaseron Efficacy Yielding Outcomes of a New 15%, respectively), headache (32 and 19%), upper respira - Dose (BEYOND) study examined the safety, tolerability, and tory tract infection (29 and 15%), injury (23 and 10%), nau - β µ β µ efficacy of subcutaneous IFN -1b 500 g, IFN -1b 250 g, sea (22 and 10%), injection-site reaction (21 and 37%), uri - or GA in the treatment of RRMS. Methods: RRMS patients nary tract infection (21 and 17%), injection-site pain (18 and ≤ with Expanded Disability Status Scale (EDSS) scores 5.0 14%), purpura (18 and 12%), and depression (15 and were randomized in a 2:2:1 ratio to subcutaneous IFN β-1b 10%). Conclusion/Discussion: These preliminary data on 500 or 250 µg every other day or GA 20 mg daily for ≥104 a few patients suggest that cladribine was generally well tol - weeks. The primary efficacy variable was relapse risk; other erated, with a safety profile that was maintained or improved predefined endpoints included proportion of patients free with repeated exposure. Injection-site reactions will be avoid - from relapse, new MRI lesions, and EDSS progression. ed with the use of the new oral tablet formulation of cladrib - Results: A total of 2244 patients from 196 centers world - ine, which is currently being assessed in MS. wide were allocated to IFN β-1b 500 µg ( n = 899), IFN β-1b Stuart Cook 250 µg ( n = 897), or GA ( n = 448). Mean EDSS scores at New Jersey Medical School, Newark, NJ, USA baseline and mean number of relapses in the year before (S17) Choosing Therapy for Multiple Sclerosis: study were low and comparable in all groups. No significant Whose Decision Is It? differences were found among the three groups for the pri - mary endpoint. The proportion of patients from each treat - Background: Several disease-modifying therapies (DMTs) ment arm who were free from relapse, new MRI lesions, and are available for the treatment of relapsing multiple sclerosis confirmed EDSS progression (defined as ≥1-point increase (MS). DMTs differ in aspects that may impact patient lifestyle from baseline, confirmed 3 months later) are presented. Con - and potentially influence treatment satisfaction and adher - clusions: Contemporary MS therapy trials have recruited ence. Objective: Explore how decisions regarding treatment patient populations at an earlier stage of the disease than his - initiation for MS are made, and identify methods for improv - torical studies. This study population had the typical low bur - ing this process from the patient’s perspective. Design/ den of disease seen in such early-stage patients. All treatment Methods: Data were derived from polls of MS ambassadors groups maintained low levels of disease activity throughout taken during an MS Lifelines summit held in August 2007. β the study, with substantial proportions of patients remaining MS ambassadors are patients receiving interferon -1a subcu - β free from any disease activity. The data provide useful infor - taneously (IFN -1a SC) who provide guidance and support to mation in planning future clinical trials in RRMS. other MS patients through MS LifeLines, an educational patient support program. Results: Thirty-three percent of Stuart Cook*; Barry G.W. Arnason; Giancarlo Comi; Massimo Filippi; Douglas S. Goodin; Hans-Peter Hartung; Douglas R. Jeffery; Ludwig Kappos; patients (13 of 39) reported that their decision to initiate Paul O’Connor; Timon Bogumil; Brigitte Stemper; Vitali Filipov; Maria Groth; IFN β-1a SC was based on a recommendation from their Francis Boateng health care provider (HCP). However, 51% of patients made *UMD New Jersey Medical School, Newark, NJ, USA the treatment decision themselves, either through the informa - Study supported by Bayer Schering Pharma AG, Berlin, Germany. tional materials provided by the manufacturer (13 of 39) or

International Journal of MS Care 14 Posters from their own independent research (7 of 39). Forty-one per - tics to what has been reported for other large, nonveteran cent of patients (21 of 51) reported being very involved or MS cohorts. These results suggest that findings from the the sole decision maker in the process. For the remaining MSSR cohort will have applicability to the general MS patients, 37% made the decision in partnership with their patient population. HCP, 18% accepted their physician’s recommendation, and William Culpepper, MA*; Douglas Bradham, DrPH; Christopher Bever, MD; 4% were told what treatment to take. According to patients, Dennis Bourdette, MD decisions to change therapy were primarily initiated by the *MS Center of Excellence–East, Baltimore, MD, USA patient (67%; 20 of 30) rather than the physician (33%; 10 Study supported by a research grant from Bayer Pharmaceuticals, Inc. of 30). Patients unanimously felt a need for up-to-date unbi - (formerly Berlex Laboratories). ased information about MS and medications with which to (S19) Adherence Measures and Relapse make informed decisions and desired greater input and Prevention in Multiple Sclerosis advice from their physicians. Conclusion/Discussion: Patients appeared to want a mixture of independence and Background: Medication adherence is an essential compo - support from HCPs in choosing treatment, desiring both con - nent of multiple sclerosis (MS) therapy and may help to pre - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 trol over the decision and greater physician involvement. vent relapses. Objective: Examine the relationship among Improving the process of choosing therapy through a strong three measures of medication adherence for MS drug ther - patient-HCP partnership, including patient access to reliable apy and the likelihood of experiencing a severe relapse. drug information, should meet patient expectations and there - Design/Methods: Subjects were selected from the PHAR - by help to maintain treatment adherence and satisfaction. Metrics database (Watertown, MA, USA) if they were taking one or more MS drugs (Avonex, Betaseron, Copaxone, Rebif) Kathleen Costello, MS, CRNP*; Jo Scanzillo, RN, MSCN; Susan Hundley, RN, BSN, MSCM; Patricia Kennedy, RN, CNP claims from 1 January 2000 through 31 December 2004 and were continuously eligible for 24 months after their first *Maryland Center for Multiple Sclerosis, Baltimore, MD, USA MS-related prescription (index date) and 6 months before the Study supported by EMD Serono, Inc., and Pfizer Inc. index date. Subjects had to be 18–65 years of age and were (S18) Epidemiologic Description of VA Multiple excluded if they were exposed to Tysabri after the index date, Sclerosis Surveillance Registry had study medication use in a health care facility, or were admitted to a long-term care facility. Severe MS relapse was Background/Objectives: Veterans Affairs (VA) has one of defined as an MS-related hospitalization or emergency room the largest populations of multiple sclerosis (MS) patients, but visit. Medication adherence was measured by three methods: because of lack of detail in VA extant data, case ascertain - medication possession ratio (MPR), consistence, and persist - ment and epidemiologic research has been limited. We ence. Age, sex, geographic region, treatment status, comor - developed an algorithm that correctly classified MS in 93% of bidities, and use of mono- or multidrug therapy were study patients and conducted a mail-based survey to collect addi - covariates. Results: Subjects ( N = 2388) had an average tional data and enroll veterans into the MS Surveillance age of 43.9 years, 76.4% were women, 76.7% were new Registry (MSSR). The intent of this report is to assess how patients, and 8.1% had one or more severe MS relapses. All representative the MSSR is of the general MS population. three adherence measures were significantly associated with Methods: We surveyed all female veterans and a stratified severe MS relapse. Odds ratios were 0.921 for MPR, 0.946 random sample of male veterans by region ( N = 3905, 35% for persistence, and 0.895 for consistence, indicating an association between increased adherence and decreased of the MS patient cohort). The survey consisted of three mail - likelihood of severe MS relapse. Only comorbidity and ings at 5-week intervals. The survey collected self-reported region (East) were significant ( P < .05) for predicting likeli - subtype and other clinical data, MS symptoms (MSS), activi - hood of a relapse. Conclusion/Discussion: Findings from ties of daily living, Patient-Determined Disease Steps (PDDS: this analysis indicate that the relationship between MS-related disability), MS quality of life (QOL), and use of disease- treatment adherence and the reduced likelihood of a severe modifying therapy (DMT). This report describes preliminary MS relapse is consistently supported by MPR, consistence, results through the first two mailings. Results: A total of and persistence. These results are consistent with previously 1228 people (31% of the sample) responded: 7% declined, reported findings on maximum gap in drug therapy and likeli - 2% had died, 1% did not have MS, and 2% had incorrect hood of a severe MS relapse. address or were unable to complete the survey. Respondents Michael Dickson, PhD*; Chris Kozma, MD; Darin T. Okuda, MD, MSc; were 48% women and had mean age 55.0 (±9.6) years; Contessa Fincher, PhD, MPH; Dennis Meletiche, PharmD 83% were white; 50% had relapsing-remitting MS (RRMS), *University of South Carolina, Columbia, SC, USA 33% had secondary progressive MS (SPMS), 13% primary Study supported by EMD Serono, Inc., and Pfizer Inc. progressive MS, and 4% progressive relapsing MS. Mean age at onset was 34.0 (±10.4) years, age at diagnosis was (S20) Complete Clinical and Magnetic Resonance 38.0 (±9.9) years, mean duration of MS was 15.0 (±9.7) Imaging Response in Multiple Sclerosis: years, and the median PDDS was 5 (cane for 25+ ft walk). At Effect of Natalizumab least one DMT had been prescribed in 86% (518) of RRMS Background: Patients receiving traditional multiple sclerosis and 89% (358) of SPMS patients. Conclusions: MSSR pro - (MS) disease-modifying therapies may continue to experience vides a nationally representative cohort of MS patients that is disease activity despite treatment. In phase 3 studies, natal - similar in demographic (except sex) and clinical characteris - izumab (Tysabri) reduced relapse rates by up to 68% and the

International Journal of MS Care 15 Posters risk of disability progression by up to 54%. To begin to edge, problem-solving and communication strategies, dealing explore the possibility of an ultimate treatment goal of com - with emotional issues, providing physical care, finding and plete response, the ability of natalizumab to increase the pro - using community resources, and planning the future. Focus portion of patients free of clinical and magnetic resonance groups obtained feedback from participants on completion of imaging (MRI) disease activity was assessed. Methods: the program. Results: After significant recruitment chal - Patients in the AFFIRM (natalizumab monotherapy vs place - lenges, a total of 19 caregivers completed the program. bo) and SENTINEL (natalizumab + interferon β-1a vs interfer - Quantitative analyses did not support increased self-efficacy on β-1a alone) studies were evaluated for clinical and MRI for problem-solving or greater health-promotion strategy use. disease activity. Absence of disease activity was defined by Caregivers did show improvement in their ability to prepare clinical criteria (no relapses or disability progression sus - for and manage caregiving challenges through three of five tained for 12 weeks), MRI criteria (no gadolinium-enhancing subscales of the Coping With Multiple Sclerosis Caregiving or new/enlarging T2-hyperintense lesions), and a more strin - Inventory (avoidance, P = .032; practical assistance, P = gent combination of clinical and MRI criteria. A subgroup .033; and positive reframing, P = .005). Qualitative feed - ≥ analysis of patients with highly active (ie, 2 relapses in the back from participants indicated that the program provided Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 year before study entry and ≥1 baseline gadolinium-enhanc - useful information, peer support, and opportunities for skill ing lesion) and non–highly active disease was performed. development. Suggestions for program refinement were Results: Significantly more natalizumab-treated patients offered. Discussion/Conclusion: The Meeting the Chal - were free of disease activity over 2 years than placebo lenges of MS program for caregivers appears to be worth patients on clinical (AFFIRM: 64.3 vs 38.9%; SENTINEL: pursuing given the current findings. Challenges of recruitment 47.4 vs 28.0%), MRI (AFFIRM: 57.7 vs 14.2%; SENTINEL: will need to be overcome to move the work forward. 65.5 vs 27.6%), and combined clinical and MRI (AFFIRM: Marcia Finlayson, PhD, OT(C), OTR/L; Katharine Preissner, MHE, OTR/L 36.7 vs 7.2%; SENTINEL: 31.7 vs 10.9%) measures (all com - University of Illinois at Chicago, Chicago, IL, USA parisons P < .0001). Similar results were observed in highly Study supported by the National Multiple Sclerosis Society and the Mid - active and non–highly active subgroups (all P < .005). west Roybal Center for Health Promotion and Behavior Change. Conclusions: Natalizumab significantly increased the pro - portion of patients free of clinical and MRI disease activity (S22) Immunologic Markers in Multiple Sclerosis over 2 years compared with placebo regardless of baseline Patients on Mycophenolate Mofetil disease activity. Incorporation of endpoints assessing com - Background: In individuals on monotherapy with interferon plete clinical and MRI response into clinical studies of MS β (INF β) or glatiramer acetate (GA) compared with untreated therapies such as natalizumab should be considered, parallel - multiple sclerosis (MS) patients, mean peripheral blood (PB) ing trends in studies of other immune-mediated disorders. cell count of CD3+, CD4+, and CD8+ T cells and CD19+ B Eric Eggenberger, DO*; Peter A. Calabresi, MD; Christian Confavreux, MD; cells remains undepleted. Objectives: Determine the effect Steven Galetta, MD; Gavin Giovannoni, MBBCh, PhD; Eva Havrdova, MD; Michael Hutchinson, MD; Ludwig Kappos, MD; Fred D. Lublin; David H. Miller, of continuous combination therapy (CCT) in MS patients MD; Paul W. O’Connor, MD; J. Theodore Phillips, MD, PhD; Chris H. Polman, using INF β-1a intramuscularly, a daily physiological dose of MD, PhD; Ernst-Wilhelm Radue, MD; Richard A. Rudick, MD; William Stuart, prednisone, and mycophenolate mofetil (CellCept) 2 g/day MD; Andrzej Wajgt, MD on immunologic markers (IMs). Materials/Methods: The *Department of Neurology and Ophthalmology, Michigan State University, East cell count of PB immunocompetent cells and serum level of Lansing, MI, USA cytokines were monitored for 24 months in 16 female and 9 Study supported by Biogen Idec, Inc., and Elan Pharmaceuticals, Inc. male patients with MS on CCT with CellCept. Mean Expand - ed Disability Status Scale (EDSS) rating remained unchanged (S21) Meeting the Challenges of MS: Outcomes of (4.40 ± 1.72 to 4.40 ± 2.11 ; P = 1.000). Enhancing lesions a Caregiver Education Pilot Study on magnetic resonance imaging of the head in four patients Background: Caregiving can be a challenging role that were seen only in one individual by the end of the second negatively influences the health of both caregiver and care year presenting with EDSS improved by 2.5 points. No side recipient. Objective: Pilot test a group-based psychoeduca - effects requiring discontinuation of treatment, including oppor - tional and problem-solving program for older caregivers of tunistic infections, were recorded. Results: In patients on people with multiple sclerosis (MS) called Meeting the Chal - CCT compared with untreated individuals with MS ( n = 20), lenges of MS. Design/Methods: A pre-/postintervention decreased PB cell count (per µL) of CD3+ cells (993.33 ± design followed by participant focus groups was used to 661.83; P = .0071) and CD19+ B cells (80.56 ± 81.78; determine whether the program positively influenced care - P = .0006) and trend toward depletion in CD8+ T cells givers’ self-efficacy for solving the challenges of MS-related (286.80 ± 176.40; P = .0480) was established. Compared caregiving, strengthened their ability to prepare for and man - with untreated patients, normal range in lymphocyte count age caregiving challenges, and increased their ability to (>1.500 µL) and CD3+, CD4+, CD8+, and CD19+ cell monitor and implement personal health-promoting strategies. count in 40, 40, 44, 52, and 44% of the patients treated, Caregivers were recruited through a range of advertising respectively, was recorded. During the second year, the most strategies. Eligible caregivers were ≥50 years of age, provid - pronounced decrease in serum level of sIL2R (1697.47 ± ed ≥45 minutes of unpaid care per day, and reported difficul - 387.20 to 1339.86 ± 351.27 pg/ml; P < .0001), decreas - ty engaging in personal health-promoting activities secondary ing concentration of IL-12, particularly between months 18 to caregiving. The five-session program was delivered by a and 24 (63.14 ± 99.16 to 28.43 ± 52.35 pg/ml; P = licensed occupational therapist. Topics included MS knowl - .0038), and trend toward downregulation of tumor necrosis

International Journal of MS Care 16 Posters factor α (P = .0639) were noticed. No correlations between placebo ( n = 54); most patients completed all scheduled the IM recorded were established. Conclusions: With the courses of therapy. CD3+ (T cell), CD4+ (helper T cell), CD8+ known potential role of CD4+/CD8+ T cells and CD19+ B (cytotoxic T cell), CD19+ (B cell), and CD16+/CD56+ (natur - cells in progressive MS, monitoring of IMs in individual al killer cell) cell counts were measured at baseline and patients may be helpful in early detection of nonresponders to monthly for 1 year. Results: Cladribine was associated with the ongoing therapy. a pronounced, sustained, dose-dependent reduction in the Margaret Frazer, MD*; Jian Hong, MD, PhD; Younghao, MA, MD, PhD; mean CD4+ T-cell count from baseline to final evaluation. Oldrich J. Kolar, MD, PhD; Heidi Lee, MD; Karen D. Rodman, MD; More patients receiving cladribine 2.1 mg/kg had CD4+ cell Y.C.Q. Zang, MD, PhD counts of ≤0.20 x 10 9/L ( n = 31) than those receiving *Indiana Center for MS, Indianapolis, IN, USA cladribine 0.7 mg/kg ( n = 5) or placebo ( n = 1). Notably, Study supported by a grant from Aspreva Pharmaceuticals, Inc. two patients receiving cladribine 2.1-mg/kg treatment had at least one CD4+ cell count of ≤0.05 x 10 9/L. A dose-depen - (S23) Epidemiology of Multiple Sclerosis and dent reduction in the mean CD4:CD8 ratio was seen in Nutrition, Medical History, and Lifestyle

patients receiving cladribine but not in patients receiving Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Background: The etiology of multiple sclerosis (MS) placebo. Mean CD19+ and CD16+/CD56+ cell counts remains poorly understood. Nutrition and certain food pat - decreased during the first 2–7 months of cladribine treatment terns may play a role in the etiology of MS. Dental amalgams but recovered after 10 and 7 months, respectively. Conclu - containing mercury have recently been suggested as a possi - sion/Discussion: Cladribine causes a preferential and sus - ble risk factor for MS, and sociodemographic characteristics tained depletion of CD4+ T cells with an apparent relative also may play important roles in its development. Methods: sparing of other lymphocyte subsets, including B cells and In a case-control study of MS, a total of 200 newly diag - natural killer cells. These preliminary findings may explain the nosed MS patients and 202 frequency-, age-, and sex- therapeutic effect of cladribine in MS (MS-001: 87 and 92% matched population-based controls were studied. Results: reduction in gadolinium-enhancing lesion volume with 0.7 An inverse association was observed between high body and 2.1 mg/kg, respectively) and the relatively few serious mass index (BMI) and risk of MS (odds ratio [OR] = 0.76; infections reported in trials of parenteral cladribine at doses 95% confidence interval [CI], 0.61–0.95). A positive associa - ≤2.1 mg/kg in MS. tion was observed with total energy (OR = 2.03; 95% CI, Joseph Guarnaccia, MD*; Henry Rinder; Brian Smith 1.13–3.67) and animal fat intake (OR = 1.99; 95% CI, *Multiple Sclerosis Treatment Center at Griffin Hospital, Derby, CT, USA 1.12–3.54). A significant protective effect was observed with intake of vegetable protein (OR = 0.38), dietary fiber (S25) Multiple Sclerosis Fatigue and Sleep (OR = 0.54), vitamin C (OR = 0.58), thiamin (OR = 0.24), Disorders: Inteferon Effect riboflavin (OR = 0.33), calcium (OR = 0.34), and potassium Fatigue is common in patients with multiple sclerosis (MS). (OR = 0.29). A suggestive elevated risk was found for indi - Polysomnography (PSG) studies in patients with MS and viduals with many dental amalgams and for long periods. symptomatic fatigue have demonstrated undiagnosed sleep Smoking (OR = 1.6) and history of certain infectious diseases disorders of varying types. Disease-modifying therapies such as (OR = 2.5), mumps (OR = 1.8), and reportedly cause or aggravate MS fatigue. The interferon (OR = 1.7) significantly increase the risk of MS. We also effect in MS sleep disorders has not been previously investi - observed that having caged birds at home increases the risk gated . Objective: Compare sleep parameters in interferon- of MS (OR = 1.9), particularly among women (OR = 2.5). and non–interferon-treated MS patients who report sympto - Individuals with family history of MS had a 3.4 times higher matic fatigue with PSG. Methods: We prospectively used chance to develop this disease than individuals with no histo - PSG to investigate MS fatigue. MS patients who complained ry of MS. This study suggests that nutrition, lifestyle, history of of fatigue were referred for PSG. Disease-modifying agents certain infectious diseases, and family history of MS may were recorded. Results: Sleep abnormalities were common play important roles in the etiology of the disease. in both interferon- and non–interferon-treated MS patients Parviz Ghadirian, MD with fatigue. Sleep latency >60 minutes, sleep efficiency Research Centre Chum, Hotel-Diew, Montreal, QC, Canada >85%, time spent in REM sleep 17–28%, and time spent in stage 1/2 sleep 50–65% were the same in both groups. (S24) Preferential Depletion of Lymphocyte Patients treated with interferon had different sleep parameters Subpopulations by Cladribine than those treated with noninterferon therapies: REM latency Background: Cladribine is a preferential lymphocyte- >180 minutes (58 vs 32%), REM sleep <5% (18 vs 7%), depleting agent that is being investigated as a potential treat - arousal index >20/hour (47 vs 15%), and apnea-hypopnea ment for multiple sclerosis (MS). Its mechanism of action index >40 (2 vs 8%). MS patients with fatigue and body enables administration with a novel once-daily, short-course mass index <28 had different sleep parameters (interferon vs dosing regimen; an oral tablet formulation is in clinical devel - non–interferon treated): sleep efficiency >85 (40 vs 26%), opment. Objective: Investigate the effect of parenteral sleep latency <30 minutes (40 vs 65%), time spent in REM cladribine on lymphocyte subpopulations in a previously sleep <5% (15 vs 0%), time spent in stage 1/2 sleep 50– reported randomized, controlled, phase 3 trial in patients 65% (33 vs 13%), arousal index >20/hour (67 vs 26%), with primary or secondary progressive MS (MS-001). REM apnea-hypopnea index >20/hour (38 vs 18%). Dis - Design/Methods: Patients received parenteral cladribine cussion: Sleep abnormalities are common in MS patients (cumulative dose: 0.7 [ n = 53] or 2.1 [ n = 52] mg/kg) or with fatigue. Interferon therapy may contribute to MS fatigue

International Journal of MS Care 17 Posters by greater disruption of sleep architecture than seen in Acute hospital care is the primary medical cost driver for our fatigued MS patients treated with noninterferon therapy. The MS patients, accounting for 34% of total medical costs. mechanism of apparent interferon effect on sleep needs fur - Methods: We studied 12 months of claims data (service ther investigation. dates 1 February 2006 to 31 January 2007) for 32,675 Mark Gudesblatt, MD; Myassar Zarif, MD; Barbara Bumstead, ANP; people identified with MS (77% women and 23% men). Inpa - Lori Fafard, RN; Anne Dunne, RN; Steven Xian; Carol Seidel; Lourdes Cruz, tient and emergency room events that resulted in a same-day RN; Serina Fahey, RN; Joan Bohuslaw, RN; Chris Burke, RPT hospital admission were examined. To simplify analysis, pri - South Shore Neurologic Associates, Patchogue, NY, USA mary, secondary, and tertiary diagnosis codes were rolled into Clinical Classifications Software (CCS2) groupers. Con - (S26) Quality-of-Life Multiple Sclerosis Scale: clusions: Beyond MS, the most common reasons for hospi - Reliability and Validity talization (in order of prevalence) include diseases of the Goal: A goal of the International Organization of Multiple heart/hypertension, diseases of the urinary system (urinary Sclerosis Nurses (IOMSN) is to develop a self-assessment tool tract infections), lower respiratory illnesses (shortness of for multiple sclerosis (MS) patients and their families to self- breath, abnormal respiration, abnormal findings in lungs), Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 monitor their condition and evaluate outcomes of care. connective tissue disease (myalgia and myositis), spondylosis, Method: After a review of published quality-of-life (QOL) gastrointestinal disorders (dysphagia, constipation, diarrhea), scales by an IOMSN committee, the 13-item QOL-AD scale joint disorders (osteoarthritis, rheumatoid arthritis), and bacte - used with patients diagnosed with Alzheimer’s disease was rial infection (septicemia). Education around the prevention selected for modification, together with the development of and management of these comorbidities may improve the 10 additional items specific to MS patient health. The result - quality of life for patients and reduce hospital admissions ing 23-item QOL-MS scale, which used a 4-point Likert scale, related to these conditions. Further analysis was performed was piloted on 91 patients diagnosed with relapsing-remitting for each condition to determine when hospitalization preva - (n = 63) and progressive ( n = 28) MS from across the United lence rates escalate to a level warranting increased interven - States. Of these, 61 were women and 30 were men. Internal tion. For example, for individuals aged 30–39 years with an consistency reliability of the QOL-MS was conducted and inpatient admit, 22% of these events were related to heart construct validity by correlating scores between the QOL-MS disease. Notably, cardiovascular-related admits nearly dou - and MSQOL-54 scale. Results: Internal consistency of the ble to 40% for individuals aged 40–49 years. This type of total QOL-MS ( α = .894) and its subscales physical health analysis can be used to deliver appropriate and timely inter - (α = .875) and relationships ( α = .837) was satisfactory. Ini - ventions, thus maximizing resource utilization while allowing tial construct validity was shown by observing moderate cor - relations ( r > 0.50, P < .01) between total QOL-MS and the for personalized care. Total health management is becoming MSQOL-54 overall QOL, role limitations, pain, health dis - an increasingly important component of disease manage - tress, and sexual function subscales and mental health com - ment. Additional claims-based research is in progress to facili - posite; between the QOL-MS physical function subscale and tate comprehensive clinical strategies that will significantly the overall QOL, physical health, role limitations, pain, health impact and improve the lives of Accordant patients with MS. distress, and sexual function MSQOL-54 subscales and men - Lakevia Hall, MS; Jason Cooper, MS; Andrew Krueger, MD tal health composite; and between the QOL-MS relationships Accordant—A CVS Caremark Company, Greensboro, NC, USA subscale and the overall QOL, role limitations, and cognitive Study supported by Accordant—A CVS Caremark Company. function MSQOL-54 subscales and mental health composite. Relapsing-remitting patients reported higher scores than pro - (S28) Withdrawn gressive patients for the total QOL-MS scale ( t = 3.89, P < .001) and QOL-MS physical function subscale ( t = 1.99, P = (S29) Tolerability and Adherence to Betaseron and .049), indicating discriminate validity. Discussion: Initial Copaxone in Phase 3 Clinical Trial reliability and validity of the 23-item QOL-MS scale is satis - Objective: Make direct comparisons of tolerability and factory. Further reliability and validity testing on a larger sam - adherence between interferon β-1b (IFN β-1b; Betaseron) and ple is warranted before using this self-assessment tool for MS glatiramer acetate (GA; Copaxone) in patients with relapsing- patients and their families to monitor their condition and eval - remitting multiple sclerosis (RRMS). Background: The uate outcomes of care. Betaseron/Betaferon Efficacy Yielding Outcomes of a New Elsie Gulick, PhD, FAAN, RN*; June Halper, MSCN, ANP, FAAN; Colleen Har - Dose study was a head-to-head trial comparing the safety, tol - ris, RN, NP, MSCN; Dianne Lowden, MSc(A), MSCN; Marie Namey, RN, MSN, β µ β µ MSCN; Amy Perrin-Ross, APRN, MSN, CNRN, MSCN6 ; Carol Saunders, BSN, erability, and efficacy of IFN -1b 500 g , IFN -1b 250 g, BA, MSCN and GA. Methods: Treatment-naive patients were random - *Rutgers, The State University of New Jersey, College of Nursing, Ringoes, ized to subcutaneous IFN β-1b 500 or 250 µg every other NJ, USA day or GA 20 mg daily for ≥104 weeks. Tolerability parame - ters were important secondary endpoints; adherence to treat - (S27) Top Reasons for Hospitalizations for People ment and incidence of adverse events were monitored With Multiple Sclerosis throughout the study. Results: The overall results of this study Objective: An exploration of top reasons for hospitaliza - (N = 2244) have been presented elsewhere; 897 patients tions was performed to reveal data-driven opportunities to were randomized to IFN β-1b 250 µg and 448 to GA 20 improve the health of people with multiple sclerosis (MS) mg. Adherence was higher with IFN β-1b 250 µg than with served by the AccordantCare program. Background: GA; slightly higher proportions of IFN β-1b 250- µg-treated

International Journal of MS Care 18 Posters patients completed treatment and completed the study. Influ - ment adherence and help with resetting expectations of ther - en zalike symptoms were initially more common in the IFN β- apy. Ongoing patient education and more individualized 1b 250- µg than the GA group but rapidly decreased with therapy are necessary to maintain adherence after years of time. Injection-site reactions (ISRs), particularly pain and pruri - treatment. tus, were more frequent with GA. Incidence of ISR diminished Patricia Kennedy, RN, CNP*; Jo Scanzillo, RN, MSCN; Kathleen with time in both groups. Other adverse events, including Costello, MS, CRNP fatigue, depression, arthralgia, and paresthesia, were similar *The Huega Center, Englewood, CO, USA in both groups. Alterations in liver enzymes, blood lipids, and Study supported by EMD Serono, Inc., and Pfizer Inc. thyroid function were slightly more frequent in the IFN β-1b 250- µg group, as were decreases in leukocytes. The inci - (S32) Natalizumab Safety and Utilization Update: dence of serious adverse events was slightly lower in the Results From TOUCH and TYGRIS IFN β-1b 250- µg group than the GA group. Further data will Background: Natalizumab (Tysabri) is the first α4-integrin be presented. Conclusions: This was the first large-scale receptor antagonist approved for the treatment of relapsing study to directly compare IFN β-1b with GA and confirmed multiple sclerosis (MS). Natalizumab is an important consider - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 the benign tolerability profile of IFN β-1b 250 µg. Adverse ation for patients with relapsing MS given its ability to reduce event frequencies were generally similar and as expected. relapse rates by up to 68% and the risk of disability progres - Adherence to IFN β-1b 250 µg was excellent and was slightly sion by 54% and its generally favorable tolerability profile. higher than to GA. After the occurrence of two cases of progressive multifocal Douglas Jeffery*; Barry G.W. Arnason; Giancarlo Comi leukoencephalopathy (PML) in natalizumab-treated patients *Wake Forest University, Department of Neurology, Winston-Salem, NC, USA and an extensive safety evaluation that revealed no addition - Study supported by Bayer Schering Pharma AG, Berlin, Germany. al cases, two risk-management programs to evaluate the long- term safety of natalizumab were initiated: the Tysabri Out - (S30) Withdrawn reach: Unified Commitment to Health (TOUCH) Prescribing Program and the Tysabri Global ObseRvation Program In (S31) Enhancing Treatment by Promoting Safety (TYGRIS). Methods: The TOUCH Prescribing Pro - Adherence in Multiple Sclerosis Patients gram ensures the appropriate and informed use of nataliz - Background: Multiple sclerosis (MS) patients on chronic umab; all US prescribers, infusion sites, and patients are therapy often experience a decline in adherence after 4–7 required to enroll in the program before initiating natalizum - years; however, this population is rarely targeted for continu - ab treatment. In TOUCH, the incidence of serious opportunis - ing education. Objectives: Develop techniques to identify tic infections, including PML, deaths, and discontinuations, patients on disease-modifying therapy (DMT) who may expe - are assessed. TYGRIS is a voluntary global observational rience a decline in DMT adherence, and emphasize the value study evaluating the long-term safety of natalizumab in the of individualized therapy for improving treatment adherence. clinical practice setting. Approximately 5000 patients, includ - Design/Methods: An MS LifeLines summit meeting was ing patients from TOUCH, will be assessed for medical/ held in 2007 to explore aspects of living with relapsing MS MS history; prior use of natalizumab or immunomodulatory, from the viewpoint of MS patient ambassadors and MS Life - antineoplastic, or immunosuppressive agents; and serious Lines nurses. Data from discussions and surveys of patients, adverse events, including serious opportunistic infections such nurses, and care providers were used to describe nonadher - as PML and malignancies, every 6 months for up to 5 years. ent patients who had been on DMT for ≥4 years and to Results: As of mid-December 2007, up to 30,900 patients derive strategies for improving treatment adherence. were treated with natalizumab in the clinical study and post - Results: Of MS patient ambassadors, 42% reported treat - marketing settings combined. The most current exposure and ment/needle fatigue after ≥2 years. From the patient perspec - safety data, including those from TOUCH and TYGRIS, will tive, barriers to treatment adherence included complacency, be presented. Conclusions: Preliminary results from TOUCH deterioration of injection technique, and adverse events. Iden - and TYGRIS support a favorable benefit-risk profile of natal - tifiers of nonadherence were increased complaints about izumab. Combined data from these studies represent the adverse events, patients providing vague responses to ques - largest long-term follow-up undertaken by any sponsor for a tions about therapy, and a surplus of unused syringes. Atten - single MS therapy and will increase our understanding of the dees of the meeting indicated that monitoring of adherence long-term safety of natalizumab in relapsing MS. should include patients being interviewed by the health care Choon Cha, MD; Richard Kim, MD; Glyn Belcher, MA, PhD; Carmen Bozic, team in detail at each visit to determine whether they are MD; Robert Hyde, PhD; Frances Lynn, MSc; Michael A. Panzara, MD, MPH; experiencing adherence-related issues. Strategies proposed Mariska Kooijmans-Coutinho, MD, PhD by attendees to individualize therapy and reestablish adher - Biogen Idec, Inc., Cambridge, MA, USA ence included discussing injection schedules to better fit the Study supported by Biogen Idec, Inc., and Elan Pharmaceuticals, Inc. patient’s lifestyle and assessing deficiencies in injection tech - (S33) Quality of Life as Impacted Through nique. MS ambassadors indicated that patients on chronic Therapeutic Recreation and Hydrotherapy treatment can benefit from periodic retraining in proper injec - tion technique, reinforcement of the expectations of therapy, This poster presents quality-of-life research gathered from both and increased support from peers and MS health care the participation in a multiple sclerosis (MS) hydrotherapy providers. Conclusion/Discussion: Frequent, thorough program and a specialized MS adult day program focusing patient interviews can identify patients struggling with treat - on therapeutic recreation. The use of annual client surveys

International Journal of MS Care 19 Posters that assess client perceptions of quality of life as a result of (S35) Physical and Patient-Reported Outcomes in attending a specialized adult day program and/or attending Multiple Sclerosis hydrotherapy provide the day program and hydrotherapy Objective: Most multiple sclerosis (MS) clinical trials focus program with a basis for understanding the perceptions of on relapses and magnetic resonance imaging measures of their quality of life and functioning. Clients have been given disease activity. Disease outcome measures in clinical trials these surveys anonymously for the past 10 years. Client and practice focus on physical outcomes, particularly the answers to each of the questions on physical and emotional ambulation-oriented Expanded Disability Status Scale (EDSS). functioning will be presented to show an overall picture of This study evaluated the relationship between various physi - client perceptions. We present results that clients state that cal and patient-reported outcomes (PROs) in MS patients. they have a high quality of life. Surface data show that the Methods: Charts were abstracted for 98 MS patients in a functioning of clients attending the day program has declined single MS center that captured both physician-evaluated out - over the 10 years; however, their perceptions of functioning comes and PROs. This study reports the last available evalua - and quality of life have not had the same decline. Based on tion. Spearman rank correlations and a recursive partitioning Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 these results, the day program and hydrotherapy program algorithm were used to evaluate relationships among five have and continue to try to improve their services to meet the physical (box/blocks, 9-hole peg, timed walk, Tinetti balance, and EDSS) and three PRO (Modified Fatigue Impact Scale, ever-changing needs of their clientele. Examples of outcome- Beck Depression Inventory, and Epworth Sleepiness Scale) based changes will be presented to show the benefit of client measures in addition to standard demographic and disease- surveys. characterizing variables. Results: The rank correlation Michelle King, MS, CTRS between the box/blocks and 9-hole peg tests (standard tests Rocky Mountain MS Center, Denver, CO, USA for fine motor control) was 0.90 ( P < .001), whereas the rank correlation between box/blocks and timed walk was 0.71 (S34) Long-Term Effect of Modafinil on Multiple (P < .001). Moderate correlations were observed for the Sclerosis–Related Fatigue PROs: fatigue and depression was 0.57 ( P < .001), fatigue Short-term studies have documented conflicting results regard - and sleepiness was 0.52 ( P < .001), and depression and ing the effect of modafinil on multiple sclerosis (MS)–related sleepiness was 0.39 ( P < .001). No significant correlations fatigue. In clinical practice, modafinil is commonly used to were observed between either depression or sleepiness and improve function in patients who have fatigue-related issues. any physical outcome measure. Fatigue was correlated with A previous retrospective analysis from our database of the the 9-hole peg test (0.41, P = .023), timed walk (0.44, P = effect of modafinil on MS-related fatigue in 64 patients .014), and EDSS (0.34, P = .013). The recursive partitioning showed a beneficial response in 80% at 12 months. A new algorithm found the strongest physical outcome associated retrospective analysis of patients treated at the Baptist Hospi - with fatigue to be EDSS, and the best split was at EDSS mini - tal East MS Center was performed. Inclusion criteria included mal vs mild disability. Conclusion: Moderate correlations were found within the physical outcome measures and within a diagnosis of definite MS by the and treatment PROs, but the relationship between physical outcomes and with modafinil for MS-related fatigue. A baseline Modified PROs was weak. Because most clinical trials and evaluating Fatigue Impact Scale (MFIS) score was obtained within 6 neurologists focus on physical measures in MS, much of the weeks of starting modafinil therapy. The changes in MFIS disease impact is probably being missed. scores were compared over time, and patients were followed Stephen Kirzinger, MD*; Michael B. Nichol, PhD; Jason P. Jones, PhD with the Beck Depression Inventory (BDI) and Expanded Dis - *University of Louisville, Louisville, KY, USA ability Status Scale (EDSS) over the same intervals. Inclusion Study supported by Bayer HealthCare. criteria were met by 112 patients. The repeated-measures technique with and without the covariates of EDSS and BDI (S36) Health Benefit Costs Among Employees With was used. The difference between the mean for intervals in Multiple Sclerosis which modafinil or an antidepressant were taken and inter - Background: Several disease-modifying therapies (DMTs) vals in which modafinil or an antidepressant were not taken are available for the treatment of multiple sclerosis (MS). Limit - in the same patient, who had intervals both with and without ed data are available on direct and indirect costs among treatment, were averaged over all such patients. Results show employed individuals with MS. Objective: Assess the differ - that 1) antidepressant treatment significantly affects BDI, ences in health benefit costs (HBCs) among employees treat - EDSS, total MFIS score, and the cognitive and physical sub - ed with DMTs for MS. Methods: A health care claims data - scale scores of the MFIS, and 2) modafinil does not signifi - base of US employees from 2001 to 2007 was used to cantly affect any of the response variables. A multivariate analyze HBCs. Records of 785 patients with MS (ICD-9 code analysis gives the same conclusions as the univariate analy - 340.XX) were extracted, assigned to cohorts based on DMT ses. Antidepressant treatment affects total MFIS scores, BDI, (interferon [IFN] β-1a intramuscularly [Avonex], IFN β-1b and EDSS (P = .044). Modafinil does not significantly affect a [Betaseron], glatiramer acetate [Copaxone], or IFN β-1a sub - linear combination of responses ( P = .3811). cutaneously [Rebif]), and followed for 1 year after their initial Stephen Kirzinger, MD; Justin Phillips, BA; Angela Siegwald, RN prescription. Two-part regression modeling was used to deter - University of Louisville—MS Care Center Program, Louisville, KY, USA mine the annual cost differences (in 2007 USD) between Study supported by the University of Louisville Summer Research Scholar cohorts while controlling for demographics, job-related infor - Program and CMSC Student Research Scholarship. mation, geography, and Charlson Comorbidity Index.

International Journal of MS Care 20 Posters

Results: Data from 311 employees ( n = 156 Avonex, 55 tion, hope, and appropriate safety planning can result in Betaseron, 87 Copaxone, and 13 Rebif) were eligible for maintaining, restoring, or increasing independence of people analysis. Aside from small geographic differences, all with MS who are in abusive relationships. Decreasing abuse patients were similar demographically. More Betaseron can ultimately impact physical, psychological, and emotional patients were full-time employees than Rebif patients (98.2 vs wellness. 84.6%), and Avonex patients had been with their current Sherie Lammers, Medical Advocate*; Anne Mageras, MSW; Margie O’Leary, employer longer than Copaxone patients (9.8 vs 7.0 years). MSN, RN, MSCN Total HBCs were lower for Avonex ($18,167) and Betaseron *Allegheny General Hospital, Pittsburgh, PA, USA ($17,953) than Rebif ($26,970) and Copaxone ($21,194). Study supported by FISA. Among the four DMTs, Avonex patients reported the lowest total sick leave and short-term disability costs. Of these, (S38) Resistance Exercise Training and Quality-of- Copaxone patients had significantly ( P < .05) higher sick Life Indicies in Multiple Sclerosis leave ($969 vs $523) and short-term disability ($1056 vs Multiple sclerosis (MS) symptoms often result in compromised

$87) costs than Avonex patients. Long-term disability costs physical and psychological health and consequently reduced Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 were numerically higher for Copaxone ($1046) than Avonex quality of life. Although regular physical activity increases ($202) patients ( P = .1925). Conclusions: Among employ - functional capacity in MS, its effects on quality-of-life indices ees treated for MS, Avonex patients reported the lowest sick are not well characterized. Objective: The purpose of this leave and short-term disability costs of the DMTs. These cost study was to investigate the effects of progressive resistance differences suggest that Avonex patients may have higher training on quality-of-life indices in MS. Methods: Nine vol - productivity and lower disability than employees treated with unteers (aged 50.4 ± 7.7 years, weight 84.2 ± 22.1 kg, dis - the other three DMTs for MS. ability score 5.1 ± 0.7/10) performed upper- and lower- Nathan Kleinman, PhD*; Krithika Rajagopalan, PhD; Richard A. Brook, MS, body exercises 3 days per week for 16 weeks. Participants MBA; Arthur K. Melkonian, MD completed the MS Quality-of-Life Inventory (MSQLI) before *HCMS Group, Cheyenne, WY, USA and after the training program. The MSQLI assesses 10 Study supported by Biogen Idec Pharmaceuticals, Cambridge, MA, USA. health-related domains specific to people with MS. Results: Improvements in upper- and lower-body muscle strength, mus - (S37) Independence Is Key Outcome of Effective cle endurance, and walking speed were observed after the Safety Planning in Abusive Relationships training program ( P < .05 for all). Of the 10 separate scales, scores improved for self-reported fatigue (MFIS; 17%), per - Introduction: Abuse is a common and underresearched ceived deficits questionnaire (33%), and health status ques - problem that is experienced by people with multiple sclerosis tionnaire (SF-36; 16%) (all P < 0.05), whereas the pain effect (MS) and other chronic disabling conditions. Abuse is the scale (27%) had a tendency to improve ( P = .10). Although unequal distribution of power and control in a relationship not significant, the average percentage change for the through mental, verbal, economic, sexual, and physical remaining seven scales were: mental health inventory 3%, abuse. The REACH Program of the National MS Society, modified social support scale 3%, sexual satisfaction scale Allegheny District Chapter, has developed a program to 6%, bowel control scale 12%, bladder control scale 19%, assist people with MS who have experienced abuse in any and impact of visual impairment scale 33%. Conclusion: relationship. Often, abuse victims report that they do not want Based on our results, progressive resistance training promotes to end their relationship; they just want to end the abuse. The favorable changes in quality-of-life indices and should be con - same holds true for abused people with MS but to a more sidered as an adjunctive therapy in MS. Further research with extensive degree. Most abuse victims are emotionally and a larger cohort of participants is needed to more fully charac - financially dependent on their violent partner. In addition to terize the influence of resistance exercise on health and quali - emotional and economic dependence, abuse victims with MS ty-of-life indices in people with MS. are often dependent on their partner for physical and cogni - Rebecca Larson, MS; Sean McCoy, MS; Lesley J. White, PhD tive aid. This dependence makes leaving abusive situations University of Georgia, Athens, GA, USA for people with MS even more difficult or impossible; subse - Study supported by the National MS Society. quently, increasing independence through effective safety planning becomes key to ending abuse. Methods: The (S39) Pure-Tone Hearing Sensitivity for Individuals chapter’s REACH Program assists every abused person in With Multiple Sclerosis devising an individualized service plan. Each plan includes a The nature and prevalence of auditory problems associated safety and emergency escape plan, referrals to local victims’ with multiple sclerosis (MS) is incompletely understood. No service agencies, crisis intervention, and empowerment coun - particular configuration of pure-tone hearing loss has been seling. Results: Over the past 2 years, 164 people with MS associated with MS, although some studies have suggested who reside within the chapter region have disclosed that they that a loss of hearing in the high frequencies and low fre - experienced abuse and have received services through this quencies may be common. Other studies suggest that only a program. In addition to safety planning, financial assistance small percentage of individuals with MS have any loss in was provided to compensate for losses as a result of the pure-tone hearing sensitivity. The purpose of the investigation abuse, including assistance for transportation (court, doctors’ was to examine further pure-tone hearing sensitivity in a large appointments), relocation (first month’s rent, security deposit, group of subjects with MS. Fifty subjects with a diagnosis of PO boxes), utilities (connection fees, unpaid balances), repa - definite MS completed a comprehensive audiometric evalua - ration (destroyed, damaged items), and respite (counseling, tion. Specifically, pure-tone air- and bone-conduction hearing attendant care). Conclusion: Empowerment through educa - thresholds were obtained at 250–8000 Hz in both ears via

International Journal of MS Care 21 Posters standard test procedures. To confirm pure-tone test results, (S41) Patient Decision Making About Treatment for measures of monaural speech recognition, which included the Multiple Sclerosis attainment of speech reception thresholds (SRTs) and word- recognition scores (WRSs), were also obtained. All testing People with chronic illnesses such as multiple sclerosis (MS) was conducted in a double-walled sound-treated chamber face daily self-care decisions and, in recent years, have that was adjoined to a single-walled control room and with sought greater involvement in their health care options. an audiometer and insert earphones. Study results revealed a Increasingly, nurses are playing key roles with their patients, mean pure-tone average of 21 dB in both ears. Similar results particularly in the decision-making process around MS thera - were obtained for the SRT in each ear. Mean WRSs of 93% py initiation. Although the treatment of MS has become possi - and 91% were obtained in the right and left ears, respective - ble with the advent of disease-modifying therapies, the ly. These average test results are consistent with normal hear - personal decision to initiate therapy is complex given the ing, which is not surprising given that most subjects had nor - absence of cure, the lack of clarity as to who will benefit and mal hearing in both ears (66%). In fact, only 12% of the to what degree, the lack of clear criteria for defining optimal subjects exhibited greater than a mild degree of hearing loss versus suboptimal response to therapy, and the possibility of in either ear. These results confirm that few individuals with continued disease activity despite treatment. The literature on Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 MS experience significant pure-tone hearing loss; however, the efficacy, risks, side effects, and adherence associated the percentage of individuals with MS having significant with the use of disease-modifying therapies in relapsing- hearing loss was slightly greater than that found in the remitting MS is proliferating. However, important gaps exist general population. The implications of these findings will about the patients’ treatment decision-making experience and be discussed. the different aspects involved in negotiating this decision to M. Samantha Lewis, PhD*; Michele Hutter, MS; David Lilly, PhD; Mary accept, refuse, or delay treatment (eg, health beliefs related Fitzpatrick, NP; Dennis Bourdette, MD; Stephen Fausti, PhD *National Center for Rehabilitative Auditory Research, Portland, OR, USA to using medication, developmental life priorities such as pregnancy, the role of the family, and the decision support (S40) Critical Analysis of Clinical Balance Tests in needs of individuals eligible for treatment). To effectively sup - People With Multiple Sclerosis port people faced with options about their health, evidence- based clinical strategies are needed that take into account Background/Purpose: Falls are common in patients with people’s values and life context. The purpose of this poster is multiple sclerosis (MS). Many clinical balance tests have been to present the preliminary findings from a phenomenological reported to be useful in assessing fall risk in elderly individu - study that explored the experience of making a first decision als. However, whether common clinical balance tests can be used to accurately predict fall risk in people with MS has not about treatment with disease-modifying therapies among indi - been confirmed. The purpose of this study was to determine viduals with different life histories of relapsing-remitting MS. whether the currently accepted cut-off scores established with - Key themes and the deliberative process that patients under - in the geriatric population for clinical balance tests are appli - go when they make a treatment decision will be highlighted. cable to patients with MS and to establish whether the sensi - The study findings will inform best practices and assist nurses tivity can be maximized. Participants: Participants were 35 in providing decision support and facilitating the decision- ambulatory people with a definitive diagnosis of MS aged making process for individuals with MS eligible for treatment. 41–72 years (mean [standard deviation] = 57.1 [8.70] Diane Lowden, MSc(A), MSCN*; Virginia Lee, PhD; Suzanne C. years; MS duration = 12.78 [10.26] years). Methods: Each Smeltzer, EdD, RN, FAAN individual completed the Berg Balance Scale (BBS), Dynamic *McGill University Health Centre, Montreal, QC, Canada Gait Index (DGI), Functional Reach Test (FRT), and 8’ Timed Study supported by Newton Foundation; the Foundations of the Montre - Up and Go (8’TUG). Based on a detailed fall history, partici - al General, Royal Victoria, and Montreal Children’s Hospitals; and the pants were divided into groups of fallers ( ≥2 falls in the past International Organization of Multiple Sclerosis Nurses. 6 months) and nonfallers (<2 falls in the past 6 months). Comparisons between faller and nonfaller groups were per - (S42) BG00012 () Activation of formed via independent t tests ( P < .05). In addition, validity Nrf2 and Modulation of Disease indices (sensitivity, specificity, receiver operating characteris - Background: Inflammatory and oxidative stress is thought tic curves, and likelihood ratios) were calculated for each bal - to contribute to central nervous system (CNS) damage in mul - ance test with currently accepted geriatric cut-off scores. tiple sclerosis (MS). We show that dimethyl fumarate (DMF), Results: Fifteen participants (43%) were classified as fallers. the active component of the novel oral MS therapeutic agent Scores between groups were statistically significant for the BG00012, is an activator of Nrf2, a transcription factor criti - BBS, DGI, 8’TUG, and stair climb test. The sensitivities cal for cellular resistance to oxidative stress and immune ranged from 0.47 to 0.80. The only test that showed a mod - homeostasis and recently implicated as a regulator of myelin erate sensitivity was the DGI (0.80). Specificity with the estab - maintenance and therapeutically relevant target for cyto- and lished cut-off scores ranged from 0.4 to 0.8. The BBS and 8’TUG tests had the highest specificities (80). Discus - neuroprotective agents. Methods: Effects of BG00012 on sion/Conclusion: Many complications are associated with Nrf2 stability and function were studied with Western blot - a fall, and relatively few adverse effects occur from fall pre - ting, immunohistochemistry, and reporter assays. Effects on vention. Therefore, we propose new cut-off scores that maxi - disease activity and CNS histological integrity were analyzed mize sensitivity for individuals with MS. in mouse and rat experimental autoimmune encephalomyelitis Cielita Lopez-Lennon, SPT; Carrie Hoffmeister, SPT; Warren Lake, SPT; (EAE) models. Results: DMF inhibited disease progression Lee Dibble, PT, PhD, ATC; Ed Gappmaier, PT, PhD and inflammatory infiltration of CNS in the acute mouse and University of Utah, Salt Lake City, UT, USA chronic relapsing rat EAE. In addition, DMF and its primary

International Journal of MS Care 22 Posters metabolite monomethyl fumarate (MMF) diminished demyeli - onset. Among men, the odds of a relapsing course were nation and axonal loss in late chronic mouse EAE. In vitro, increased if mental comorbidities (OR = 2.61, 1.18–5.88) DMF and MMF stabilized Nrf2, stimulated Nrf2-dependent were present. Conclusion: Comorbidities are often present transcriptional activity, and caused accumulation of NQO1, when MS is diagnosed and are associated with differences in the prototypical Nrf2 target gene product. Accordingly, the age at symptom onset, age at diagnosis, and type of clini - increased Nrf2 levels and NQO1 activity were detected in cal course. the CNS of DMF-treated animals. In the phase 2b study, Ruth Ann Marrie, MD, PhD*; Ralph Horwitz, MD; Gary Cutter, PhD; Tuula Tyry, BG00012 240 mg three times daily reduced the number of PhD; Denise Campagnolo, MD; Timothy Vollmer, MD new or enlarging T2 lesions over 6 months by 48% com - *University of Manitoba, Winnipeg, MB, Canada pared with placebo ( P < .001) but decreased the number of Study supported by National Institutes of Health, National Institute of new nonenhancing T1 black holes by 53% ( P = .014). Con - Child Health and Human Development, Multidisciplinary Clinical clusions: BG00012 is an activator of Nrf2, a transcriptional Research Career Development Program Grant K12 HD04909. regulator central to oxidative stress response, essential for

immune homeostasis, and identified as a major cyto- and (S44) Predictors of Perceived Stress in Multiple Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 neuroprotective mechanism. Taken together, the ability of Sclerosis Population BG00012 to activate Nrf2, its biological effects observed in Research has demonstrated associations between stressful life EAE, and the effect on nonenhancing T1 black holes in MS events and symptom exacerbation in people with multiple suggest that BG00012 may provide a distinct dual therapeu - sclerosis (MS). Stress may also affect individuals with a dis - tic modality by targeting an important neuroprotective and ability more severely because of their vulnerable health status anti-inflammatory pathway. and lack of adequate resources. The stress and coping litera - Matvey Lukashev, PhD*; Weike Zeng; Sarah Ryan; Kate Dawson, MD; Gilmore ture shows that patients’ perception of stressors is more pre - N. O’Neill, MB, MRCPI, MMedSc; Susan E. Goelz, PhD; De-Hyung Lee, MD; Ralf A. Linker, MD; Benjamin Drukarch, PhD; Ann-Marie Van Dam, PhD dictive of their level of distress and physical symptoms than is *Biogen Idec, Inc., Cambridge, MA, USA number of stressors. To fill gaps in the literature, we explored Study supported by Biogen Idec, Inc. which factors might contribute to the perception of stress in people with MS. A large cross-sectional sample ( n = 1063) of (S43) Comorbidity Influences Clinical community-dwelling adults with MS completed a self-report Characteristics of Multiple Sclerosis mail survey. Information on demographics, health symptoms, social support, and MS disability were collected. Perceived Background: Comorbidity may affect the clinical pheno - stress was assessed with the 4-item Perceived Stress Scale type of chronic diseases including multiple sclerosis (MS). (PSS). Multiple linear regression modeling was used to identi - Phenotypic differences may be important for prognosticating fy factors significantly associated with perceived stress. In our and making treatment decisions. Little is known about the influence of comorbidity on clinical characteristics of MS. sample, the mean PSS score was 6.20 (standard deviation = ≥ Objective: Using the North American Research Committee 3.60), with 28.4% of patients scoring 9 (scale 0–16). on Multiple Sclerosis (NARCOMS) registry, we described Increased depression, fatigue, and level of disability were comorbidities present at diagnosis of MS and determined associated with increased stress, whereas increased social whether comorbidities present at diagnosis influence age at support and age were associated with reduced stress. Of symptom onset and diagnosis or clinical course. Methods: the variance in stress explained by the model, depression Registry participants self-report demographic and clinical explained significantly more variance than any other factor. information regarding their MS at enrollment and semiannual - These results suggest that 1) certain person- and disease- ly thereafter. In fall 2006, participants were queried regard - related variables play an important role in the perception of ing physical and mental comorbidities, including date of stress among people living with MS, and 2) perceived stress diagnosis, smoking status, current height, and past and cur - in people with MS may be higher than that reported by other rent weight. We grouped comorbidities into categories (physi - chronically ill populations (eg, patients with kidney disease). cal, mental, vascular, autoimmune, cancer, visual, musculo - Although the relationship between depression and perceived skeletal, and gastrointestinal) and categorized participants stress should be interpreted with caution, our findings could according to the presence or absence of comorbidity at onset be used to guide development of stress management interven - and diagnosis of MS. We compared the clinical course at tions for patients with MS. onset between affected and unaffected participants in each Angeli Mayadev, MD; Brenda Stoelb, PHD; Alyssa Bamer, MPH; Dawn comorbidity category and compared ages at symptom onset Ehde, PHD and diagnosis. Results: At MS diagnosis, a substantial pro - University of Washington Western MS Center, Seattle, WA, USA portion of affected people had physical (24%) or mental Study supported by grants from the US National Institute on Disability (18%) comorbidities, a positive smoking history (53%), and and Rehabilitation Research (#H133B031129) and the National Insti - overweight or obesity (50%). Vascular, autoimmune, cancer, tutes of Health (#5U01AR052171-03) to University of Washington. visual, and musculoskeletal comorbidities were associated (S45) Age and Comorbidity in Veterans With with a later age at symptom onset and diagnosis. Among Multiple Sclerosis women, the odds of a relapsing course at onset were increased if obesity (odds ratio [OR] = 1.55, 1.21–1.98), Background : Few studies have systematically examined mental (OR = 1.47, 1.13–1.92), or gastrointestinal (OR = comorbid conditions in patients with multiple sclerosis MS. 1.63, 1.12–2.36) comorbidities were present at symptom Concurrent with MS-associated conditions, increasing age

International Journal of MS Care 23 Posters also confers vulnerability for many health conditions. Under - relapse were used to evaluate relapse prevalence during the standing patterns of comorbidity in MS patients across age 24-month follow-up period: 1) MS hospitalization or ER visit, spans could potentially enhance delivery and focus of health 2) definition 1 plus injectable methylprednisolone use, 3) defi - care services. Objective : Explore the prevalence of co - nition 1 plus any steroid use, or 4) definition 3 plus presence mor bidity conditions in veterans with multiple sclerosis (MS), of a diagnosis indicating worsening symptoms. Results: and examine the relationship of comorbidity and age. Subjects ( N = 2400) had a mean (standard deviation) age of Design/Methods : We identified 16,074 MS veterans from 43.9 (9.4) years, and 76.3% were women. Relapse was fiscal years 1998–2006 through a retrospective query of the identified in 8.2% ( n = 197) of patients by using the most Veterans Health Administration database. MS patients were restrictive definition of ≥1 MS hospitalization or ER visit. The classified into six age groups (<35, 35–44, 45–54, 55–64, percentage of patients meeting the definition of a relapse ≥ 65–74, and 75 years). We calculated prevalence of each increased to 19.9% ( n = 454) when use of injectable methyl - selected condition from both inpatient and outpatient encoun - prednisolone was included in the definition and further χ2 ters. test was applied to examine the relationship between increased to 44.3% ( n = 1064) with the use of any steroid. prevalence and age. Results : Across all ages, psychiatric Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Application of the most liberal definition resulted in 79% ( n = disorders, hypertension, depression, neurogenic bladder, and 1897) of patients identified with a relapse. Conclusion/ spinal cord injury were the top five leading comorbid condi - Discussion: The prevalence estimates of relapse vary tions (27–44% of patients). Many MS- and age-associated depending on the claims-based criteria applied and highlight conditions were found in which prevalence increased signifi - the need for validation of claims-based criteria with clinical cantly with age ( P < .0001). These included but were not lim - records to accurately identify MS relapses. ited to urinary tract infection, neurogenic bladder, decubitus ulcer, arthritis, hypertension, and ischemic heart disease. Dennis Meletiche, PharmD*; Chris Kozma, PhD Alcoholism and substance abuse significantly decreased with EMD Serono, Inc., Rockland, MA, USA age ( P < .0001). Psychiatric disorders and depression were Study supported by EMD Serono, Inc., and Pfizer Inc. most prevalent in the middle three age groups (range 38– 49%) and least prevalent in the two oldest age groups. Rela - (S47) Treatment Adherence and Severe Relapses in tionship of comorbidity to MS subtype and disability are Multiple Sclerosis Patients being explored among a subset of the patients who partici - Background: Disease-modifying drugs (DMDs) can reduce pated in our Multiple Sclerosis Surveillance Registry. Conclu - the frequency and severity of multiple sclerosis (MS) relapses. sion/Discussion : Elderly MS patients suffered most with MS requires long-term treatment, and little is known about the various MS- and age-associated conditions that require com - relationship between treatment adherence and incidence of prehensive service strategies to optimize their health status. MS relapses. Objective: Evaluate the relationship between Clinicians should be aware of the many forms of psychiatric treatment adherence and the incidence of severe relapses via disorders in young and middle-aged patients and provide the medication-possession ratio (MPR). Design/Methods: early interventions and treatment. MS patients, selected from the PharMetrics (Watertown, MA, Tzu-Yun McDowell, MA*; William J. Culpepper, MA; Douglas D. USA) Patient-Centric database, had ≥1 MS diagnosis or ≥1 Bradham, PhD, MA, MPH DMD prescription claim (interferon β-1a, interferon β-1b, or MS Center of Excellence–East and University of Maryland, Baltimore, MD, USA glatiramer acetate) between 1 July 2000 and 31 December Study supported by the MS Center of Excellence–East, Baltimore, MD, 2004. Continuously eligible patients were evaluated for USA. 6 months before the date of first DMD prescription (index ≥ (S46) Multiple Sclerosis Relapse Prevalence: Effect date) and 24 months after the index date. Evidence of 1 of Varying Definitions From Claims Database MS-related hospitalization or emergency room visit was used to define a severe relapse. Adherence was measured by Background: Administrative claims information would be MPR, and patients were categorized as adherent ( ≥80%) or useful for conducting outcome studies of the effectiveness of nonadherent (<80%). Covariates included age, drug, sex, multiple sclerosis (MS) therapies; however, consensus criteria and treatment history (naive vs previously treated). Previously to identify patients who experience a relapse are lacking. treated patients had ≥1 DMD prescription in the 6 months Objective: Explore alternative definitions of relapse using before the index date. Results: Subjects ( N = 2400) had an claims-based data to document estimates of relapse preva - average (standard deviation) age of 43.9 (9.4) years, 76.3% lence in MS patients. Design/Methods: Subjects were were women, and 77.8% ( n = 1867) were enrolled in com - identified from the PharMetrics (Watertown, MA, USA) mercial plans (HMO 38.6% [ n = 927], PPO 40.8% [ n = Patient-Centric database who were diagnosed with MS or 978]). During the evaluation period, 8.2% ( n = 197) of had ≥1 disease-modifying drug (DMD) prescription claim patients had evidence of a severe relapse. The age and sex (interferon β-1a, interferon β-1b, or glatiramer acetate) from 1 of patients with severe relapse closely reflected that of the July 2000 through 31 December 2004. In continuously eligi - entire sample. Of patients with severe relapses, more were ble patients, relapse occurrence was evaluated for the 24 nonadherent than adherent (61.4% [ n = 121] vs 38.6% [ n = months after the first DMD prescription claim. Variables used 76], respectively). With severe relapses as the dependent to identify relapses included hospitalization, emergency room variable, a logistic regression for MPR, age, sex, drug, and (ER) use, steroid use, and worsening of symptoms (eg, ataxia, patient type found nonadherent patients twice as likely to spasticity, tremor, speech problems). Four definitions of have experienced a severe relapse (odds ratio = 1.976; 95%

International Journal of MS Care 24 Posters confidence interval, 1.462–2.686) compared with adherent (S49) Relationship Between Pain and Clinical patients. Conclusion/Discussion: In this study, nonadher - Outcomes in Multiple Sclerosis: ence with DMD therapy was significantly associated with Effects of Natalizumab higher likelihood of severe relapses. Background: Patients with multiple sclerosis (MS) often Dennis Meletiche, PharmD*; Chris Kozma, PhD; Randy Bennett; Ahmad experience pain, which compromises routine functioning and AL-Sabbagh, MD health-related quality of life (HRQOL). Natalizumab (Tysabri) EMD Serono, Inc., Rockland, MA, USA demonstrated significant efficacy on clinical outcomes and Study supported by EMD Serono, Inc., and Pfizer Inc. HRQOL in pivotal studies of relapsing MS patients. The rela - tionship between disease activity and pain in relapsing MS (S48) Efficacy and Safety Outcomes in Multiple and the effects of natalizumab were evaluated. Methods: Sclerosis Patients Treated With Data from AFFIRM (natalizumab monotherapy) and SEN - β Objective: Determine short-term clinical effectiveness and TINEL (natalizumab + interferon -1a) patients were ana - lyzed. Changes in Medical Outcomes Study Pain Effects

long-term safety of mitoxantrone therapy for multiple sclerosis Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Scale (MOS-PES) scores (baseline range 6–30) from baseline (MS), and identify factors that best predict outcomes and to year 2 were determined. An ordinary least-squares regres - rates of or reasons for treatment discontinuation. Back - sion model was used to assess associations between baseline ground: Most mitoxantrone studies describe MS patients patient demographics or disease characteristics and pain. treated in Europe or clinical trials. Use of immunosuppres - Furthermore, relationships between on-study relapse rates or sive/disease-modifying therapies and methods of health care disability progression and changes in MOS-PES score were delivery vary by country. This may affect rates of treatment evaluated. Natalizumab treatment effects were assessed with continuation, efficacy, adverse events, and posttreatment an analysis of covariance adjusted for baseline Expanded monitoring of compliance. Design/Methods: A total of Disability Status Scale (EDSS) and MOS-PES scores. Results: 129 patients aged 18–67 years were studied (28 relapsing, AFFIRM patients with baseline EDSS scores ≥2.0 had higher 101 secondary progressive [SP]). A priori treatment plans baseline MOS-PES scores than patients with baseline EDSS were established for each patient with a goal of stabilization: scores of 0 (11.9–16.7 vs 9.3; P ≤ .017). Similar results cumulative dose median 33.2 mg/m 2 (range 2.2–80.8 were observed in SENTINEL. MOS-PES scores improved from mg/m 2). Ninety patients received treatment at a hospital- baseline to year 2 in placebo patients without relapses and based MS clinic between 1 December 2000 and 4 July worsened in those with ≥2 relapses (AFFIRM: –0.65 vs 1.84; 2004 (group 1); 39 were in one private practice from 1 Janu - SENTINEL: –0.44 vs 1.29; P = .010). Similarly, MOS-PES ary 2004 to 9 January 2007 (group 2). Results: Early treat - scores improved from baseline to year 2 in placebo patients ment discontinuation occurred in 55 of 90 group 1 patients without EDSS progression and worsened in those with pro - (61.1%). Reasons for discontinuation were ineffectiveness, gression (AFFIRM: –0.26 vs 2.13; SENTINEL: –0.10 vs 1.28; doctor’s decision ( n = 13), patient’s decision ( n = 20), and P ≤ .013). Natalizumab improved changes in MOS-PES serious adverse events ( n = 22). Likelihood of discontinuation scores over 2 years compared with placebo ( n = 175; –1.69 increased with increasing age regardless of Expanded Dis - vs 0.59; P = .023) in an analysis that excluded patients in the ≤ ability Status Scale (EDSS) score, MS type, or dose ( P < most benign disease quartiles (baseline MOS-PES score 8 or ≤ .007). One death from heart failure and one non-Hodgkin’s EDSS score 1.5). Conclusions: Pain is related to relapses lymphoma occurred (group 1) during posttreatment follow-up, and EDSS progression in MS. Natalizumab treatment was associated with more pain improvement in patients with high - and no therapy-related leukemias occurred. Group 1 patients er baseline levels of disability and pain. were followed 2–4 years posttreatment; group 2 follow-up is ongoing. Patients became less compliant with posttreatment Deborah Miller, PhD, LISW*; Richard A. Rudick, MD; Peter A. Calabresi, MD; Christian Confavreux, MD; Steven Galetta, MD; Gavin Giovannoni, MBBCh, monitoring recommendations over time. Clinically relevant PhD; Eva Havrdova, MD; Michael Hutchinson, MD; Ludwig Kappos, MD; reductions in annualized relapse rate were observed (mean Fred D. Lublin; David H. Miller, MD; Paul W. O’Connor, MD; J. Theodore baseline 0.91, at 12 months 0.38; P < .001). Patients with Phillips, MD, PhD; Chris H. Polman, MD, PhD; Ernst-Wilhelm Radue, MD; William Stuart, MD; Andrzej Wajgt, MD; Bianca Weinstock-Guttman, MD; one or more prestudy relapses per year experienced a Daniel Wynn, MD; Amy Pace, ScD; Robert Hyde, PhD; Richard Kim, MD; 74.0% reduction from baseline relapse rate. Thirty-four group Michael Panzara, MD, MPH 1 SP patients had worsened by ≥1.0 EDSS point during the *Mellen Center for Treatment and Research in Multiple Sclerosis, Cleveland year before starting mitoxantrone; 88.2% ( n = 30) had stabi - Clinic Foundation, Cleveland, OH, USA lized or improved by ≥1 EDSS point after 1 year’s treatment. Study supported by Biogen Idec and Elan Pharmaceuticals. Conclusions/Relevance: Mitoxantrone safety and effica - (S50) Impact of Magnetic Resonance Imaging cy results were consistent with known profiles, with significant Testing on Multiple Sclerosis Patients’ Treatment clinical benefit observed during year 1. Increased emphasis Decisions, Adherence to Medication, and on posttreatment monitoring among MS patients receiving Management of Overall Health Care mitoxantrone in outpatient care settings is recommended. Colleen Miller, BS, MS, DNS*; Diane Cookfair, PhD; David Hojnacki, MD; Magnetic resonance imaging (MRI) is an important tool in Robert Zivadinov, MD, PhD; Peter Kinkel, MD; Jyotsna Rajeswary, MD; diagnosing multiple sclerosis (MS) and tracking its progres - Frederick Munschauer, MD; Joan Feichter, RN; Bianca Weinstock-Guttman, MD sion. Although MRI exams enable physicians to better under - *The William C. Baird MS Center, Buffalo, NY, USA stand and manage the treatment of their MS patients, unin - Study supported by EMD Serono, Inc. sured and underinsured MS patients are often unable to

International Journal of MS Care 25 Posters afford an MRI. Through the MRI Institute, the Multiple Sclero - ty of life, along with a visual analog scale to measure poten - sis Association of America (MSAA) provides financial assis - tial symptoms from the chemotherapy. Measures were taken tance to MS patients in obtaining an MRI. MSAA recently every 3 months for 20 patients with RRMS and secondary conducted a survey of patients who have participated in the progressive MS as they received mitoxantrone for up to 2 MRI Institute to find out how the MRI results had affected their years. Results regarding symptoms of MS showed 70% reduc - treatment plan and the overall management of their MS. A tion in some pain, some trouble walking, and some trouble survey was sent out to MS patients who had used the MRI getting around. Results regarding quality of life found 55% Institute within the past year; 220 patients completed and reduction in some worry over getting worse, 45% reduction returned the survey. Whereas 51% of patients reported that in some feeling trapped, 40% reduction in some feeling use - their doctor suggested having an MRI at least once a year, less. Some side effects were also reduced 55% (eg, for nau - 93% of respondents needed the MRI Institute to either cover the full cost of an MRI (63%) or pay their insurance deductible sea, 40% down to 5% with none at all) after mitoxantrone. (30%). Ninety-one percent of patients discussed the results of Linda Moore, EdD, MSN, APRN University of North Carolina Charlotte, School of Nursing and Carolinas Health their MRI with their physician, and 29% reported that the MRI Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 had shown that their condition had worsened. Seventy-five Care, MS Center, Charlotte, NC, USA percent of respondents currently use a US Food and Drug Study supported by EMD Serono, Inc. Administration–approved medication to treat their MS. After receiving the results of their MRI, 29% of respondents report - (S52) Physical Activity and Quality of Life in ed that they had resumed taking their prescribed medication Multiple Sclerosis: Roles of Disability, Fatigue, after having stopped for some time, switched from one Mood, Pain, Self-Efficacy, and Social Support approved MS medication to another, or used one of the MS medications for the first time. Participants were also asked Background: There has been a growing interest by about other lifestyle changes they made after receiving their researchers and clinicians in physical activity’s influence on MRI results: 78% reported making one or more positive quality of life (QOL) in multiple sclerosis (MS). Based on a lifestyle changes, 48% reported making two or more positive recent meta-analysis, physical activity training has resulted in changes, and 27% reported making three or more positive a small improvement in QOL among people with MS (g = changes. Specifically, 39% reported making changes in their 0.23; 95% confidence interval, 0.15–0.31). The effect of lifestyle (ie, diet, exercise, rest), 32% began receiving treat - physical activity on QOL may not be direct but rather indirect ment for an MS symptom, 33% visited or scheduled a visit to and operate through factors such as disability, fatigue, mood, an MS clinic or specialist, and 35% became more active in pain, self-efficacy, and social support. Purpose: This study monitoring their MS and/or seeking out more information examined variables that might account for the relationship about MS. The research suggests that MRI results have a posi - between physical activity and QOL in people with MS. tive effect on decisions made by MS patients in regard to Methods: The sample ( N = 292) included individuals with their treatment options, adherence to a prescribed medica - a definite diagnosis of MS. The participants wore an tion, and managing their overall health care. accelerometer for 7 days and then completed a self-report Amanda Montague, EdM*; Robert Rapp, MAPA; Manuela Bechtel; Ronald measure of physical activity and measures of disability, Ringer; Jack Burks, MD *Multiple Sclerosis Association of America, San Francisco, CA, USA fatigue, mood, pain, self-efficacy, social support, and QOL. Study supported by the Multiple Sclerosis Association of America. The data were analyzed with covariance modeling in Mplus 3.0. Results: The model provided an excellent fit for the (S51) Functional Assessment and Clinical Before data ( χ2 = 51.33, df = 18, P < .001, standardized root- and After Mitoxantrone mean-square residual = 0.03, comparative-fit index = 0.98). Those who were more physically active reported lower levels Mitoxantrone (Novantrone) is US Food and Drug Administra - of disability ( γ = − .50), higher levels of social support ( γ = tion approved for administration for aggressive forms of multi - .20), self-efficacy for managing MS ( γ = .41), and self-effica - ple sclerosis (MS), including relapsing-remitting and second - cy for regular physical activity ( γ = .49). In turn, those who ary progressive MS (RRMS), recognizing the potential risk of reported lower levels of depression ( β = − .37), anxiety ( β = cardiomyopathy and leukemia. In considering this therapy, −.15), fatigue ( β = − .16), and pain ( β = − .08) and higher the side effects alopecia, nausea, vomiting, urinary tract levels of social support ( β = .26) and self-efficacy for control - infections, and oral lesions must also be weighed by the ling MS ( β = .17) reported higher levels of QOL. Conclu - health care provider (HCP), MS patient, and family. The deci - sion: The observed pattern of relationships supports the pos - sion to begin, continue, or stop treatment with this chemother - sibility that physical activity is indirectly associated with apy is determined by the HCP and patient based on out - improved QOL in individuals with MS via depression, comes and expectations from the treatment. Clinically, both fatigue, pain, social support, and self-efficacy for managing neurological assessment and magnetic resonance imaging MS. have shown that the drug has been physiologically beneficial, Robert Motl, PhD; Edward McAuley, PhD; Erin M. Snook, MS; Rachael C. but no data have been reported before this study describing Gliottoni, BS patients’ quality-of-life indicators and functional abilities. This University of Illinois at Urbana-Champaign, Urbana, IL, USA study used the validated Functional Assessment of Multiple Study supported by the National Institute of Neurological Diseases and Sclerosis (FAMS) to measure symptom experiences and quali - Stroke (NS054050).

International Journal of MS Care 26 Posters

(S53) Meningococcal and Human Papilloma Virus remained on the same MS treatment for ≥1.5 years. The spe - Vaccine Associated With Recurrent Acute cific drug used, younger age, and being naive to MS treat - Disseminated Encephalomyelitis ment before the index drug were all predictive of stopping or switching therapies. Acute disseminated encephalomyelitis (ADEM) is a clinical diagnosis of an inflammatory . The clin - Study supported by Biogen Idec. ical course is usually monophasic, but relapses can occur. Beth L. Nordstrom, PhD, MPH*; Christopher Seaman; Matthew W. Reynolds, PhD; Kitty Rajagopalan, PhD Multiple sclerosis (MS) is the most common idiopathic de - *United BioSource Corporation, Medford, MA, USA myelinating disease seen in clinical practice that can be diffi - cult to differentiate from recurrent ADEM. This disease state (S55) Treatment Gaps and Incidence of Severe has been described after viral infections and various vaccina - Multiple Sclerosis Relapses tions. No cases have been reported to date that are associat - ed with the HPV vaccination. Also, no clinical-based evidence Background: Patients often decline therapy for various rea - guidelines or biological markers exist for the diagnosis. We sons, which may be associated with a return of their multiple describe a case of recurrent ADEM after human papilloma sclerosis (MS) symptoms. Objective: Evaluate the relation - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 virus (HPV) vaccination. An 18-year-old woman developed ship between medication gaps and severe MS relapses. fever and right side hemiparesis 1 week after HPV vaccina - Design/Methods: Patients studied had made ≥1 disease- tion. Computed tomography, magnetic resonance imaging, modifying drug (DMD; Avonex, Betaseron, Copaxone, Rebif) and cerebrospinal fluid were obtained. The patient was diag - claim from 1 January 2000 through 31 December 2004 and nosed with ADEM and received intravenous Solumedrol for 3 were continuously eligible for 24 months after their first DMD days, after which her symptoms significantly improved. Six prescription (index data) and 6 months before the index data weeks later, the patient developed left-sided hemiparesis and were selected from the PharMetrics (Watertown, MA, USA) cranial nerve dysfunction. Again, treatment was initiated with database. Exclusion criteria included age <18 or >65 years, intravenous Solumedrol, and symptoms improved. Conclu - use of Tysabri after the index date, study drug use in a health sions: Discrimination between ADEM and MS can be diffi - care facility, or residence in a long-term care facility. An MS- cult; the diagnosis remains clinical and radiological. HPV vac - related hospitalization or emergency room visit was used to cination needs to be considered as the etiology of ADEM. define a severe MS relapse. The maximum gap in therapy Juan Carlos Muniz, MD; Stanley Krolczyk, DO, RPH; Lise Casady, ARNP (Maxgap), defined as the longest continuous period with no University of South Florida, Tampa, FL, USA evidence of study drug availability based on dispensing data and days’ supply, was categorized as 0–10, 11–89, and (S54) Persistence With Interferon β and Glatiramer 90+ days. Covariates included age, sex, geographic region, Acetate for Multiple Sclerosis treatment status, comorbidities, and therapy type. Results: A total of 2388 patients met the study criteria. The mean age of Background: Disease-modifying treatments for multiple scle - patients was 43.9 years, 76.4% were women, and 76.7% rosis (MS) have demonstrated efficacy in improving clinical were new patients. Over the 24-month study period, 8.1% disease course. The current study examined patterns and pre - had one or more severe MS relapses. The 90+-day Maxgap dictors of persistence with multiple sclerosis (MS) treatments, group was significantly associated with an increased risk of including interferon β and glatiramer acetate (GA). Meth - severe relapse versus the 0- to 10-day group (odds ratio ods: From the PharMetrics medical claims database, adults [OR] = 1.925; P = .007). A reduced risk of severe relapse diagnosed with MS who initiated treatment with interferon β (Avonex, Betaseron, or Rebif) or GA between 1995 and was associated with monotherapy with any of the DMDs 2005 were identified. We estimated continuous duration on (OR = 0.450–0.552). Other significant covariates were the index treatment and time to treatment switch or discontinu - comorbidity and East region (OR = 1.090 and 1.495, ation during 18 months of follow-up. Comparisons among respectively). Age, sex, and the other regions were not signifi - α MS drugs were performed with Cox proportional hazards cant at = .05. Conclusion/Discussion: A higher risk of models, adjusting for other identified predictors of persist - severe MS relapse was associated with gaps in DMD therapy ence. Results: A total of 6134 patients initiated treatment that exceeded 90 days compared with shorter or no gaps. with a study drug (2146 Avonex, 590 Betaseron, 1174 Darin T. Okuda, MD, MSc*; Chris Kozma, PhD; Michael Dickson, PhD; Rebif, and 2224 GA); their mean age was 43 years, 78% Dennis Meletiche, PharmD were women, and 16% had treatment with another MS drug *University of California, San Francisco, UCSF Multiple Sclerosis Center, San Francisco, CA, USA before start of the index drug. At 1 year after index-drug Study supported by EMD Serono, Inc., and Pfizer Inc. start, 3988 (65%) patients persisted with the index drug, 1594 (26%) discontinued MS treatment for at least 90 days, (S56) Improved Quality of Life Among Patients and 552 (9%) switched to a different MS drug. Compared Treated Long Term With Glatiramer Acetate with Avonex initiators, patients initiating Betaseron were 2.4 times as likely to discontinue or switch during 18 months of Objective: Compare health-related quality of life (HRQOL) follow-up (95% confidence interval [CI], 2.1–2.8). Persistence among relapsing-remitting multiple sclerosis (RRMS) patients with Avonex was nonsignificantly higher than with Rebif and receiving long-term glatiramer acetate (GA) treatment with GA. Discontinuing and switching treatment were more likely those having similar disease duration but remaining untreated among those aged <35 years (hazard ratio = 1.2; 95% CI, or treated short term with GA or β-interferons. Methods: 1.1–1.4) and with no prior use of another MS drug (hazard Patients followed in year 9 of the prospective, open-label con - ratio = 0.8; 95% CI, 0.7–0.9). Conclusions: Most patients tinuation of the US pivotal study of GA were consented for

International Journal of MS Care 27 Posters this cross-sectional survey (GA group) at office visits. MS sur - Secondary endpoints include self-efficacy, cognitive status, veys were presented for home completion and mailing back. depression status, quality of life, Expanded Disability Status Concurrent RRMS comparators from the Consortium of MS Scale progression, and relapse rate. Results: This study is in Centers NARCOMS registry were selected by matching 4:1 progress. Twenty-one subjects are currently enrolled. Prelimi - (untreated) and 1:1 (per treatment) on sex, education level, nary interim results suggest that the module-based intervention current age + 2 years, and duration of MS. Returned post - method produces superior treatment adherence and self- cards affirming participation prompted mailed MS surveys. efficacy compared with the individualized approach or place - Each survey included the validated MS Quality of Life Invento - bo. Implications: Results of this study are expected to pro - ry (MSQLI) and Goodin’s MS Questionnaire (disability); satis - vide direction to health professionals specializing in the care faction with life, health, therapy (lower scores = more satisfac - of MS patients by contributing to the evidence base for the tion); and sociodemographic characteristics. Matched paired selection and delivery of psychoeducational interventions in comparisons used Hotelling multivariate T-square analysis and RRMS. McNemar’s test. Results: Response rates were 94.8% for Brant Oliver, NP, MSN, MPH, MSCN; Kathleen A. Ryan, RN, MSCN; Lucille Boyle, LPN, MSCS; Heather Wishart, PhD; Laura Flashman, PhD; Jane the GA group and 78.4% for comparators. The GA group Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 reported significantly more life satisfaction (mean 2.20 vs Stephenson, MSW, LSW; Cynthia Stewart, MS; Nancy Yazinski, NP, MSN; Stacey Bowen, RN; Lloyd H. Kasper, MD 3.03; 95% confidence interval [CI], 0.03–1.45) and better DHMC—MS Center, Lebanon, NH, USA health on the Mental Component Summary score (mean Study supported by Teva Neuroscience. 49.55 vs 44.59; 95% CI, –10.43 to –0.09) of the SF-36 in the MSQLI than matched untreated comparators. Relative to (S58) Quality of Life in Long-Term Care of matched comparators treated with short-term GA or β-interfer - Multiple Sclerosis ons, the GA group had significantly lower mean disability scores and better health on the Physical Component Summary Quality of life in multiple sclerosis (MS) cannot be discussed score of the SF-36 and greater satisfaction with therapy. without considering the long-term-care aspect of the disease. Conclusions: This comparative study of HRQOL suggests Long-term care affects the client, the caregiver, and the profes - that patients with RRMS who have been treated with GA sionals who care for them. The quality is dependent on the long term have realized more life satisfaction and better resources of the given area in which they live, the support sys - mental health than those with a similar disease duration tems, and the knowledge of the professional to guide them in who remain untreated, and their physical function may be the process. The research on long-term care in MS is limited. better than those who have been treated short term with GA The purpose of this study was for professionals to discuss the or β-interferons. complex challenges of providing long-term-care management MerriKay Oleen-Burkey, PhD*; Kenneth Johnson, MD; Olympia Hadjimichael, to people with MS and their families in both rural and metro MPH; Timothy Vollmer, MD settings. Our method of collecting data was to develop a Teva Neuroscience, Kansas City, MO, USA long-term-care management task-force contract with an inde - Study supported by Teva Neuroscience. pendent party to hold roundtables in multiple areas of the Lone Star Chapter (TX, USA) of the National MS Society. The (S57) Targeted Psychoeducational Intervention in meeting included a presentation informing the audience of Multiple Sclerosis the resources of the chapter. A written survey was completed by the participants, and discussion ensued. A series of ques - Purpose: Use targeted psychoeducational interventions to tions were asked of the participants: 1) define long-term-care improve immunotherapy treatment adherence, self-efficacy, management, 2) list five challenges that exist in providing and quality of life in patients with relapsing-remitting multiple long-term care, 3) discuss gaps in services and resources, sclerosis (RRMS). This study was presented as a concept and 4) state what the Lone Star Chapter can do to support poster at the 2007 CMSC conference. Interim results for the professionals in providing services to clients and their care - first year of the study are presented here. Background/ givers. A total of 64 people completed the survey. Our data Significance: Psychoeducational interventions such as document the top four definitions of long-term-care manage - immunotherapy injection training, counseling regarding real - ment of MS, the top five challenges, the top five gaps in serv - istic treatment expectations, and health education on key ices, and what the Lone Star Chapter can do to support pro - symptomatic management and lifestyle issues have all been fessionals dealing with these issues daily. successful in improving immunotherapy treatment adherence, Barbara Olsen, MSN, NO; Sandra Ganske-Howell, RNC self-efficacy, and quality of life. However, no systematic National MS Society Lone Star Chapter, Houston, TX, USA research has been conducted on the optimal delivery format Study supported by the National MS Society Lone Star Chapter. for psychoeducational intervention in RRMS. This protocol studies two intervention strategies: a module-based education (S59) Relationship Between Magnetic Resonance approach and an individually tailored education model. Imaging T2 Lesion Localization and Sleep Method: This is a prospective, randomized, 1-year, 3-arm, Disorders in Multiple Sclerosis placebo-controlled pilot study. People with RRMS aged 18– 65 years who are switching or initiating new immunotherapy Objective: Examine the relationship between lesion sites in treatment are offered participation and complete informed patients with multiple sclerosis (MS) and specific categories of consent. Participants are then randomized to one of the two sleep disorders (SDs). Background: Increasing evidence intervention groups or placebo and are followed for 1 year. suggests that SDs may be more prevalent in MS, with small The primary endpoint is immunotherapy treatment adherence. studies reporting an association between specific brain

International Journal of MS Care 28 Posters regions and various types of sleep disturbances. Design/ patients at 96 weeks (last observation carried forward Methods: After a retrospective query of the Veterans Health [LOCF]; primary endpoint) was 17.4%, versus 27.3% for Administration database from 1998 to 2006, 940 patients REGARD, 21.4% for EVIDENCE, and 24.3% for a pooled with MS and SD were identified. A total of 206 patients were estimate with a fixed-effects model of both comparator stud - randomly selected for analysis of MS subtype, magnetic reso - ies. An a posteriori sensitivity analysis with an alternative nance imaging T2 lesion localization, and demographic vari - imputation method to LOCF for missing values, to account for ables. The χ2 test was used to examine differences between variations between studies in the proportion of patients miss - groups. Logistic regression was used to compute adjusted ing a week-96 assessment, estimated the proportion of NAb- odds ratios (ORs). Results: In all, 175 men (mean age positive patients at week 96 to be 18.9%, versus 28.3% for 52.0 ± 11.2 years) and 31 women (mean age 46.0 ± 9.8 REGARD and 23.9% for EVIDENCE. The proportion of NAb- years) with MS and SD were included in the analysis. Thirty- positive patients at any time during 96 weeks was 18.9%, nine percent of women and 24% of men had more than one versus 33.7% for REGARD, 27.1% for EVIDENCE, and type of SD ( P = .08). Lesions in the area of the primary and 30.4% for a pooled estimate of both comparator studies. supplementary motor cortices were associated with sleep- Conclusion/Discussion: Based on comparison with data Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 related movement disorders (SRMDs) (OR = 9.9; 95% confi - from the EVIDENCE and REGARD studies, Rebif New Formu - dence interval [CI], 5.07–19.2; P < .0001). Fifty-four percent lation has reduced immunogenicity compared with the current of relapsing MS patients had a coexisting SRMD, versus 19% Rebif formulation. of secondary progressive patients (OR = 4.8; 95% CI, 2.5– Gabriel Pardo, MD*; Olga Barbarash; Florence Casset-Semanaz; Gavin 9.3; P < .0001) and 28% of primary progressive patients Giovannoni; John King; Luanne Metz; James Simsarian; Per Soelberg (OR = 3.0; 95% CI, 1.1–8.3; P = .04). Patients with either Sorensen; Bettina Stubinski primary or secondary progressive MS were more likely to *Mercy NeuroScience Institute, Oklahoma City, OK, USA have either obstructive or central sleep apnea, although the Study supported by Merck Serono International S.A. association was not statistically significant ( P = .08). Sleep apnea was also associated with the presence of spinal cord (S61) Safety of Rebif New Formulation in lesions (OR = 1.9; 95% CI, 1.0–3.5; P = .046). Conclu - Relapsing Multiple Sclerosis sions/Relevance: SRMD can be associated with relapsing- Background: The tolerability and associated side effects of remitting MS and higher plaque burden near the primary and multiple sclerosis (MS) medications are important factors in supplementary motor cortices. Increased recognition and treatment adherence. Injection-site reactions (ISRs) are among treatment of patients susceptible to these disorders could have the most frequently reported local-tissue adverse events (AEs) a significant impact on disability and quality of life. There - associated with the administration of subcutaneous (SC) inter - fore, further studies of the specific risks associated with vari - feron β (IFN β) in MS. Rebif New Formulation is a new formu - ous SDs in the MS population are warranted. lation of SC IFN β-1a, produced without fetal bovine serum Olukemi Olugemo, MD*; Min Zhan, PhD; William Culpepper, MS; Christopher and without human albumin as an excipient, developed with Bever, MD; Mitchell Wallin, MD; Walter Royal III, MD the aim of improving tolerability and reducing immunogenici - *Baltimore VA Neurology Department, Baltimore, MD, USA ty. Objective: Investigate the safety and tolerability of Rebif Study supported by VHA MS Center of Excellence–East. New Formulation compared with historical (EVIDENCE study) and recent (REGARD study) data on the current Rebif formula - (S60) Immunogenicity of Rebif New Formulation in tion. Design/Methods: This was a phase 3b, 96-week, sin - Relapsing Multiple Sclerosis gle-arm, multicenter, open-label study of Rebif New Formula - Background: Interferon β (IFN β) treatment for multiple scle - tion (44 µg SC three times weekly) in patients aged 18–60 rosis (MS) can result in the development of neutralizing anti - years with relapsing MS and an Expanded Disability Status bodies (NAbs). The clinical relevance of NAbs has been Scale score <6.0. Prespecified categories of AEs commonly unclear, but high titers have been associated with decreased or occasionally associated with IFN β-1a were summarized IFN β efficacy. Rebif New Formulation is a new formulation of and analyzed by combining preferred terms. Results: ISRs, IFN β-1a that is produced without the use of fetal bovine which include injection-site pain, irritation, and erythema, serum and is without human albumin as an excipient in the were reported by 30.8% of patients, versus 85.8 and 41.2% formulation, with the aim of reducing immunogenicity and in the EVIDENCE and REGARD studies, respectively. Flulike improving tolerability while maintaining efficacy. Objective: symptoms were reported by 71.5%, versus 49.0 and 36.0%. Investigate the immunogenicity of Rebif New Formulation Depression/suicidal ideation was reported by 6.5%, versus compared with historical (EVIDENCE study) and recent 22.7 and 9.4%. Other prespecified categories of AEs were (REGARD study) data on the current formulation of Rebif. reported by similar proportions of patients compared with the Design/Methods: This was a phase 3b, 96-week, single- EVIDENCE and REGARD studies. Most patients experiencing arm, multicenter, open-label study of Rebif New Formulation AEs reported events of mild or moderate severity. Serious AEs (44 µg subcutaneously three times weekly) in patients aged (reported by 5.8% of patients) were similar to those in the 18–60 years with relapsing McDonald MS and an Expanded EVIDENCE (8.6%) and REGARD (7.6%) studies. There were Disability Status Scale score <6.0. Serum NAb status was no unexpected findings on assessments of liver enzymes or determined at baseline and regular intervals thereafter: ≥20 hematology; most recorded enzyme elevations and cytope - neutralizing U/mL (virus cytopathic effect assay) was consid - nias were of low toxicity grade (based on common terminolo - ered positive. Results: The proportion of NAb-positive gy criteria for AEs). Conclusion/Discussion: Rebif New

International Journal of MS Care 29 Posters

Formulation has an overall improved safety profile compared life and well-being in individuals with MS consistent with the with the current formulation of Rebif. ideals of medical humanities. Methods: We designed and Gabriel Pardo, MD*; Olga Barbarash; Florence Casset-Semanaz; Gavin implemented the workshop series in which participants per - Giovannoni; John King; Luanne Metz; James Simsarian; Per Soelberg formed writing exercises and experimented with different writ - Sørensen; Bettina Stubinski ing techniques. Participants read and analyzed models of cre - *Mercy NeuroScience Institute, Oklahoma City, OK, USA ative nonfiction and produced pieces to share with each Study supported by Merck Serono International S.A. other. Some participants wrote extensively of their MS experi - ences, and others chose different topics. All participants (S62) Cognition Impairment in Multiple Sclerosis worked at their own pace. Results: The 12-week workshop Study: 2- and 3-Year Results produced an anthology of collected writings, which we look Background: Decline in cognitive function occurs in 40– forward to distributing to academic libraries and MS centers. 65% of patients with multiple sclerosis (MS) and may be relat - The pilot program has grown and transformed into a self- ed to lesion load. Objective: Compare the effect of two sustained autonomous monthly program called The Coffee

doses of interferon β (IFN β)-1a on cognitive function and dis - Shop Meetings, attended by the original participants, coau - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 ease progression in patients with early relapsing-remitting MS thors, and new members. Conclusion: In keeping with the (RRMS). Design/Methods: The COGIMUS study is a philosophy of medical humanities that humanistic disciplines prospective multicenter, observational, dose-controlled study foster self-awareness and empathy, we seek to promote inter - that recruited patients aged 18–50 years with RRMS (McDon - disciplinary work within the field of medicine. This pilot pro - ald criteria) who had received IFN β-1a 22 or 44 µg subcuta - gram is a successful model of a unique interdisciplinary neously three times weekly for ≥3 months. Patients were eval - approach, linking the humanities and medical care to pro - uated clinically at baseline and every 6 months for 3 years. mote positive patient outlook. Based on our results, we are Complete neurological examination and Rao’s battery of now planning a study using outcome measures to collect data seven neuropsychological tests were performed at baseline and analyze effectiveness. Our writing program designed for and annually. Results: Of 459 patients recruited, 213 individuals with MS suggests that different disciplines can received IFN β-1a 22 µg and 246 received the 44- µg dose. work together creatively to improve patients’ quality of life. At 2 years, cognitive impairment, as measured in two or Amy Rauchway, DO; Abby Miller Lockett, MA more tests, developed in a significantly smaller proportion of St. Louis University, St. Louis, MO, USA patients receiving IFN β-1a 44 µg (48 of 171, 28.1%) versus Study supported by the Multiple Sclerosis Foundation. 22 µg (61 of 156, 39.1%; P = .035). Preliminary 3-year effi - cacy analysis is based on data from 304 of 363 patients (S64) Recurrent Aminotransferase Elevations After who completed 3 years of treatment; 199 received the 44- µg Treatment With Natalizumab µ and 164 received the 22- g dose. Overall, 222 of 304 Background: Drug-induced liver injury is a diagnosis of patients (73%) were relapse free over 3 years. Of the remain - exclusion that includes recognizing a clinical drug signature. ing 82 patients, 58 (20%) experienced one relapse, 21 (7%) Factors include the pattern (hepatocellular injury vs cholestatic experienced two relapses, 14 (5%) experienced three relaps - injury vs mixed) of liver test abnormalities, latency to presen - es, 4 (1%) experienced four relapses, and 3 (1%) experi - tation, hypersensitivity, and response to drug withdrawal. In enced five relapses. The annualized relapse rate was 0.19. the natalizumab phase 3 trial, abnormal liver function tests Sustained Expanded Disability Status Scale progression (1 (LFTs) were similar in the treatment and placebo groups (5 vs step confirmed over 6 months) occurred in 45 patients (15%). 4%, P = .406). Infusion reactions included any adverse event Data on 3-year cognition, additional clinical efficacy data, within 2 hours of infusion. Hypersensitivity reactions included magnetic resonance imaging, and safety will be presented. hypersensitivity, allergic or anaphylactic/anaphylactoid reac - Conclusion/Discussion: This is the first study to show a tion, urticaria, allergic dermatitis, or hives. Objective: dose-dependent reduction in the development of cognitive Report a case of acute drug-induced liver injury after each of β impairment with IFN -1a and supports early initiation of ther - two successive infusions of natalizumab. Methods: LFTs apy in MS. were monitored on a 53-year-old woman with multiple sclero - Francesco Patti*; Maria Pia Amato; Maria Rosalia Tola; Maria Trojano; sis (MS) and epilepsy who developed muscle tightness, Paolo Ferrazza; Orietta Picconi; Stefano Bastianello slurred speech, and weakness within hours of the fourth and *University of Catania, Catania, Italy fifth natalizumab infusions. Nausea also developed after infu - Study supported by the European Biomedical Foundation. sion five. Symptoms resolved by the next day. The pattern of liver injury was calculated. Additional laboratory tests and (S63) Benefiting Lives Through Writing: magenetic resonance imaging (MRI) were done. Results: Interdisciplinary Approach to Quality of Life Baseline liver functions were normal. Alanine aminotrans - Background: The St. Louis University Department of Neurol - ferase (ALT) at >10 times the upper limit of normal after infu - ogy & Psychiatry Multiple Sclerosis (MS) Center in collabora - sions four (480 U/L) and five (632 U/L) with slightly elevated tion with the St. Louis University English Department offered a alkaline phosphatase after infusion five indicated a pattern of 12-week creative writing workshop series supported by a acute hepatocellular injury. ALT decreased by half 2 days Multiple Sclerosis Foundation Quality of Life Grant. The inspi - after infusion four and normalized 3 weeks later each time. ration for the series stemmed from Taproot Workshops and Phenytoin and lamotrigine were discontinued before infusion Journal Inc., a well-known not-for-profit organization for elder five. Serologies were positive for natalizumab antibodies and writers in the New York area. Objective: Improve quality of negative for autoimmune or infectious causes of liver disease.

International Journal of MS Care 30 Posters

MRI of brain after infusion four was unchanged from base - D3 (DH-VD3), and T regulatory (Treg)–cell percentages in line. Conclusion: This patient’s liver injury was notable for patients with multiple sclerosis (MS). Background: Vitamin short latency and resolution of liver test abnormalities after D can lower the risk of developing MS, and Treg cells can withdrawal of natalizumab and is thus consistent with drug- suppress MS disease activity. H-VD3 levels reflect total vitamin induced liver injury. This case highlights the need to under - D stores, whereas DH-VD3 is the active form of vitamin D and stand the risk factors and mechanisms that may lead to liver is produced from H-VD3. The possible associations between injury in individuals with MS. vitamin D and specific T-cell subsets have not been previously Amy Rauchway, DO; Alex Befeler studied. Design/Methods: Serum samples obtained from St. Louis University, St. Louis, MO, USA 25 MS patients were examined by enzyme immunoassay for H-VD3 and DH-VD3. Treg-cell percentages in whole blood (S65) Decreased N-Acetylaspartate Resonance in were determined by staining the samples with fluorochrome- Hypothalamus of Multiple Sclerosis Patients labeled antibodies and subsequent flow cytometric analysis Background: At autopsy, demyelinating lesions in hypothal - for CD3+, CD4+, CD25+, and FoxP3+ T (Treg) cells. The amus were found in 15 of 16 multiple sclerosis (MS) patients data obtained were then examined with linear regression Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 studied. Activated microglial and macrophages suppressed analysis to determine correlations between H-VD3 and DH- Results: activity of corticotropin-releasing hormone producing neurons VD3 measurements and Treg-cell percentages. Mean + standard error levels of H-VD3, DH-VD3, and Treg- controlling the hypothalamic-pituitary-adrenal axis. In individ - cell percentages were, respectively, 85.3 + 7.8 nmol/L (nor - ual MS patients presenting breakthrough symptoms on mal, 15–150 nmol/L), 103.5 + 8.4 pmol/L (normal, 39–193 monotherapy with interferon β (INF β)-1a intramuscularly or pmol/L), and 2.3 + 0.3% (normal, 5–10%). No correlation subcutaneously, an added-on physiologic dose of prednisone was noted for the raw vitamin D measures and Treg-cell per - resulted in significant reduction in annualized relapse rate centages. However, mild correlations were noted between compared with individuals undergoing brief treatment with Treg-cell percentages and DH-VD3/H-VD3 ratios ( P = .03; glucocorticoids. Magnetic resonance imaging with T3 mag - R = 0.43) in this patient group. Conclusion/Discussion: net may reveal subclinical hypothalamic involvement in ~20% Treg percentages were lower than expected based on of MS patients. Objective: Use proton magnetic resonance preestablished norms. Effects of vitamin D may play a signifi - spectroscopy (MRS) to determine neuronal integrity in hypo - cant role in suppressing disease activity in patients with MS, thalamus of MS patients. Methods: With T3 MRS in 16 with such actions in part potentially mediated through effects patients with relapsing-remitting MS with Expanded Disability on Treg cells. Status Scale (EDSS) scores ≤2.0, 13 with secondary progres - sive MS with EDSS ≥5.5 (10 men and 19 women), and 12 Walter Royal III, MD; Younus Mia, PhD; Huifen Li, PhD healthy control subjects (6 men, 6 women), the area of hypo - University of Maryland School of Medicine, Baltimore, MD, USA thalamus was examined. Results: Our preliminary results Study supported by the National MS Society and EMD Serono, Inc. showed decreased N-acetylaspartate/creatin ratio (NAA/Cr) in individuals with EDSS ≥5.5 compared with EDSS ≤2.0 (S67) Progression of Disability Over 2 Years (1.6 ± 0.20 to 1.8 ± 0.35; P = .0282) and comparing Predicts Disability at 8 Years in Relapsing Multiple patients with EDSS ≥5.5 with control subjects (1.8 ± 0.28; Sclerosis: Analysis of Patients From MSCRG Study P = .0386). No significant difference between MS patients Worsening by 1 point on the Expanded Disability Status with EDSS ≤2.0 and control subjects and examination of the Scale (EDSS) sustained for 6 months was the primary end - choline/creatin ratio were established. Discussion: Trend point in the pivotal phase 3 clinical trial (MSCRG study) of toward reduction of NAA/Cr in patients with EDSS ≥5.5 sup - intramuscular interferon β-1a (IM IFN β-1a). However, limited ports the reported observation of faster clinical progression in data exist on the relationship between disability classified in individuals with more active hypothalamic lesions. Conclu - this way and future, clinically relevant disability. A post hoc sions: Further studies with automatic quantification of proton analysis was conducted to assess the relationship between MRS in larger populations of MS patients are warranted and sustained progression in EDSS score over 2 years and EDSS in progress. In individual MS patients, established subclinical score at 8 years in patients with multiple sclerosis (MS). Posi - reduction of hypothalamic neurons will alert clinicians to con - tive predictive values (PPVs) were calculated to determine the sider supplementation of adrenal and/or sex hormones to relationship between progressor status in the clinical trial and optimize clinical results of the ongoing treatment. future clinically relevant EDSS milestones. The analysis includ - Karen Rodman, MD*; Michael A. Kuharik, MD; Younghao MA, MD, PhD; ed 160 patients who received 2 years of treatment in the Clare A. Braun Hashemi, MD; Margaret L. Frazer, MD; Oldrich J. Kolar, MD, MSCRG study and were reexamined ≥8 years after random - PhD; Heidi Lee, MD ization (93% of potentially eligible subjects). Progressors dur - *Indiana Center for MS, Indianapolis, IN, USA ing the clinical trial ( n = 45) were significantly more likely Study supported by a grant from Pfizer Inc. and EMD Serono, Inc. than nonprogressors ( n = 115) to reach EDSS milestones ≥4.0, ≥5.0, ≥6.0, and ≥7.0 at 8-year follow-up (all P < (S66) Serum 1,25-Dihydroxy- and .001), even after adjusting for treatment assignment and 25-Hydroxyvitamin D Ratios Correlate With baseline EDSS (all P < .001). Compared with placebo, Peripheral Blood Regulatory T-Cell Percentages patients treated with IM IFN β-1a were significantly less likely in Patients With Multiple Sclerosis to progress to EDSS ≥4.0 ( P = .007) or ≥5.0 ( P = .010). After Objective: Examine associations between measurements of progression was confirmed, 11 of 45 cases (24%) improved serum 25-hydroxyvitamin D3 (H-VD3), 1,25-dihydroxyvitamin to a lower EDSS score. Patients who did not improve demon -

International Journal of MS Care 31 Posters strated higher PPVs than those who did, although the overall treatment of multiple sclerosis (MS). It produces a physiologi - predictive value of progression remained the same. PPVs of cal and neural response in patients. Objective: Evaluate progressor status over 2 years were not different across treat - whether symptoms improve after the acupuncture process. ment and baseline EDSS (all P > .05). Progressor status in the Methods: This was a retrospective study of 124 patients (22 MSCRG study was a meaningful predictor of future clinically men, 102 women) treated once a week for 12 weeks from significant disability. IM IFN β-1a reduced the probability of 2006 to 2007. They were between 22 and 67 years old. reaching clinically relevant EDSS milestones 4.0 and 5.0 at 8 The disability score was measured by the Kurtzke Expanded years. Disability Status Scale (EDSS) at the beginning and end of the Richard A. Rudick, MD*; Jar-Chi Lee, PhD; Robert A. Bermel, MD; Bianca treatment. Improvement of symptoms was evaluated by the Weinstock-Guttman, MD; Dennis Bourdette, MD; Carlo Tornatore, MD; Hao Verbal Analogical Scale (scores 0 –10) at the end of the pro - Zhang, PhD; Xiaojun You, PhD; Robert Hyde, PhD gram. The symptoms were insomnia (14.5%), urinary *Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic urgency (22.5%), nicture (4.8%), urinary retention (4.8%), Foundation, Cleveland, OH, USA urinary incontinence (5.6%), neuropathic pain (20.96%), and Study supported by Biogen Idec, Inc.

skeletal muscle pain (52.41%). Results: The EDSS average Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 (S68) Impact of Intramuscular Interferon β-1a of 4.19 did not change. Symptoms that improved <30% (Avonex) on Quality of Life in Patients With were insomnia, 16.66%; urinary urgency, 10.7; nicture, 0%; Relapsing Multiple Sclerosis urinary retention, 66.6%; urinary incontinence, 42.82%; neu - ropathic pain, 30.77%; skeletal muscle pain, 10.77%. In the pivotal phase 3 clinical trial of intramuscular interferon Improved between 40 and 60% were insomnia, 27.77%; uri - β β -1a (IM IFN -1a, Avonex) 30 g once weekly (MSCRG nary urgency, 17.86%; nicture, 16.6%; urinary retention, study), one of the preplanned objectives was to evaluate the 33.3%; urinary incontinence, 14.3%; neuropathic pain, β effects of IM IFN -1a on patient health-related quality of life 7.70%; and skeletal muscle pain, 10.77%. Improved >70% (QOL). QOL was measured in 275 patients with the patient were insomnia, 11%; urinary urgency, 71.43%; nicture, self-reported Sickness Impact Profile (SIP) administered at 83.3%; urinary retention, 0%; urinary incontinence,42.86%; baseline and every 6 months. It was hypothesized a priori neuropathic pain, 6.15%; and skeletal muscle pain, 78.46%. that patients with poorer baseline QOL would show improve - Conclusion: Acupuncture might be an effective alternative β ment with IM IFN -1a treatment. Hence, patients were strati - for improving the symptoms of MS. It can better quality of life, fied into two groups according to baseline SIP score (intact although it does not remove the disability measured by EDSS. QOL [SIP score <10] or poorer QOL [SIP scores 10]). A total Liliana Russo, MD; Maria Giacomo, MD of 158 patients (IM IFN β-1a , n = 81; placebo, n = 77) com - pleted the SIP at both baseline and 2 years. Baseline disease Brazilian Multiple Sclerosis Society, Sao Paulo, Brazil Study supported by the Brazilian MS Society. characteristics and SIP scores were similar between treatment arms among patients with SIP scores <10 (IM IFN β-1a, n = (S70) Maintaining Long-Term Motivation in 51; placebo, n = 43) and 10 (IM IFN β-1a, n = 18; placebo, Patients With Multiple Sclerosis n = 34). Overall, SIP scores were positively associated with Expanded Disability Status Scale (EDSS) scores; patients with Background: Self-injected disease-modifying therapies disability progression (defined as an increase in EDSS of ≥1 (DMTs) for relapsing multiple sclerosis (MS) have been shown point sustained for 6 months) demonstrated a significant wors - to reduce relapses and inflammation and in some cases delay ening in the physical dimension of SIP compared with disability. Consistent use of treatment is necessary to achieve patients who did not experience disability progression (0.06 positive outcomes. However, patients often lose motivation vs 4.19; P = .031). Trends toward significance were seen for and exhibit a decline in adherence to therapy. A better under - the overall SIP scores and psychosocial dimension scores. In standing of the reasons for declining patient motivation and IM IFN β-1a–treated patients with poorer baseline QOL (SIP nonadherence may help MS health care professionals (HCPs) ≥10), a statistically significant improvement in the physical successfully promote long-term adherence. Objectives: Iden - dimension score was seen at 2 years compared with place - tify the most common reasons for declines in motivation bo-treated patients (3.57 vs –3.78; P = .045), and trends and adherence to DMTs, and explore patients’ perspective toward significance were seen for the overall SIP score and on potential ways to overcome these declines. Design/ the psychosocial dimension score. This analysis provides fur - Methods: Data were obtained from the following sources: ther evidence that disease severity is associated with poorer MS therapy discontinuation records from the MS LifeLines pro - β QOL and demonstrates that treatment with IM IFN -1a signifi - gram (third quarter 2007; n = 840) and polling questions cantly improves QOL in patients with poorer baseline QOL and patient discussion obtained from an MS patient am - scores. bas sadors meeting held in August 2007. Results: The Richard A. Rudick, MD*; Pamela Foulds, MD; Xiaojun You, PhD most common reasons for therapy stoppage according to *Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic discontinuation records were adverse events (AEs; 7%), liver Foundation, Cleveland, OH, USA enzyme abnormalities (7%), and worsening MS symptoms Study supported by Biogen Idec, Inc. (7%). Of the MS ambassadors queried, 53% (28 of 52) felt that severity and frequency of AEs are key factors affecting (S69) Use of Acupuncture in Multiple Sclerosis adherence, and 42% (23 of 55) believed that reminders and Patients: Retrospective Review information about their therapy are the best ways to maintain Introduction: Acupuncture has been used for 2500 years motivation and adherence. A small group of ambassadors felt to treat diseases. It is safe and can be an effective tool in the that nurses are viewed as being the most supportive HCPs in

International Journal of MS Care 32 Posters maintaining motivation and treatment adherence. In patients’ and the predilection of lesions clinically and pathologically opinions, physician participation in patient care, physician for the spinal cord. Pertussis toxin (Ptx) enhances autoimmuni - reinforcement, discussions about current MS therapies, injec - ty by increasing expression of adhesion molecules, directly tion technique retraining, and patient support programs all facilitating infiltration of lymphocytes. To determine whether help maintain patient motivation. Conclusion/Discussion: we could relocalize T-cell infiltration and demyelinating Maintaining motivation is an important factor in keeping lesions to the brain, we injected Ptx into the cerebral ventricle patients adherent to therapy. Active involvement by physi - of mice after EAE induction. Methods: We adapted a cians, nurses, and patient support programs is important in murine model of myelin oligodendrocyte glycoprotein-induced maintaining motivation and treatment adherence in patients EAE. We then injected Ptx into the cerebral ventricle to study receiving long-term treatments for relapsing MS. the clinical and pathological difference in brain versus spinal Jo Scanzillo, RN, MSCN*; Kathleen Costello, MS, CRNP; Patricia Kennedy cord. Results: We demonstrate the subsequent T-lymphocyte *EMD Serono, Inc., Rockland, MA, USA infiltration and white matter myelin loss with relative axonal Study supported by EMD Serono, Inc., and Pfizer Inc. sparing evidenced in the brain, which bear similarities to

white matter plaques seen in MS. Remarkably, intracere - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 (S71) Satisfaction and Side Effects: Relative Ratings broventricular Ptx, while increasing infiltration of lymphocytes of Antidepressants by Multiple Sclerosis Patients in the brain, attenuated the clinical and pathologic effects on Background: Although multiple sclerosis (MS) patients are the spinal cord, providing evidence of chemotactic diversion. frequently treated with antidepressant medications (AMs), few Interpretation: Our pathological observation confirms the studies have examined the efficacy and side effects of AM in development of a novel brain model of autoimmune dis - patients with MS. Objective: Increase our understanding ease/MS. The attenuation of the spinal lesion suggests a about the efficacy of and satisfaction with frequently pre - model in which chemotactic diversion may be protective. scribed AMs in MS patients. Design/Methods: A semiran - Jiong Shi, MD, PhD*; Chong-bo Zhao, MD, PhD; Stephen W. Coons, MD; dom sample of patients seen in the Allegheny MS clinic Mei Cui, MD, PhD; Fu-dong Shi, MD, PhD; Sandra M. Kuniyoshi, MD, PhD between February 2007 and January 2008 were asked to *Barrow Neurological Institute, Phoenix, AZ, USA complete AM surveys. Patients were provided with a list of Study supported by Barrow Neurological Foundation. AMs and rated those they felt they could confidently rate with regard to efficacy and side effects. They rated up to three cur - (S73) Tolerability of New Formulation of β rent AMs and up to three past AMs. Results: A total of 111 Subcutaneous Interferon -1a Versus β patients completed ratings. Fifty-nine (53%) rated at least one Interferon -1b current and 50 (45%) rated at least one past medication, Background: Effective and well-tolerated therapies, such as yielding a total of 127 ratings. Medications (number of rat - interferon β (IFN β), have been available for the treatment of ings) rated >10 times included escitalopram oxalate (24), multiple sclerosis (MS) for more than a decade. Clinical trials venlafaxine (19), fluoxetine (17), sertraline (16), and bupro - have shown that subcutaneous (SC) administration of high- prion (14). Analysis of variance and χ2 analysis were used to dose, high-frequency IFN β is more effective than intramuscu - test for differences between these AMs only. Significant differ - lar administration of once-weekly IFN β. Data suggest that a ences were found in average ratings of efficacy for sleep and new formulation of IFN β SC, recently approved in Europe mood swings between medications. Escitalopram oxalate and Canada and currently under review by the US Food and received the lowest and sertraline received the highest aver - Drug Administration, has an improved local tolerability pro - age rating for helping with sleep, whereas buproprion file. Objective: The Rebif New Formulation Versus Betaseron received the lowest and sertraline and fluoxetine received the Tolerability study was designed to compare the tolerability of highest average ratings for helping with mood lability. No the new formulation of IFN β-1a SC with that of IFN β-1b SC. significant differences were found in ratings of efficacy for Design/Methods: This is a 12-week, open-label, multicen - sadness, irritability, memory, fatigue, pain, emotional inconti - ter study that included patients with relapsing-remitting MS, nence, anxiety, overall satisfaction, incidence of side effects, aged 18–60 years, who were naive to IFN treatment. or intensity of side effects. Conclusion/Discussion: Prelimi - Patients were randomized in a 1:1 design to receive the new nary data suggest that patients tended to report little differ - formulation of IFN β-1a 44 µg SC three times weekly or IFN β- ence in efficacy for most target symptoms or side effects 1b 250 µg SC every other day for 12 weeks. This will be fol - among these frequently used agents, although different AMs lowed by the option to participate in a safety extension. The may be more or less helpful with specific symptoms such as primary endpoint for the study is the mean change in pain mood lability and sleep. score, reported on a visual analog scale, from preinjection to Carol Schramke, PhD; Kelly Manning, MD; Thomas F. Scott, MD; 30 minutes postinjection over the first 21 injections of full- Carol Chieffe, RN dose IFN β-1a (weeks 5–11) and IFN β-1b (weeks 7–12). Sec - Allegheny General Hospital, Pittsburgh, PA, USA ondary measurements include injection-site redness (evaluat - Study supported by Allegheny General Hospital. ed by blinded assessor), patient-reported Short-Form McGill Pain Questionnaire, MS Treatment Satisfaction Questionnaire, (S72) Novel Animal Model of Multiple Sclerosis by documentation of relapses, safety, and tolerability (assessed Pertussis Toxin–Induced Chemotactic Diversion vs historical studies). Results: Enrollment included 127 Objective: The experimental autoimmune encephalomyelitis patients (mean age 41 years, 70% women, 87% white), with (EAE) model represents pathologies seen in multiple sclerosis 27% ( n = 34) meeting diagnostic criteria for MS. Final results (MS), but it manifests a relative absence of brain pathology at 12 weeks will be presented. Conclusion/Discussion:

International Journal of MS Care 33 Posters

This study provides comparative tolerability and safety among veterans and caregivers. Design/Methods: This data of a new formulation of SC IFN β-1a versus IFN β-1b in was an observational study of routine clinical care using relapsing MS. home telehealth devices with veterans ( n = 33) and care - Barry Singer, MD*; Chris Sheppard, MD; Steven Glyman, MD; John givers ( n = 12) from VA outpatient MS clinics in Seattle, WA; Huddlestone, MD; Randy Schapiro, MD; Myassar Zarif, MD; Patricia Baltimore, MD; and Washington, DC. Veterans answered Blake, RN; Randy Bennett; Ahmad AL-Sabbagh, MD text-based questions for 1–6 months (January 2006 through *Barnes-Jewish Hospital, St. Louis, MO, USA May 2007). Questions included MS symptoms, pain, fatigue, Study supported by EMD Serono, Inc., and Pfizer Inc. bowel, bladder, depression, and disease-modifying therapies and used branching logic in response to current symptoms. (S74) What Is the Natural History of Oligoclonal Answers were coded according to severity level (high, medi - Band–Negative Multiple Sclerosis Patients? um, low) and flagged in a computerized patient chart. Pre- Background: Being oligoclonal band negative (OCB–) has and postquestionnaires were mailed to a subsample of veter - been suggested to be associated with a milder disease ans and caregivers to assess veteran disability status (Expand -

course. Objective: Review the natural history of OCB– cere - ed Disabilities Status Scale –Self), quality of life (SF-12), and Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 brospinal fluid (CSF) multiple sclerosis (MS) patients via caregiver burden and stress (Caregiver Strain Index and Zarit demographic and clinical data. Methods: This was a retro - Burden Scale). Patient satisfaction, health care practices spective study of 450 MS patients, at a large academic MS (provider response type/time to intervention), and service uti - center, who had reliable CSF results in their database (IMED) lization (numbers/types of encounters, telehealth costs) will from analysis performed after 1 January 1993 and followed be examined . Results: To date, almost half (45%) of partici - up to 1 November 2007. Results: Only 41 (9.1%) out of pants endorsed MS symptoms at a medium-to-high severity 450 MS patients, all meeting current diagnostic criteria, were level: 13% high, 32% medium, and 55% low. Of high alerts, CSF OCB–. The mean age at onset was 36.40 ± 9.06 years fatigue-related alerts were most frequently reported (35%). A (16–58 years), and the female-to-male ratio was 1.73. The subsample of veterans ( n = 16; mean 3.440 [standard devia - subsequent course for this group was primary progressive MS tion 0.964]) and caregivers ( n = 12; 2.830 [0.937]) report - in 19.5% ( n = 8), secondary progressive MS in 14.6% ( n = ed that they generally liked using home telehealth (5-point sat - 6), relapsing-remitting MS in 63.4% ( n = 26), and progres - isfaction scale: 1 = poor to 5 = excellent). Conclusion/ sive relapsing MS in 2.4% ( n = 1). First location manifesta - Discussion: Veterans and caregivers participated in and tions were brain stem/cerebellum in 21.1%, cord in 26.3%, were satisfied with a home telehealth intervention. MSCOE is optic nerve in 15.8%, supratentorial in 34.2%, and multifocal adapting the question set and information from this study for involvement in 2.6%. The IgG index was 56.46 ± 10.26 use in VA home telehealth programs nationwide. We antici - (34–82; n < 70). Clinical follow-up indicated a mean number pate that data from this study will inform intervention and edu - of relapses for this group of 2.49 ± 2.28 (0–9), regardless of cation efforts. treatment. In comparison with the OCB+ patients ( n = 409), Alicia Sloan, MPH, MSW*; Aaron Turner, PhD; Richard Buhrer, MN, ARNP, the only significant differences in demographics was the site CRRN-A; Lore Martz, RN; Robert Kane, PhD, ABPP-Cn; Mitchell Wallin, MD, of first presentation in the OCB+ group: brain stem/cerebel - MPH; Heidi Maloni, PhD, NP; Jodie Haselkorn, MD, MPH lum in 18%, cord in 43.5%, optic nerve in 23%, supratentori - *Multiple Sclerosis Center of Excellence (MSCOE)–West, VA Puget Sound Health al in 8.5%, and multifocal involvement in 7.1% ( P < .0001). Care System, Seattle, WA, USA Study supported by VA MSCOE. There was a trend toward significantly fewer attacks in the OCB+ group, 1.59 ± 2.05 (0–14; P = .058). No differences (S76) Does Increase in Symptoms Predict were seen in the Expanded Disability Status Scale score. Reduction in Physical Activity Across Time in Conclusion: OCB – patients have many similar characteris - Multiple Sclerosis? tics to patients who are OCB+, but differences in the location of first presentation was of interest, with more supratentorial Background: Individuals with multiple sclerosis (MS) are and fewer optic nerve and spinal cord events. If anything, this substantially less physically active than nondiseased popula - group appeared to have slightly more relapse activity. The tions, and unique aspects of MS such as symptomology may data do not suggest that being OCB– is associated with more partially account for the rate of inactivity. We have demon - benign disease. strated that elevated symptomology is associated with lower Sasitorn Siritho, MD; Mark S. Freedman, MSc, MD, CSPQ, FAAN, FRCPC levels of physical activity participation in individuals with MS University of Ottawa, Ottawa, ON, Canada using cross-sectional research designs. The next step in this line of research involves examining change in symptoms as a (S75) Veterans Affairs Multiple Sclerosis Centers of predictor of change in physical activity across time. Pur - Excellence Home Telehealth Project pose: This study used a longitudinal research design and Background: Veterans Affairs (VA) Multiple Sclerosis Cen - examined the role of naturally occurring change in MS- ters of Excellence (MSCOE) are evaluating the suitability and related symptoms as a predictor of change in physical activity feasibility of telehealth technology to monitor and manage across time among individuals with MS. Methods: The sam - multiple sclerosis (MS) patients at home. Specific implementa - ple consisted of 172 individuals, ambulatory with or without tion uses a question set administered through home devices to aid, who had a definite diagnosis of MS. Participants com - assess pertinent symptoms and problems associated with MS. pleted three measures of MS-related symptoms (assessing Objective: Field test a standardized MS question set for symptom severity, frequency, and distress), answered a physi - symptom monitoring and management via home telehealth cal activity questionnaire, and wore an accelerometer for 1

International Journal of MS Care 34 Posters week. Data were collected at baseline and 6 months and ther long-term investigation of its effect on patient outcomes in were analyzed with a panel model within a covariance mod - a real-world setting. eling framework. Results: The panel model with latent vari - Judith Stephenson, SM*; Kitty Rajagopalan, PhD; Siddhesh Kamat, SM ables for symptoms and physical activity at baseline and *HealthCore Inc., Wilmington, DE, USA 6 months provided an excellent fit for the data ( χ2 = 29.94, Study supported by Biogen Idec Pharmaceuticals. df = 24, P = .19; root-mean-square error of approximation = 0.04; comparative fit index = 1.0). Within this model, a (S78) Novel Team-Based Approach to Helping cross-sectional association existed between symptoms and People With Multiple Sclerosis Obtain Social physical activity ( γ = –.39) and a longitudinal association Security Disability Benefits between change in symptoms and change in physical activity Background: People with multiple sclerosis (MS) are fre - β ( = –.43). Conclusion: Our findings suggest that an quently unable to work because of their neurological impair - increase in the burden of symptoms over a brief period is ments. Unfortunately, many people with MS have difficulty associated with a concomitant reduction in physical activity accessing their Social Security Disability Insurance (SSDI), and would support the development of intervention programs partly because the most frequently disabling symptoms—cog - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 that target symptom management as a means of promoting nitive problems and fatigue—are not carefully and objectively physical activity in people with MS. measured with standard neurological testing. Objective: Erin Snook, MS; Rachael Gliotonni, BS; Robert Motl, PhD Measure the effectiveness of a team-based approach to assist University of Illinois at Urbana-Champaign, Urbana, IL, USA people with MS with the SSDI application process. Meth - Study supported by the National Institute of Neurological Diseases and ods: We developed an individualized team-based approach Stroke (NS054050). to assist people with disability applications. In addition to general education about the application process, we referred (S77) Impact of Natalizumab on Patient Outcomes people to other specialists, including speech therapists or neu - in Multiple Sclerosis ropsychologists when cognitive problems were present and occupational therapists when fatigue was present. Critically, Objective: Assess multiple sclerosis (MS) patient-reported we also endeavored to have the content of the specialists’ experiences with natalizumab (Tysabri) in a real-world setting. reports supported by information in the medical record. Methods: MS patients who received their third natalizumab Results: Seventy people with MS participated in our pro - infusion and were enrolled in the manufacturer’s restricted dis - gram. Of these, 66 participants responded completely or par - tribution (TOUCH) program participated in a 20-minute cross- tially to a survey about the program. Overall, 57 claims were sectional Internet or telephone survey. Patient-reported meas - successful, 8 claims are pending review, and 1 person with - ures included an adapted version of the MS Impact Scale-29 drew her application. For the survey, we had complete (MSIS-29), pre/post disease level and functional status responses from 52 people. Of these respondents, 25 began scores, and prior MS drug use. MSIS-29 responses were our process before the initial application. Seventeen of these modified to measure patient-perceived change since initiating people (68%) were immediately successful. Of the remaining natalizumab. Paired t tests assessed pre/post changes in dis - 8 people, 4 were successful on appeal, and 4 are pending ease level and functional status, where positive change indi - appeal. Of the 27 who already had their claim denied cated improvement. Results: Results from 319 patients in before beginning our program, 21 (78%) were successful ≥ this ongoing survey (expected n 400) indicated that 75% during their appeal before an administrative law judge. Of were women and that, on average, patients were diagnosed the remaining 6 people, 5 have claims pending, and 1 with - with MS >11 years ago. Almost all (97%) patients used one drew. Conclusion: Through our team-based approach, at or more MS drugs before natalizumab. The most frequently least 68% of participants were immediately successful, which used drugs were interferon β-1a (Avonex) (67%), glatiramer is much greater than the rate of 30% for people in Colorado acetate (Copaxone) (49%), interferon β-1b (Betaseron) (36%), who apply with neurological problems generally. On appeal, and interferon β-1a (Rebif) (35%). Despite the short treatment our success rate was at least 78%, whereas that rate on a duration, significant improvements occurred in disease level national basis is ~16%. (0.30 ± 1.13; t = 4.78; P < .001) and functional status Thomas Stewart, JD, MS, PA-C; Patricia Daily, LCSW; Pat Kennedy, CNP, RN, (0.36 ± 0.80; t = 7.96; P < .001). MSIS-29 items with the MSCN; Angela Delbeck, PhD, OTR; Ruth Irvin, JD; Kris Couch, OTR; Allen greatest reported improvement since initiating natalizumab Bowling, MD, PhD were worries related to MS (66%), feeling unwell (64%), abil - Rocky Mountain MS Center, Englewood, CO, USA ity to do physically demanding tasks (63%), problems with Study supported by Teva Neuroscience. balance (61%), feeling mentally fatigued (61%), and difficul - (S79) Intrathecal Baclofen Complications and ties moving about indoors (60%). Items with the least reported Ambulation Status in Multiple Sclerosis improvement were tremors of arms or legs (49%), being stuck at home (49%), problems sleeping (49%), and problems Objective: Compare the rate and type of complications using transport (42%). On average, patients reported related to intrathecal baclofen (ITB) therapy between ambula - improvement on 13 (45%) MSIS-29 items. Conclusion: tory and nonambulatory multiple sclerosis (MS) patients. After only 3 months on natalizumab, patients reported Design: This study was a retrospective analysis of an institu - improvements on MSIS-29 items, disease level, and functional tional review board–approved spasticity registry. Participants status. Although preliminary, these early results are suggestive were from a spasticity clinic within an outpatient MS center of natalizumab’s beneficial effect on patients and warrant fur - and were MS patients with severe lower-extremity spasticity.

International Journal of MS Care 35 Posters

Methods: A programmable intrathecal infusion system was ses, an inverse trend between disability and number of live implanted for ITB therapy. The main outcomes measured were births (>1 pregnancy) was observed. In tests adjusted for age, sex, MS course, MS duration, ambulation status, num - age, the trend appeared stronger for age 45–54 years and ber of complications, and type of complications (catheter mal - fairly level for age 55–64 years. Conclusion: Parity as a function, pump malfunction, infection, other). Results: A total potential factor associated with long-term disability warrants of 124 patients (aged 49 ± 8 years, 68.5% women, disease further investigation. We will provide additional information duration 17 ± 9 years, disease course 89% progressive, whether these results might be confounded by earlier initia - duration of ITB therapy 4 ± 2 years) underwent surgery. Sixty- tion of disease-modifying therapy and timing of pregnancy in five patients (52%) were ambulatory. No statistically signifi - relation to disease onset. cant differences existed in demographic or disease parame - Barbara Teter, PhD, MPH*; Cornelia Mihai, MD; Allison Drake, MS; Brian ters between ambulatory and nonambulatory patients. Apatoff, MD; Christopher Christodoulou, PhD; Patricia Coyle, MD; Alfred Fron - Thirty-one patients (25%) developed at least one complica - tera, MD; Susan Gauthier, MD; Andrew Goodman, MD; Malcolm Gottesman, tion. Out of 48 complications, 69% were catheter malfunc - MD; Carl Granger, MD; Joseph Herbert, MD; Richard Holub, MD; Burk Jubelt, tion, 0% pump malfunction, 21% infections, and 10% other. MD; Lauren Krupp, MD; Nei Lava, MD; Michael Lenihan, MD; Fred Lublin, MD; Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Follow-up duration was significantly longer in the subgroup of Aaron Miller, MD; Frederick Munschauer III, MD; Nancy Nealon, MD; Paulette Niewczyk, PhD, MPH; Allan Perel, MD; Steven Schwid, MD; Mark Tullman, patients with complications ( P = .02). A significantly higher MD; Robert Zivadinov, MD, PhD; Bianca Weinstock-Guttman, MD incidence of catheter-related complications occurred in ambu - *NYSMSC, Jacobs Neurological Institute, Buffalo, NY, USA latory patients. ITB therapy was discontinued in 10% of the patients who had complications (all had an infection). Con - (S81) Cost of Multiple Sclerosis: Updated clusions: In our population of MS patients, most of the com - Review of Literature plications requiring surgery after ITB system implantation were related to catheter malfunction. Although ambulatory Background: Since the introduction of disease-modifying patients exhibited a higher risk of developing catheter-related therapies (DMTs) for the treatment of multiple sclerosis (MS), complications, none of those who experienced a complica - few articles have specifically examined the relationship tion discontinued therapy. This suggests that in the patients’ between costs and the level of disability in MS. Objective: judgment, the benefits of ITB still outweighed the temporary Update the review of the literature done by Patwardhan et al. negative impact of a system malfunction. regarding the costs associated with MS by level of disability. Darlene Stough, RN, MSCN, CCRP; Francois Bethoux, MD Methods: Patwardhan et al. completed a literature review Cleveland Clinic, Mentor, OH, USA of costs of MS up to the year 2002. An updated literature review was performed with similar search terms, including (S80) Parity Versus Nulliparity Association With multiple sclerosis and costs and cost analysis , economics , Long-Term Multiple Sclerosis Disease Progression and fees and charges . We examined cost categories includ - ing inpatient costs, outpatient costs, tests, drugs, services, Background: Although much attention has been devoted to the issue of a short-term effect of pregnancy on multiple scle - investments, informal care, and indirect costs. All costs were rosis (MS) disease activity, reports regarding the long-term inflated to 2007 USD with the consumer price index for US effect of pregnancy on disease progression and disability are medical care services. Costs for studies conducted outside of limited and conflicting. Evaluation of the differences between the United States were converted to 2007 currency with the parous and nulliparous women with longstanding MS may specific country’s inflation rate and then converted to US cur - provide critical insight regarding the influence of pregnancy rency. Studies included in the review examined costs associat - on MS. Objective: Explore whether long-term disability sta - ed with different levels of disability according to the Expand - tus measured with the Expanded Disability Status Scale ed Disability Status Scale (EDSS). Results: We identified 5 (EDSS) for women with MS is associated with the occurrence articles in addition to the 10 articles identified through 2002 and/or number of live births. Design/Methods: Analysis by Patwardhan et al. Average per-patient annual costs across was based on longitudinal data from the New York State Mul - all studies from 1966 to 2007 were as follows: US studies, tiple Sclerosis Consortium (NYSMSC) registry comprised of $13,941 (EDSS = 2) to $136,467 (EDSS = 8); European patients from 16 MS centers in New York State organized to studies, $24,121 (EDSS = 2) to $92,741 (EDSS = 8). Studies prospectively collect demographic and clinical data. Women completed before the introduction of DMTs documented lower aged ≥45 years were included in this analysis. Results: total costs associated with all disability levels. The costs of Data from 3038 women, 616 nulliparous (20.3%) and 2422 drugs, informal care, and indirect costs were the largest driv - parous (79.7%), were analyzed. The mean number of child - ers behind the cost of MS. Higher informal care and indirect births for parous women was 2, and mean age at most costs were associated with higher levels of disability. Con - recent visit was 54 years (standard deviation 7.4 years). In clusions: Annual per-patient costs for MS increase signifi - our sample, parous women were less likely ( P < .0001) to cantly with disability level. Therapies that can slow the pro - have higher education (university degree through postgradu - gression of disability may help to avoid the high costs ate) than nulliparous women. Overall, a statistically signifi - associated with more severe disease disability. cant difference between parity versus nulliparity and disability Adam Turpcu*; Elaine Yu, MS, PharmD level (EDSS ≥6) was observed, nulliparous patients having a *University of Southern California, Los Angeles, CA, USA higher disability level ( P < .0001). Also, in unadjusted analy - Study supported by Genentech.

International Journal of MS Care 36 Posters

(S82) Providing Optimal Care in Home and in ty increased with disease duration. Annual relapse rate was Facilities: Are We Hitting or Missing the Mark? highest (1.1) at 15 years disease duration and lowest (0.36) at 5 years. Annual rate of steroid-treated relapses ranged Background: The spectrum of continuing care extends from between 0.03 and 0.16. As expected, age-adjusted employ - the occasional need for therapy to residing in a long-term- ment rate was less than in the general population and care center. Although anecdotal reports exist on how well, or decreased with disease duration from 48 to 15%. Conclu - not well, we are meeting the continuing care needs of MS sion/Discussion: In this sample of currently untreated MS patients, minimal research data exist . Objective: The pur - patients, disease duration was associated with increased dis - pose of this study was to ascertain the current use of and sat - ability and corresponding steady decline in employment. Fur - isfaction with continuing care services among people with ther analyses are needed to assess the impact of lifelong MS. Methods: Forty-one MS patients living in their own treatment history and potential treatment failures on long-term homes in a metropolitan area, along with 27 people living in outcomes, including employment. either a supportive living facility or a long-term-care center, completed a self-report questionnaire. Results: Of those liv - Tuula Tyry, PHD*; Patricia Davis, MS; Timothy Vollmer, MD; Ruth Ann Marrie, MD, PHD; Gary Cutter, PHD; Denise Campagnolo, MD ing at home, 22.5% received some type of publicly funded Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 *Barrow Neurological Institute, Phoenix, AZ, USA home-care services within the past year. However, 48.5% said they had needed home-care services but did not receive (S84) Natural History of Multiple Sclerosis Among them. Similarly, 44.0% of those in supportive living or long- Patients Treated With Glatiramer Acetate term-care facilities indicated they had needed more services within the past year. For both the home-living and the support - Background: The course of multiple sclerosis (MS) is vari - ive/facility groups, the most needed services were physiother - able and unpredictable, complicating treatment decisions. apy (25.0 and 15.8%, respectively) and housework (21.9 Better understanding of its natural history within a specific and 21.1%). The most common reasons for not getting the treatment group could assist with treatment strategies and pro - needed services for those at home were 1) not knowing who vide guidance for clinical trial designs. Objective: We to call and 2) too long a wait. For the supportive/facility aimed to describe the natural history of MS in patients cur - group, the primary reason was being assessed for less servic - rently treated with glatiramer acetate. Design/Methods: es than they thought they required. Both groups expressed We queried the NARCOMS self-report registry for 1183 MS satisfaction with the services they had received in the past patients with ≥5 years of annual data who are currently treat - year and appreciation toward the staff. Both groups acknowl - ed with glatiramer acetate (Copaxone). The cohort was 78% edged the roles that staffing shortages and restricted women and 94% white, with average age 52.9 (standard resources play in being able to provide optimal care. Con - deviation 9.1) years, disease duration 15.2 (7.7) years, and clusions: With limited human and financial resources, wise Patient-Determined Disease Step (PDDS) 3.6 (2.4). We classi - use of funds is required to best meet the continuing care fied patients based on their most recent history on current needs of MS patients. This study gives the MS patients’ voice treatment (<4, 4 to <5, and >5 years) and calculated aver - in this regard. age PDDS, performance scale scores, relapse rate, and Karen V.L. Turpin, MSc, BScN*; Sharon A. Warren, PhD; Garry Wheeler, PhD, employment rate as a function of disease duration for each RPsych; Kenneth G. Warren, MD, FRCP(C) group. Results: PDDS increased with disease duration in all *MS Patient Care & Research Clinic, University of Alberta, Edmonton, AB, groups; the longest treatment duration was associated with Canada lower disability. Annual relapse rate was lowest (0.35–0.65) in the longest treatment group up to 20 years disease dura - (S83) Natural History of Multiple Sclerosis Among tion. The rate of steroid-treated relapses (0.12–0.16) was Currently Untreated Patients lowest in the longest treatment group up to 15 years disease Background: The course of multiple sclerosis (MS) is vari - duration. As expected, age-adjusted employment rate was able and unpredictable, complicating treatment decisions. less than in the general population and decreased with dis - Better understanding of its natural history within a specific ease duration. Longer treatment was associated with a lower treatment group could assist with treatment strategies and pro - rate of decline in employment. Conclusion/Discussion: In vide guidance for clinical trial designs. Objective: We this sample, longer treatment with glatiramer acetate aimed to describe the natural history of MS in patients cur - appeared to be associated with better outcomes. The effect rently untreated with any of the disease-modifying agents was at least partially due to selection bias, because the histo - (DMAs). Design/Methods: We queried the NARCOMS ry of previous therapy switches in the shortest treatment registry for 538 MS patients with ≥5 years of annual data group suggested a more severe disease course. Further who reported no DMA therapy for the past 5 years or longer. analyses are needed to assess the impact of lifelong treatment The cohort was 64% women and 95% white, with average history and treatment failures on long-term outcomes, includ - age 61.0 (standard deviation 9.7) years, disease duration ing employment. 22.6 (10.8) years, and Patient-Determined Disease Step Tuula Tyry, PhD*; Patricia Davis, MS; Timothy Vollmer, MD; Ruth Ann Marrie, (PDDS) 4.5 (2.4). We calculated average PDDS, perform - MD, PHD; Gary Cutter, PHD; Denise Campagnolo, MD ance scale scores, relapse rate, and employment rate as a *Barrow Neurological Institute, Phoenix, AZ, USA function of disease duration. Results: The average PDDS (S85) Natural History of Multiple Sclerosis Among level increased with disease duration (5–25+ years) from 3.4 Patients Treated With Intramuscular Interferon β-1a to 5.0. On average, depression remained at a minimal level, ranging from 1.1 to 1.3, whereas cognitive (1.1–1.6, mini - The course of multiple sclerosis (MS) is variable and unpre - mal to mild) and fatigue (2.3–2.8, mild to moderate) disabili - dictable, complicating treatment decisions. Better understand -

International Journal of MS Care 37 Posters ing of its natural history within a specific treatment group The longest treatment group had a higher employment rate could assist with treatment strategies and provide guidance up to disease duration of 15 years, but the overall rate of for clinical trial designs. Objective: We aimed to describe decline was similar in all groups. Conclusion/Discussion: the natural history of MS in patients currently treated with In this sample, longer treatment with SC interferon β-1a intramuscular (IM) interferon β-1a. Design/Methods: We appeared to be associated with better outcomes. The effect queried the NARCOMS registry for 919 MS patients with ≥5 was at least partially due to selection bias, because the histo - years of annual data who are currently treated with IM inter - ry of previous therapy switches in the shortest treatment feron β-1a (Avonex). The cohort was 78% women and 92% group suggested a more severe disease course. Further white, with average age 54.0 (standard deviation 9.0) years, analyses are needed to assess the impact of lifelong treatment disease duration 15.7 (8.3) years, and Patient-Determined history and treatment failures on long-term outcomes, includ - Disease Step (PDDS) 3.1 (2.3). We classified patients based ing employment. on their most recent history on current treatment (<4, 4 to <5, Tuula Tyry, PhD*; Patricia Davis, MS; Timothy Vollmer, MD; Ruth Ann Marrie, and >5 years) and calculated average PDDS, performance MD, PhD; Gary Cutter, PhD; Denise Campagnolo, MD *Barrow Neurological Institute, Phoenix, AZ, USA scale scores, relapse rate, and employment rate as a Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 function of disease duration for each group. Results: PDDS increased with disease duration in all groups; longer treat - (S87) Natural History of Multiple Sclerosis Among ment was associated with lower disability. In the longer treat - Patients Treated With Subcutaneous Interferon β-1b ment groups, annual relapse rate was between 0.35 and Background: The course of multiple sclerosis (MS) is vari - 0.65, and the rate of steroid-treated relapses was >0.2; rates able and unpredictable, complicating treatment decisions. were higher in the shortest treatment group. As expected, Better understanding of its natural history within a specific age-adjusted employment rate was less than in the general treatment group could assist with treatment strategies and pro - population and decreased with disease duration. Longer vide guidance for clinical trial designs. Objective: We treatment was associated with a lower rate of decline in aimed to describe the natural history of MS in patients cur - employment. Conclusion/Discussion: In this sample, rently treated with subcutaneous (SC) interferon β-1b. β longer treatment with IM interferon -1a appeared to be asso - Design/Methods: We queried the NARCOMS registry for ciated with better outcomes. The effect was at least partially 601 MS patients with ≥5 years of annual data who are cur - due to selection bias, because the history of previous therapy rently treated with SC interferon β-1b (Betaseron). The cohort switches in the shortest treatment group suggested a more was 77% women and 94% white, with average age 53.6 severe disease course. Further analyses are needed to assess (standard deviation 9.6) years, disease duration 15.9 (7.5) the impact of lifelong treatment history and treatment failures years, and Patient-Determined Disease Step (PDDS) 4.0 (2.3). on long-term outcomes, including employment. We classified patients based on their most recent history on Tuula Tyry, PhD*; Patricia Davis, MS; Timothy Vollmer, MD; Ruth Ann Marrie, current treatment (<4, 4 to <5, and >5 years) and calculated MD, PhD; Gary Cutter, PhD; Denise Campagnolo, MD average PDDS, performance scale scores, relapse rate, and *Barrow Neurological Institute, Phoenix, AZ, USA employment rate as a function of disease duration for each group. Results: PDDS increased with disease duration in all (S86) Natural History of Multiple Sclerosis Among groups; longer treatment was associated with lower disability. β Patients Treated With Subcutaneous Interferon -1a Annual relapse rate (0.53–0.80) and steroid-treated relapse Background: The course of multiple sclerosis (MS) is vari - rate (0.06–0.44) were lower in the longer treatment groups. able and unpredictable, complicating treatment decisions. As expected, age-adjusted employment rate was less than in Better understanding of its natural history within a specific the general population and decreased with disease duration. treatment group could assist with treatment strategies and pro - The longest treatment group had the highest employment rate, vide guidance for clinical trial designs. Objective: We but the overall rate of decline was similar in all groups. Con - aimed to describe the natural history of MS in patients cur - clusion/Discussion: In this sample, longer treatment with β rently treated with subcutaneous (SC) interferon β-1a. SC interferon -1b appeared to be associated with better out - Design/Methods: We queried the NARCOMS registry for comes. The effect was at least partially due to selection bias, 346 MS patients with ≥5 years of annual data who are cur - because the history of previous therapy switches in the short - rently treated with SC interferon β-1a (Rebif). The cohort was est treatment group suggested a more severe disease course. 77% women and 96% white, with average age 51.2 (stan - Further analyses are needed to assess the impact of lifelong dard deviation 9.0) years, disease duration 14.7 (7.8) years, treatment history and treatment failures on long-term out - and Patient-Determined Disease Step (PDDS) 3.6 (2.2). We comes, including employment. classified patients based on their most recent history on cur - Tuula Tyry, PhD*; Patricia Davis, MS; Timothy Vollmer, MD; Ruth Ann Marrie, rent treatment (<4, 4 to <5, and >5 years) and calculated MD, PHD; Gary Cutter, PHD; Denise Campagnolo, MD average PDDS, performance scale scores, relapse rate, and *Barrow Neurological Institute, Phoenix, AZ, USA employment rate as a function of disease duration for each (S88) Pain-Related Factors Associated With group. Results: PDDS increased with disease duration in all Complementary and Alternative Medicine Use groups; longer treatment duration was associated with lower in People With Multiple Sclerosis disability up to 15 years disease duration. Annual relapse rate was lowest (0.18–0.80) in the longest treatment group. Background: Complementary and alternative medicine As expected, age-adjusted employment rate was less than in (CAM) practices have been credited with reducing symptoms the general population and decreased with disease duration. and improving overall quality of life in people with multiple

International Journal of MS Care 38 Posters sclerosis (MS). However, few studies of MS have investigated mofetil. In March, September, and October 2007, the patient the relationship between CAM use and pain, a common and experienced severe exacerbations. Additionally, Sjogren’s often severe condition among this population. Objective: syndrome was diagnosed (laboratory studies, dry eye syn - Determine the prevalence of CAM use among a community drome) and symptomatic treatment initiated. This case repre - sample of people with MS, and examine its relationship with sents a diagnostic and therapeutic challenge in the context of pain-related variables. Methods: A mail survey was com - differentiation of MS versus NMO, especially because of pleted by 542 people with MS living in eastern Washington brain involvement and concomitant autoimmune disease. State. Data were collected on basic demographics, MS med - Classification of disease plus optimal treatment for the acute ical history, pain (items from the Numerical Pain Scale and relapses and long-term maintenance were considered. The Brief Pain Inventory), health care service utilization, and CAM patient is now regarded as a severe case of NMO with treatments in the preceding year. Results: Thirty-seven per - marked brain involvement. She takes an oral regimen of aza - cent of the sample had used at least one CAM modality in the thioprine/steroids and received four doses of rituximab. She preceding year, and the mean number of visits to a CAM is slowly recovering some but overall has significantly wors -

practitioner was 3.9 ± 12.3. The most commonly used thera - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 ened in her neurological and functional status. The case pies were chiropractics (18.1%), massage (14%), and the and relevant literature in this evolving area of NMO will be Swank diet (5.4%). Forty-nine percent of the sample reported having persistent, bothersome pain in the past 3 months. Use presented. of CAM therapies was not found to be associated with preva - Annette Wundes, MD*; Steven Hamilton, MD; Angeli Mayadev, MD; lence or intensity of pain. However, the mean number of days George Kraft, MD that pain interfered with usual activities in the preceding 3 *University of Washington, Seattle, WA, USA months was significantly lower for those receiving acupunc - Study supported by the National MS Society Greater Washington ture (mean 4.5 [standard deviation 7.2]) versus those not Chapter. receiving acupuncture (10.8 [24.2]; Student’s t test, P = .004) and for those receiving massage (5.9 [15]) versus those not (S90) T-Cell Subsets in Multiple Sclerosis Patients receiving massage ( 11.4 [25]; P = .009). Conclusions: Before and After Treatment With Natalizumab Individuals in this sample frequently used CAM services, with Blockade of lymphocyte trafficking into the central nervous more than a third using at least one modality in the preceding system (CNS) has been shown to be highly efficacious in year. The findings that both acupuncture and massage thera - treatment of relapsing forms of multiple sclerosis (MS). py use are related to decreased pain interference warrant fur - Because of safety concerns after two cases of progressive ther examination. Longitudinal studies of CAM use and pain multifocal leukoencephalopathy (PML) in patients receiving are needed. natalizumab and interferon, extraordinary vigilance on the Rohini Wadhwani; Dawn Ehde, PhD; George H. Kraft, MD part of the physician, manufacturer, and US Food and Drug University of Washington, Seattle, WA, USA Administration resulted in the TOUCH program. Education in Study supported by US Department of Education, National Institute on the use of clinical, magnetic resonance imaging, and cere - Disability and Rehabilitation Research, Grant #H133B031129. brospinal fluid data to detect the presence of PML is empha - sized, because early detection may be the key to effective (S89) Japanese Variant Multiple Sclerosis or treatment. A fall in CD4/CD8 T-cell ratios may predict risk of Neuromyelitis Optica? immune system compromise before infection. In patients who Background: Because our understanding of neuromyelitis received natalizumab, absolute and percentage CD4, optica (NMO)/Devic’s has improved, the diagnostic criteria absolute and percentage CD8, and CD4/CD8 ratios at base - have been recently revised. In the past, NMO was consid - line and before infusions at months 2, 3, 6, and 12 were col - ered a variant within the spectrum of multiple sclerosis (MS), lected. Data are presented in scatter-plot form to emphasize whereas now it is believed to be distinct from MS in terms of variations in individual patients. All data are means ± stan - pathology, prognosis, and treatment options. Previously, brain dard deviations at baseline ( n = 38) and before infusions at magnetic resonance imaging (MRI) abnormalities were months 2 ( n = 16), 3 ( n = 11), 6 ( n = 10), and 12 ( n = 11). incompatible with a diagnosis of NMO; the revised criteria Absolute CD4 was 0.994 ± 0.410, 1.253 ± 0.452, 1.087 ± no longer exclude per se abnormalities on brain MRI. The 0.270, 1.277 ± 0.353, and 1.312 ± 0.401 thou/µL. Per - controversy about whether Japanese variant MS is truly MS centage CD4 was 50.5 ± 11.5, 46.0± 10.7, 44.7 ± 9.6, or NMO remains unresolved. Methods: Presented is a case 47.7 ± 8.2, and 46.0 ± 9.7. Absolute CD8 was 0.409 ± presentation and literature review. Discussion: The patient is 0.241, 0.486 ± 0.173, 0.472 ± 0.237, 0.539 ± 0.152, a 33-year-old Japanese woman initially diagnosed with Japanese variant MS based on clinical course (optic neuritis and 0.539 ± 0.173. Percentage CD8 was 20.4 ±7.6, 18.0 ± February 2001, transverse myelitis April 2001), abnormali - 5.5, 19.0 ± 7.2, 20.5 ± 5.7, and 19.0 ± 5.6. CD4/CD8 ties on cervical and thoracic spine MRI, and cerebrospinal ratios were 2.73 ± 1.17, 2.70 ± 0.72, 2.60 ± 0.83, 2.46 ± fluid with pleocytosis but negative oligoclonal band and nor - 0.67, and 2.54 ± 0.67. Although no patients were diag - mal brain MRI. The patient had been clinically relatively sta - nosed with PML in this series, the use of CD4/CD8 ratios ble on interferon β-1a despite mild relapses and worsening of may be an effective means of early risk detection for oppor - her brain MRI with >40 new lesions atypical but not inconsis - tunistic infection. tent with MS. In September 2006, NMO-antibody testing Sylvia Lucas, MD, PhD was positive, and treatment was switched to mycophenolate University of Washington Medical Center, Seattle, WA, USA

International Journal of MS Care 39 Posters

(S91) Multiple Sclerosis and Neuropathic Pain uate the level of satisfaction with the support received in man - Rationale: Neuropathic pain is a chronic pain syndrome aging these symptoms. Results: One-fifth of the patients in known to occur in diseases such as multiple sclerosis (MS). this study reported pain in the top five areas of concern, mak - Hallmark clinical symptoms include numbness, burning, tin - ing pain the second-worst disease-induced symptom of MS. gling, and shooting pain. Currently, the diagnosis and med - Half of these patients were not receiving treatment for pain ical management of this chronic pain syndrome continues to management. In the remaining patients who were receiving challenge health care providers. Objectives: The general treatment, 50% reported that they were not satisfied with their objective was to determine the most commonly encountered current treatment regimen. Conclusion: Pain was the sec - disease-induced symptoms experienced by MS patients. The ond-worst disease-induced symptom of MS, behind fatigue. specific objectives included determining the incidence and The suboptimal medical management of neuropathic pain prevalence of MS patients suffering from neuropathic pain confirms the need for health care professionals to enhance and the overall satisfaction level of patients with the medical their education on the early recognition and current treatment management of this condition. Methods: A total of 1149 strategies targeted at MS-induced neuropathic pain. MS patients were asked to complete a baseline screening Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Christine Leong, BScPharm*; Amy Grossberndt, BScPharm; Meghann Klowak, assessment tool approved by the Health Research Ethics BScPharm; Joanne Major RN, MN; Lorissa Klassen, RN; Maria Melanson, MD; Board called the MS Quality of Life Inventory Initial and Fol - Dana Turcotte, BScPharm; Andrew Gomori, MD; Farid Esfahani, MD; Mike low-Up Questionnaire. The nature of the tool was to collect Namaka, PhD data of symptoms of concern associated with MS and to eval - *Multiple Sclerosis Clinic Health Sciences Centre, Winnipeg, MB, Canada

International Journal of MS Care 40 Works in Progress

care professionals, and links to the most current information Works in Progress on the National MS Society’s Web site . (W01) Living With Advanced Multiple Sclerosis: Kristine Beisel, BS Case Studies From One VA National MS Society, Denver, CO, USA The Veterans Healthcare System (VA) is able to offer various Study supported by Biogen Idec, Novartis, EMD Serono, and Genentech. services and levels of support unique to health care in the (W03) Withdrawn United States. This includes durable medical equipment, home-based health care, grants (in varying amounts) for (W04) Switching Disease-Modifying Therapies home adaptations, adapted vehicles, transportation to Because of Intolerable Injection Pain: appointments, home care, and nursing-home care. We pres - A Nursing Pilot Study ent the cases of two veterans with advanced multiple sclerosis (MS) who illustrate comprehensive VA care for different levels Background: Injection pain from subcutaneous administra - tion is often reported by patients receiving disease-modifying of eligibility. One veteran lives at home on respiratory sup - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 port, the other in a nursing home at VA expense. Further - therapies for multiple sclerosis (MS) and can contribute to more, these cases reveal important lessons critical to missed injections and therapy cessation. Injection and site advanced MS, including quality of life (who defines it, how to care strategies that nurses recommend to their patients are define it) and advanced illness planning (setting, end-of-life not always successful in managing this adverse reaction, and decision making). The stories of these two veterans illustrate consideration has to be given to an alternate therapy. Previ - amazing (and unexpected) resilience and adaptability in the ous studies have shown that patients experienced less pain β face of advancing disability and serve as inspirations to clini - when taking interferon 1-b (Betaseron) than with interferon β cians and caregivers, as well as to people with MS. 1-a (Rebif). Based on these data, we decided to evaluate injection pain after switching from interferon β1-a or glati - Elizabeth Auld, PA-C, MSCS ramer acetate (Copaxone) to interferon β1-b. Methods: VA Connecticut HCS, West Haven, CT, USA Patients reporting significant injection pain at their yearly fol - low-up appointment at the MS clinic were identified by their (W02) My Life, My MS, My Decisions: Personal neurologist or clinic nurse. Those who missed injections or Medical Decision Making for People altered their treatment schedule were offered the opportunity With Multiple Sclerosis to participate in the study. Patients completed a visual analog This course was created by the National Multiple Sclerosis scale rating injection-site pain of 3 consecutive injections of (MS) Society to help people with MS manage the personal their current therapy, followed by 3 consecutive injections of medical decisions they have to make. Karen DeJoe, DO; interferon β1-b. Pain was rated immediately after injection, George Garmany, MS; Loren Rolak, MD; and Jill Wright, after 10 minutes, and at 1 hour. Telephone consultation with MD, contributed content, and the course was written by sever - an MS nurse occurred after the 3rd and 6th injections. On al people, including Diane Schnieder, PhD. The series completion of the comparison trial, patients were allowed to includes four online courses and a DVD that can be used for choose which therapy they preferred. Results: Since March group education programs. This course series is directed to a 2007, six patients were identified and agreed to participate. β younger, often newly diagnosed, and tech-savvy audience Five patients were taking interferon 1-a, and one patient was taking glatiramer acetate. Less pain was recorded after with MS. These audience members typically access the taking interferon β1-b for all patients evaluated to date. Con - National MS Society’s Web site seeking answers to specific clusions: Interferon β1-b produced less injection pain than questions. By completing any of the courses within the My current subcutaneous therapy in six of our patients, all of Life, My MS, My Decisions series, audience members will feel whom decided to switch therapies to interferon β1-b. more empowered and confident in making decisions about Kathy Billesberger, RN, MSCN; Sharon Peters, RN, BN, MSCN; Colleen issues associated with MS. The course series will help to struc - Harris, NP, MSCN ture the decisions that people with MS might face once they University of Calgary, MS Clinic, Foothills Medical Centre, Calgary, AB, Canada have been diagnosed with MS by providing unbiased infor - Study supported by Bayer HealthCare Canada. mation and discussing information about the risks and bene - fits associated with their decisions. These courses will help (W05) Multiple Sclerosis Overlaid on Spinal Cord newly diagnosed people or those experiencing changes in Injury: Case Studies MS to reduce the anxiety associated with their decisions and Multiple sclerosis does occur in individuals with traumatic concerns and promote a sense of confidence and ownership spinal cord injury. The presence of a significant neuromuscu - over their decisions. Each course is ~30–60 minutes long and lar pathology complicates the process of diagnosis, and func - focuses on a specific topic. The titles for the courses within the tional impairments from spinal cord injury can have a signifi - My Life, My MS, My Decisions series are Teaming Up With cant effect on self-management strategies and rehabilitation Your Healthcare Team, Navigating the Medication Maze, goals with these complex patients. We discuss a series of Contemplating Clinical Trials, and Achieving Optimal Well - three case studies from a population of spinal cord–injured ness. The courses include decision-making tools (both quanti - veterans in the Veterans Affairs Health Care System to illus - tative and qualitative), checklists for discussions with health trate the complexities of diagnosis and treatment and the

International Journal of MS Care 41 Works in Progress functional implications of overlaying one significant neuro - resources accordingly to maximize the benefits of implement - muscular disease on another. ing this tool. Richard Buhrer, MN, ARNP Audrey Butterfield, MSSN*; Gale Stephens, MSSN VA Puget Sound Health Care System, Seattle, WA, USA *Calderdale and Huddersfield NHS Trust, St. Lukes Hospital, Huddersfield, West Yorkshire, UK (W06) Outcome Measurement for Outpatient Integrated Team Care for People With (W08) AIMS (Assessing Needs in Multiple Sclerosis) Project: Assessing Risk Factors for Multiple Sclerosis Poor Concordance Goal-attainment scaling is a technique developed in the Introduction: Concordance with medication is increasingly 1960s for monitoring achievement of goals for people in the being highlighted as an important aspect of treatment. The mental health system. It has subsequently been used as a tool World Health Organization has noted that “increasing the for outcome measurement in many other specialties. It offers effectiveness of adherence interventions may have a far special promise as a tool for measuring and quantifying goal

greater impact on the health of the population than any Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 achievement in rehabilitation teams. Because of the quantifi - improvement in specific medical treatments.” Patients with cation that the tool allows, efficacy, efficiency, outliers, and multiple sclerosis (MS) may need to take injectable therapy other aspects of team-implemented rehabilitation care can be long term. Physical, psychosocial, and cognitive issues can measured. Data are presented from ~5 years of using modi - influence their ability to do so. Concordance and measures fied goal-attainment scaling for outcome measurements in out - that improve concordance are therefore important. Objec - patient rehabilitation for people with spinal cord injury and tive: The objective of this study is to gain an understanding disease. Applicability to the care of people with multiple scle - of patient compliance with Rebif (interferon β-1a) therapy. rosis is discussed. Through collection of information from new and existing Richard Burer, MN, ARNP patients who are prescribed Rebif, we hope to identify risk VA Puget Sound Health Care System, Seattle, WA, USA categories for poor concordance that can be addressed through targeted interventions. Method: We have currently (W07) Multiple Sclerosis Competencies received written consent from 1155 patients across 55 cen - Collaborative Approach ters, and recruitment is ongoing. Data from these patients are collected at monthly intervals through scripted questions. Base Multiple sclerosis (MS) specialist nurses (MSSNs) were first data such as sex, age, and time on therapy are provided for appointed within the National Health Service (NHS) in 1992. all patients. New patients are asked about the quantity and Funding largely depended on a working partnership between quality of information received before treatment and their NHS, commercial, and charitable organizations. Although motivation and expectations before treatment. Existing the benefits of MS nurses were widely recognized, no formal patients are asked about their feelings about the treatment support or education package was available to facilitate pro - and why they might find taking treatment difficult. If patients fessional and service development. In April 2001, Specialist stop treatment, the reasons for stopping are also clarified. Nursing in MS–The Way Forward was launched in the House Results/Discussion: The number of patients who have pro - of Commons. This document provided guidance for the devel - vided sufficient data is currently too small to derive conclusive opment of MS specialist nursing posts and has become answers, but questions we will be looking at include: Do accepted as the key reference for developing MS specialist patients who are well informed take their treatment for longer nurse services in the United Kingdom. In July 2003, compe - and with less problems? From where do these patients receive tencies for MS nurses were launched to provide a valuable, their information? At what stage are patients most likely to guided learning tool to facilitate the individual and the post, stop and why? The results of this study may then be used to as well as promote the wider provision of MS services across develop appropriate interventions to improve concordance. the United Kingdom. In October 2004, the NHS Knowledge Janette Curlis, RN and Skills Framework (NHS KSF) was introduced to use in Newcastle upon Tyne Hospitals NHS Trust, Royal Victoria Infirmary, Newcastle development review. One of the main principles that NHS upon Tyne, Tyne and Wear, UK KSF has been based on is being able to use and link with the Study supported by Merck Serono UK. current and emerging competence framework. The aim of this project was to demonstrate the benefits and challenges we (W09) Networking of Multiple Sclerosis experienced when using the MS competency framework. In Tissue Banks our experience, the benefits provided a structured framework, Goal: Improve the availability, community awareness, quali - which facilitated clinical supervision, clinical governance, ty, and diversity of human tissue for multiple sclerosis (MS) driver for change, benchmarker, and evidence-based prac - research by networking different tissue banks. Background: tice. Although we recognized the challenges would be unique MS is strictly a human disease, and the animal model of the to each individual, we identified management support, disease is not ideal. As a result, having human brain and time/travel, identifying a clinical supervisor, and long-term spinal cord tissue available for MS research is critical. Typi - commitment to be individual to our experience. Nationally, a cally, MS tissue banks have been independently operated wide variation exists in how MS nurses deliver a service with - entities with different procedures for recruiting donors, in their organization, ie, center of excellence for MS, teach - processing and storing tissue, and providing tissue to ing hospitals, district generals, and primary care trusts. There - researchers. Collaboration of different tissue banks may be a fore, each area of practice would have to use available method to improve the MS tissue banking process.

International Journal of MS Care 42 Works in Progress

Methods: Since 2004, the Rocky Mountain MS Center This booklet is appropriate for patient and caregiver, commu - (RMMSC) and the Human Brain and Spinal Fluid Resource nity, and professional education. Center (HBSFRC) have worked collaboratively. This network Constance Easterling, MSN, ARNP, MSCN; Elisa Brown-Soltero, MD; Karla has now been expanded by the addition of a new tissue Ledoux-Coton, DO; Ivette Couret, MD; Seema Khurana, DO; Christine Ratliff bank at the University of Illinois at Chicago, the MS Reposito - MS Care Center of Neurological Services of Orlando, Orlando, FL, USA ry. This new bank, formed by Howard Lipton, MD, and Tibor Study supported by a Teva Neuroscience educational grant to the MS Valyi-Nagi, MD, PhD, brings the expertise of a well-known Foundation. MS investigator and an accomplished neuropathologist to the collaboration. Chicago is a large metropolitan area in a (W11) Development of Integrated Multiple region with a relatively high prevalence of MS. The MS Sclerosis Consortium Within St. Thomas Repository, RMMSC, and HBSFRC have dedicated profes - Health System sionals able to quickly and rigorously process donated and Background: St. Thomas Health Services (STHS) cares for requested tissue. Results: The processing methods of all multiple sclerosis (MS) patients in Middle Tennessee and in three banks are similar enough that samples from each bank portions of neighboring states. To facilitate care of this geo - Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 may be combined for large comprehensive studies. The com - graphically diverse MS population, and to optimize the use of bined resources provide neurological samples from >650 STHS resources, a systemwide approach to MS care delivery donors that can be used for MS research. More than 2800 was developed. Objective: Integrate independent neurolo - people have committed to donating their tissue to the three gists and hospitals into a unified MS care consortium within banks. Our work to increase public awareness of the tissue STHS. Methods: Four neurologists with specific interest in banks, in both the donor and investigative communities, is MS care were recruited from three independent practices also a collaborative effort. Conclusion: With the addition of within STHS. An MS patient population of 1500 patients was the MS Repository, we anticipate making great strides in the defined. A central MS patient database enabling temporal search for the causes and treatments of MS. documentation of the clinical, diagnostic, and therapeutic Kenneth Dole, MHS*; Rashed M. Nagra, PhD; Howard Lipton, MD; Tibor aspects of each patient’s care was developed and implement - Valyi-Nagy, MD, PhD; Matthew Corti, BS; Bette K. Kleinschmidt-Demasters, ed. MS specific physiotherapy and magnetic resonance MD; Patricia M. Kennedy, RN, CNP; Allen C. Bowling, MD, PhD imaging (MRI) services were developed. MS nursing special - *Rocky Mountain Multiple Sclerosis Center, Englewood, CO, USA ists were made available to provide needed nursing Study supported by National MS Society grants. resources locally . Results: After 1 year, member neurology practices were linked and able to share MS patient care (W10) Bridging the Gap Between Research, data. The centralization of MRI scanning enabled utilization Healthcare and You of conventional and nonconventional protocols optimized for Background: Research has shown that more women are MS imaging. MS nursing specialists provided site-directed developing multiple sclerosis (MS) than men. By 2000, the patient care not otherwise available at a local level. Conclu - ratio had grown to approximately 4:1. Meanwhile, women sion: An MS care consortium linking individual neurologists living with MS have special needs related to disease and and hospitals within STHS was implemented, enabling opti - symptom management, psychosocial adjustment, and sex- mal use of systemwide resources while optimizing and specific issues. Improved understanding of these issues can enhancing the services and care available to MS patients at empower women living with MS to take control of their dis - a local level. ease and gain hope for the future. Objective: Develop an Robert Fallis, MD*; Michael Kaminski, MD; John Witt, MD; Curtis educational tool describing the unique needs of women living Hagenau, MD with MS. The purpose of the booklet is to educate and *St Thomas Hospital, Nashville, TN, USA empower women with MS to effectively communicate with Study supported by St. Thomas Neuroscience Institute and Teva their health care providers, facilitating the highest standard of Neuroscience. care and optimal quality of life. Process: A team of medical professionals from diverse disciplines participated in an edu - (W12) Delivering Fatigue Self-Management cational program focusing on the needs and care of women Education by Teleconference with MS. Participating specialists included physicians from Background: Fatigue has been recognized as one of the neurology, gynecology/obstetrics, physical medicine, and most disabling symptoms of multiple sclerosis (MS). Use of rehabilitation and an advanced registered nurse practitioner energy conservation strategies is a self-management method certified in MS nursing. Each participant was assigned a spe - for combating this symptom. Objective: Describe a group- cific topic to present to the roundtable, which was followed based, teleconference-delivered fatigue management pro - by an open discussion on the perspectives of each discipline. gram that is currently being tested with a randomized control Topics included the diagnostic process, early treatment, trial design. Program History: The teleconference fatigue adherence and adjustment, symptom management, fertility, management program was developed in 2003 in response to pregnancy, sexual health, rehabilitation and exercise, and requests by individuals with MS. The program is a modifica - psychosocial and family issues. A summary of the presenta - tion of a program developed by Packer et al. and tested by tions and discussions was compiled for the lay reader for edu - Mathiowetz et al. Pilot testing of the teleconference version in cational purposes. Conclusions: This collaborative process 2003–2004 demonstrated significant potential, with partici - resulted in the development of an educational booklet titled, pants showing significant reductions in fatigue severity and Bridging the Gap Between Research, Healthcare and You . fatigue impact and improvements in self-efficacy and some

International Journal of MS Care 43 Works in Progress aspects of quality of life over the 6-week program. Program anticipated to represent a consistent point of reference and Development: Findings from the teleconference pilot study be used worldwide as a basis for developing evaluation and a qualitative follow-up study of participants and instruc - tools, quality assurance, orientation procedures, and perform - tors identified several strengths and limitations of the telecon - ance appraisal . ference program. Strengths included peer support, conven - Janet Francis, RN; Suzanne Stockdale, RN; Melissa Burton, RN ience, relevance of materials, and long-term utility of the MS Society NSW/Victoria, Box Hill South, Victoria, Australia partic ipant manual. Limitations included technical challenges, difficulty conveying some strategies by phone, and chal - (W14) Best Practice for Multiple Sclerosis Nurses lenges of accommodating the different needs and abilities of Managing Intramuscular Avonex (Interferon β-1a) group participants. With this knowledge, the teleconference In November 1996, the Australian Government approved a program was updated and refined. We describe these subsidy for the use of disease-modifying therapies (DMTs) in changes. For example, the participant manual has been the treatment of relapsing-remitting multiple sclerosis (MS). expanded, application activities have been refined, and The injectable immunomodulating medications available, in additional photographs have been included. To individualize order of approval in Australia, are Betaferon, Avonex, Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 the program, contact with the occupational therapist before Copaxone, and Rebif. Based on clinical experience along the progr am has been added as a component. Discussion/ with the results of clinical studies, early relapses have been Conclusion: The teleconference program is one example of confirmed to cause axonal damage and destruction of the how MS care teams can build on existing knowledge (tele - myelin. This has led to a consensus among neurologists to health, distance education, fatigue management) to develop support early initiation of therapy with an immunomodulatory and test new methods for delivering fatigue self-management medication in those diagnosed with relapsing-remitting MS. education to people with MS. Along with adherence to DMT, this has potential benefit in Marcia Finlayson, PhD, OTR/L, MSCS; Katharine Preissner, MHE, OTR/L reducing the number of relapses an individual may experi - University of Illinois at Chicago, Chicago, IL, USA ence. Guidelines are available for best practice in MS dis - Study supported by the National Institute of Disability and ease management. In our search for guidelines on best prac - Rehabilitation Research, Field-Initiated Research Program, tice for intramuscular (IM) therapy, current literature did not Grant #H133G070006. specifically relate to best practice in DMT. We decided to develop our own best-practice document in benchmarking our (W13) Best-Practice Approach for Immunotherapy own clinical practice, to best support people who have been Patient Support Program prescribed treatment with interferon β-1a and to optimize the Many complexities exist in providing a support program for individual’s adherence and thus the best outcome. The aim in patients starting intramuscular (IM) interferon β-1a (Avonex). developing this best-practice document was to provide a Of the disease-modifying therapies (DMTs) available, Avonex framework for immunotherapy nurses that will enhance the is sometimes perceived to be difficult to self-administer. As provision of comprehensive immunotherapy training educa - nurses, we asked ourselves what we could do to provide a tion specific to IM therapy and support for patients prescribed learning environment conducive to promoting self-manage - Avonex. The document is designed to complement Multiple ment of treatment with Avonex, understanding of the disease Sclerosis Best Practice Nursing Care, which is globally recog - process, patient adherence, and quality of life. Nurses nized. This presentation identifies the best-practice elements in involved in the delivery of Avonex may be experts within the the process of supporting a person with MS who has been β nursing discipline, but not all work within multiple sclerosis prescribed interferon -1a. (MS) health care teams, and they may be geographically iso - Janet Francis, RN; Suzanne Stockdale, RN; Melissa Burton, RN lated. With this in mind, a best-practice document was devel - MS Society NSW/Victoria, Box Hill South, Victoria, Australia oped to create a uniform approach for all nurses supporting and educating MS patients prescribed Avonex. As nurses (W15) Patient Education: Using Relaxation and involved in an Australia-wide support program for Avonex Guided Imagery to Lower Anxiety Associated With patients, we recognized a need to develop a framework for Multiple Sclerosis and Injections best practice. An extensive literature search identified abun - Background: Stress and anxiety, especially surrounding dant information on all DMTs and on best practice for MS disease-modifying therapies (DMTs), are major stumbling care; however, we were unable to locate any information blocks to adherence. Missed injections because of anxiety specific to best practice and immunotherapy. Best practice are frequent and a major factor in reduced efficacy. Guided encourages excellence, resulting in consistent standards of imagery (GI) techniques reduce anxiety that accompanies practice and quality support for patients. The best-practice chronic illnesses and painful medical procedures. Objec - framework identifies two components: 1) dimensions of tive: This study evaluated the efficacy of GI among relaps - immunotherapy: clinical practice and 2) dimensions of profes - ing-remitting multiple sclerosis (RRMS) patients who experi - sional practice. Section one is comprised of knowledge of the ence anxiety, including injection anxiety. Methodology: MS disease process and interventions, advocacy, assessment RRMS patients were taught GI at six sites after an initial of patient/treatment readiness, effective patient training and assessment of anxiety and diagnostic MS information. Relax - education, documentation, and multidisciplinary collabora - ation training preceded an MS-specific GI script aimed at tion and communication. Section two includes ethics, profes - lowering anxiety, injection anxiety, and the perception of sional development, and professional accountability. Our DMT as a healing ally. The scripted GI CD was given to document is written from an Australian perspective and is patients to practice daily for 2 weeks. The anonymous work -

International Journal of MS Care 44 Works in Progress shop evaluations were analyzed according to participants’ (W17) Application of Canadian Occupational ability to become deeply relaxed, experience reduction of Performance Measure for Sustaining Employment anxiety symptoms, and percieve GI as a helpful intervention. in People With Multiple Sclerosis Questionnaires were analyzed for perceived value of the A large body of evidence indicates that employment sustain - workshop, level of anxiety pre- and postworkshop, and partic - ability is a significant issue for people with multiple sclerosis ipant satisfaction with results. Also, patients indicated the (MS). Whereas many individuals with MS have a work histo - value of GI to lower anxiety and injection anxiety. Results: ry and are working at the time of diagnosis, most become Final results are presented. To date, 76% of participants unemployed in subsequent years. Although often the issue is returned workshop evaluations. Of those, 100% indicated maintaining employment, many people already off work want that they became deeply relaxed, 92% found GI to be a help - to return to work. Work issues are a frequent reason for refer - ful technique, and 75% reported lowered anxiety. Thirty-two percent returned the follow-up questionnaires. All reported a ral to our MS-specific interdisciplinary ambulatory rehabilita - lowering of anxiety. Of those, 55% specifically reported tion program, OPTIMUS. Work accommodations are fre - reduced injection anxiety, and 45% reported reduced gener - quently necessary for a person to return to or remain in a job. Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 al anxiety, as evidenced by improved sleep; confidence; Accommodations can be made to the environment, and self- reduced muscle tension, pain, and stress; and renewed ener - management strategies for MS symptoms can be implement - gy. Ninety-four percent found the workshop to be of value. ed. Within our program, the Canadian Occupational Per - Conclusion: GI was found to be effective in lowering gener - formance Measure (CMOP) is used as a framework to guide al anxiety and injection anxiety in most RRMS patients. our occupational therapy assessments and interventions, Miriam Franco, MSW, PsyD, MSCS*; Donald Barone, DO; Kathy Barone, RN; including those that address work or productivity. The model Fred Foley, PhD; Dorothea Cassidy Pfohl, RN, BS, MSCN; Jay Rosenberg, MD; focuses on the interaction of the person within the environ - Robin Tillett, RN, MSCN; Katherine Treadaway, LCSW ment to achieve the highest level of function in tasks meaning - *Immaculata University, Phoenixville, PA, USA ful to the person. The purpose of this presentation is to deter - Supported in part by the Multiple Sclerosis Association of America mine the proportion of patients with employment issues through a Bayer HealthCare Pharmaceuticals Educational Grant. referred to OPTIMUS in 2007, explain CMOP, and demon - strate its application to a case study. We show the various (W16) Development of Health Information File for components that need to be considered: the environment, the People With Multiple Sclerosis in United Kingdom occupation, and the person, which includes what is important Background: The National Service Framework for Long to him or her. This model is a comprehensive method for Term Conditions (DoH 2004) and Expert Patient Programme addressing the myriad concerns of people wanting to sustain (DoH 2004) highlight the need to improve the quality of care employment. for people with multiple sclerosis (MS) and to help develop Erin Gervais, BScOT(c); Jutta Hinrichs, BScOT, MSCS self-management of long-term conditions. People with MS are Calgary Health Region, Calgary, AB, Canada likely to encounter various health and social care profession - als, each of whom holds a separate record. For some (W18) Development of Newsletter for Multiple patients, this can lead to conflicting advice and interventions, Sclerosis Patients at Rehabilitation Center duplications, and certainly patient confusion. In addition, Communicating and educating patients can be a difficult task about half of all people with MS experience cognitive difficul - in an outpatient setting. Patients often have questions about ties, including impaired ability to learn, remember, plan, con - their disease and/or do not have the resources needed to centrate, and digest information quickly. The East Midlands know how to find the information they need. Historically, MS Specialist Nurse Group in England has developed a patients would call our facility and not know who to talk to or patient health information file to assist in involving the person how to reach the appropriate person. Funding was obtained with MS and caregiver more in their MS management plan. through a grant to explore these issues. A team of interdisci - Objective: The overall objectives of the health record/ plinary professionals consisting of a multiple sclerosis (MS) information file are to serve as an aid to structured and clinic nurse, MS research nurse, and MS case manager unstructured care; support effective communication through decided to develop a biannual newsletter that would be dis - education for patients, caregivers, and professionals; pro - tributed throughout our outpatient MS clinic and waiting mote patient-centered care through independent use of the rooms and mailed to our MS patients and area neurologists. health file; and facilitate the continuity of care. The health This publication includes education and information from information file was evaluated in pilot sites across the United many different areas: rehabilitation, speech therapy, medical Kingdom between January and March 2008. The results will director, research, nursing, case management, staff spotlight, be analyzed. patient profile, and psychology. The newsletter also includes Kathleen Franklin, Queen’s Nurse, MA, RN*; Rebecca Barraclough, RN; Fiona the most frequently called numbers for our MS clinic, a list of Cray, RN; Carolyn Derry, RN; Shannon Gaughan, MSc, RN; Debbie Quinn, RN; Debbie Wilkinson, RN MS resources, and a calendar of events. The grant originally *Northampton General Hospital Trust, Northampton, Northamptonshire, obtained to research patient needs was also used to fund this England, UK project. Study supported by a minor educational grant from Teva Marsha Hanson, RN, BSN, MSCN, CCRP; Emily Cade, MS, CRC, CCM Pharmaceticals Ltd. Shepherd Center, Atlanta, GA, USA

International Journal of MS Care 45 Works in Progress

(W19) Biomarkers of Therapeutic Response to gram will include a five-part educational series to heighten Interferon in Multiple Sclerosis: Understanding the independence of patients who are approaching young Individual Adverse Event Profiles in adulthood. The topics discussed in the series include current Interferon β–Treated Patients medical care, future adult health care, college and profession - al development, health insurability, and social and life skills. Background: We hypothesize that individual molecular Various educational methods will be used so that patients can response to interferon β (IFN β) injections determines the gain the full benefits of the program. The educational sessions nature of adverse events reported by patients. Rationale: will be conducted during “lunch and learn” sessions, during Although IFN β therapy is generally well tolerated, well- clinic visits, and on an individual basis. Program Evalua - described but poorly understood adverse events occur. These tion: After each of the five parts, at “graduation” from the include transient flulike symptoms, organ-specific toxicities, program, and 6 months afterward, patients and their par - and development of neutralizing antibodies. These adverse ents/guardians will be asked to provide feedback to evaluate events vary quantitatively and qualitatively among patients. the program’s effectiveness. Adverse events experienced by patients are assumed to be related to the molecular response to IFN β, but whether the Yolanda Harris, RN, MSN; Sarah Middleton, MPH; Jayne Ness, MD, PhD; Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Khurram Bashir, MD, MPH molecular response related to adverse events is distinct from UAB Center for Pediatric Onset Demyelinating Disease, Birmingham, AL, USA the molecular response related to therapeutic effects is unknown. Objective: Understand the individual adverse (W21) Dystel Nursing Fellowship Awarded to β event profiles in IFN -treated multiple sclerosis (MS) patients Pediatric Multiple Sclerosis Nurse in terms of the molecular response to IFN β injections. Design/Methods: We focus on review of a cohort of ~44 The John Dystel Nursing Fellowship in Multiple Sclerosis (MS) patients who have received weekly IFN β injections for 1 year. was originally established to provide comprehensive educa - We used methodology published by Mohr and colleagues to tion to nurses caring for adult patients diagnosed with MS. identify and quantify common adverse events associated with Thanks to a combination of improving magnetic resonance IFN β therapy. With a self-report methodology, patients were imaging techniques and greater awareness that MS can pres - asked to rate potential side effects on an 11-point Likert scale, ent in childhood, increasing numbers of children and adoles - ranging from 0 (no side effect at all) to 10 (worst effect imagi - cents aged <18 years are now being diagnosed with MS. nable). The patients completed the Medication Problems For the first time in the history of the establishment of the Dys - Questionnaire (MPQ) 2 or 3 days after their injections at tel Fellowship, an award was made to a nurse who special - baseline and 3, 6, and 12 months. Results: We review the izes in the care of pediatric MS patients. Because of the rarity results of a cohort of ~44 relapsing-remitting MS patient of pediatric MS, this extensive educational fellowship was responses to the MPQ and analyze trends. Conclusion/ unique. It was mentored by adult MS nurse specialists and Discussion: This project will lead to a better understanding incorporated education about the care of pediatric MS of the nature of IFN β adverse events and how they correlate patients seen in a multidisciplinary setting. This presentation to the individual molecular response to IFN β injections. will outline the educational experience and specialized train - Claire Hara-Cleaver, RN, MSN, CNP; Richard Rudick, MD; Jar-Chi Lee, MS ing that is useful for pediatric MS nursing, in addition to the Cleveland Clinic, Cleveland, OH, USA outreach experience that was achieved by formal involvement Study supported by the National MS Society and Biogen Idec. with the local chapter of the National MS Society. The 6- month training was intense, informative, and beneficial to the (W20) Program to Transition Pediatric Multiple start of a career as a leading nurse expert in the field of pedi - Sclerosis Patients to Adult Care and atric-onset MS. Independent Lifestyles Yolanda Harris, RN, MSN UAB Center for Pediatric Onset Demyelinating Disease, Birmingham, AL, USA Introduction: There is increasing awareness that multiple sclerosis (MS) can begin in adolescence or even in child - (W22) Working in Partnership: User-Led Day hood. Up to 5% of MS cases may begin before age 18 Service for People With Multiple Sclerosis in years. Between January 2006 and December 2007, 33 Norfolk, UK pediatric MS patients were evaluated by the University of Ala - bama at Birmingham’s Center for Pediatric-Onset Demyelinat - LAMS (Life & MS) is an independent day center that was set ing Disease (CPODD). The population was 64% female and up and is run by people with multiple sclerosis (MS) in North 55% black. Average age at onset of these pediatric MS Norfolk, East Anglia, UK. This followed the closure of a patients was 14.2 ± 0.5 years, with 87% ( n = 29) of the MS National Health Service (NHS) neurological day center that patients being >13 years of age at diagnosis. At the time of was hospital based. The closure resulted in people with MS the initial evaluation at CPODD, patients’ mean age was and their families feeling unsupported. The center currently 16.0 ± 0.5 years, an age when plans for college, career, offers group physiotherapy, aromatherapy massage, access and leaving their parents’ home are in the early stages of to the neurological specialist nurse, welfare advice, informa - development. The diagnosis and management of MS can be tion on MS and symptom management, arts and crafts, and a formidable barrier to making these life transitions success - social activities (quizzes, games, etc.). Two agency care - ful. Proposed Program: CPODD proposes to institute a givers are at the center. This means that anyone can attend structured program to assist patients and families not only to LAMS, however high their care needs, and ensures that transition to the adult health care environment but also in unpaid caregivers at home have at least 1 day off a week. adjustment to a more independent adult lifestyle. This pro - Transport to LAMS is available for a minimal cost. LAMS is

International Journal of MS Care 46 Works in Progress supported by the NHS Primary Care Trust, which provides the include the preferential lymphocyte-depleting therapy oral physiotherapy and specialist nurse, and Social Services, cladribine; lymphocyte-targeted therapies such as alemtuzum ab, which successfully applied for a Carers Grant that funds the rituximab, and ; agents that modulate immune- agency caregivers. LAMS is supported by the MS Society. It cell migration, such as and GSK683699; central has proved to be a valuable and cost-effective use of nervous system antigen modulators, such as MBP8298; and resources. LAMS has been running for 3 years and is self- agents that attempt to enhance immunoregulatory processes, supporting. Members pay a weekly subscription, which pro - such as and BG-12. These agents have the poten - motes ownership. An elected management team (all people tial for improved efficacy in the treatment of relapsing and with MS) makes decisions on running the center, and a progressive forms of MS. In addition, several agents in devel - buddy system operates when MS symptoms make it difficult opment will have oral formulations to facilitate administration. for these members to carry out their duties. I will share my The potential benefits of these new agents will be accompa - experience in helping to set up LAMS and the benefits this nied by new management challenges that nursing and other day center offers, not only to the service users but also to their health care professionals will have to address. They will need caregivers and everyone working with people with MS. to devote sufficient time to explaining these agents’ novel Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 Lynda Hind, Neurological Specialist Nurse mechanisms of action and risk/benefit ratios to patients. Kelling Hospital, Holt, Norfolk, UK Many agents in development will require new types of routine monitoring. For instance, cladribine will necessitate routine (W23) Prospering From Adversity: Understanding hematologic monitoring before the start of therapy and Benefit Finding in African Americans With before retreatment, as will alemtuzumab and rituximab. Mon - Multiple Sclerosis oclonal antibodies given by infusion are associated with infu - This pilot study examined cultural influences of benefit finding sion-related reactions that will need to be managed. Health for African Americans living with multiple sclerosis (MS). care professionals will need to be vigilant for new adverse Although African Americans are at a lower risk for develop - events that may occur in MS patients with some of these ing MS than white people, their disease progression tends to agents. For this reason, agents with a history of use in other be more aggressive. African Americans with MS are more disease states may give health care professionals a higher likely to have mobility impairments and symptoms affecting level of comfort. With the availability of these new agents, an the optic nerves and the spinal cord than whites. Several stud - interdisciplinary approach to MS therapy, involving services ies have measured benefit finding in people living with MS. by various health care professionals, will be needed. In a meta-analytic review of the relationship of benefit finding Diana M. Schneider, PhD with psychological and health outcomes, Helgeson, Reynolds, DiaMed, LLC/DiaMedica Publishing, New York, NY, USA and Tomich reported that minorities engage in benefit finding Study supported by EMD Serono, Inc. more than white individuals. However, no studies to date have focused exclusively on understanding benefit finding (W25) Withdrawn and the role of culture in African Americans living with MS. This study reports findings gathered during structured inter - (W26) Results of Group-Based Program to Manage views with African Americans who have lived with MS for ≥5 Fatigue in Multiple Sclerosis years and who report finding benefit from living with the disease. Interview questions assessed religiosity, positive Preliminary results of a pilot study on efficacy of Fatigue: Take reappraisal, enhanced interpersonal relationships, renewed Control! (FTC) for people with multiple sclerosis (MS) will be appreciation of life, and an altered sense of purpose. These presented. The National MS Society (NMSS) has produced factors were explored within the historical, familiar, and cul - FTC, a video-based group-therapy series based on the 1998 tural context of African Americans. Participants also complet - Fatigue and MS guidelines. It is intended to be a low-cost ed the Posttraumatic Growth Inventory, the Mental Health intervention to help people with MS make the behavioral Inventory, and the MS Quality of Life Inventory. Findings from changes necessary to manage fatigue. The program was this study will assist researchers and practitioners in better piloted in six NMSS chapters by the client services program understanding the cultural differences in benefit finding of in 2004, with 92–100% of responding participants endors - African Americans given the more debilitating course of MS ing positive changes in knowledge and behaviors at the end that they face. These findings have implications for future of the program and during a 3-month follow-up. Hundreds of research and will inform intervention development, programs, people have been exposed to the fatigue management pro - and policies targeted for African Americans with MS. gram at NMSS chapters across the United States. FTC now Vanessa Hodges, MSW, PhD; Crystal Yarborough, BA needs to be validated as an effective rehabilitation treatment, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA as recommended for all interventions. A randomized, con - trolled pilot study assessing the effectiveness of the NMSS (W24) New Disease-Modifying Therapies in video series is being conducted to provide necessary informa - Multiple Sclerosis: Implications for Management tion on effect sizes, outcomes, and initial effectiveness to vali - Increased understanding of multiple sclerosis (MS) pathophys - date this approach to treating fatigue. Results of the study to iology has resulted in the development of agents with new date will be presented. mechanisms of action. In the United States, 15 agents with Cinda Hugos, MS, PT novel mechanisms of action are now in phase 2/3 trials for Oregon Health Science Institute, Portland, OR, USA relapsing and progressive forms of MS. These new agents Study supported in part by a Pilot Research Award from NMSS.

International Journal of MS Care 47 Works in Progress

(W27) Quilting for Healing and Hope for cope with the effects of MS on the relationship, conflict resolu - Multiple Sclerosis tion skills, and increased marital satisfaction. The secondary Introduction: This is a story of a quilt, hope, and multiple objectives are to collect and analyze marriage satisfaction sclerosis (MS)—a patchwork of people, memories, and cre - data, create an effective marriage education approach that ative energy on a quest for a cure. Conjure up an image of a helps couples more effectively deal with challenges, provide quilt: layers of warm, soft, comforting fabric tucked around a model for marriage education to community-based organi - the body—a handmade expression of love. As described by zations who serve people with chronic illness and disability, fellow nurse Terri Pauser Wolf, there is a parallel with the and use information to enhance advocacy related to issues nursing profession with its essence in caring. Although the like domestic violence, the need for respite care, and others. project began as a personal awareness and fundraising Couples choose the educational format that best suits their effort, I was able to provide nursing care of support, educa - lifestyle and approach to learning, whether it is in person, tion, empowerment, and advocacy through it. Inspired by the online, on the phone, or all three. The program offers training AIDS and cancer memorial quilts, I envisioned a similar quilt topics such as financial planning, employment, keeping the Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 created by people with MS, their family members, friends, fun in your relationship, communication and conflict resolu - and health care professionals. Background: Historically, tion, intimacy, and parenting. Each couple receives individual quilts have been created by women and are recognized for attention from an MS Navigator to help with planning identi - their historical, artistic, and emotional value, as well as their fied learning goals and to act as a guide to all of the healing potential. Quilts are beautiful artworks that provide resources that are available to assist people with MS. The warmth and comfort and create a sense of unity among their Relationship Matters program is now in its second year of makers. Methods: With a grant to begin, I solicited home - funding. Our goal is to serve at least 2750 couples at the made quilt blocks. I provided fabric and simple instructions; end of the demonstration period. no sewing was necessary. I have created three quilts. Each Kimberly Koch; Lara Rezzarday, MPA quilt consists of 25 panels, each created by someone touched National MS Society, Denver, CO, USA by the disease who also donated money to the National MS Society or Multiple Sclerosis Foundation. Volunteer profession - (W29) Withdrawn al quilters assembled and quilted them. In addition to the (W30) Team Project: International Pilot Project on squares, panel contributors shared their stories and experi - Team Mentoring in Multiple Sclerosis ences, and this information travels along with the completed quilt. Results: Poignant themes reflected in the panels and The ongoing project is a pilot collaboration between the Ital - stories include endurance, faith, hope, humor, respect, admi - ian Multiple Sclerosis (MS) Society and the Consortium of MS ration, coping, a journey with chronic illness, and support of Centers (CMSC). The project, involving groups of health care family and friends. These quilts have been a valuable focal professionals from Italian MS clinics, provides a series of edu - point of display at public events, generating hope, inspira - cational courses and the opportunity to participate in a men - tion, and empathy for those living with this disease, the pub - toring program involving CMSC member centers. Experi - lic, and professionals. After display, the quilts are raffled as a ences will be shared with other MS clinic groups through fundraiser. Summary: This presentation will provide educa - regional seminars as the concluding phase of the project. The tion on the healing benefits of a quilt, offer suggestions for project’s global outcome is to improve the delivery of care to implementing this project in other communities, and display people with MS through promoting interdisciplinary collabo - one of the quilts. ration among health care professionals in MS clinics. General Michelle Keating, RN, OCN, MSCN team objectives include identifying ways health care profes - St. John’s Mercy Medical Center, St. Louis, MO, USA sionals can communicate more effectively, challenging cultur - al obstacles to interdisciplinary-based practice in MS, defin - (W28) Innovative Approach to Working With ing the unique and vital contribution of every team member, Couples: Relationship Matters When Multiple and critically examining current practice and organization to Sclerosis Moves In improve patient care. In addition, specific objectives were In 2006, the National Multiple Sclerosis (MS) Society was delineated for each discipline. The nurse’s goals are to define awarded a 5-year, $2.6 million demonstration grant to devel - and develop the role of the MS nurse within the interdiscipli - op and implement a project as part of the US Department of nary team and assess risks and benefits of taking an active Health and Human Services’ Healthy Marriage Initiative. role in assessment, care planning, and outcome assessment. General marriage education courses help couples deal with The psychologist’s goal is to define and develop the role of more common relationship challenges; however, when chron - the psychologist specialist in MS to better meet the needs of ic illness and disability are present in one partner, an addi - people affected by MS. The neurologist’s objectives include tional set of challenges enters the equation. This is why we evaluating the contribution that nonphysician health care pro - developed Relationship Matters: A Program for Couples Liv - fessionals make to comprehensive MS care, learning how ing With MS. The Relationship Matters program provides cus - shared decision making is applicable to interdisciplinary MS tomized relationship education designed to meet the unique teams and challenging cultural obstacles related to physician- needs of participating couples. The primary objectives of the headed hierarchies. A series of evaluation tools have been project include improved communication, increased skills to developed to provide ongoing monitoring of the project. The

International Journal of MS Care 48 Works in Progress results of the pilot project will be evaluated for applicability in the basis for instrument development. Selection was based on other countries. 1) literature review of major neurological conditions and Michele Messmer Uccelli, MA, MSCS*; Jennifer Boyd, RN, MHSc, CNN(C), HRQOL impact, 2) interviews with neurology experts, 3) a MSCN; Kathleen Costello, MS, CRNP; Marie Namey, RN, MSN, MSCN; Cindy consensus meeting with adult and pediatric neurology Phair, RN, MA, CMSN; June Halper, MSCN, ANP, FAAN experts, and 4) recommendations from the American *Italian MS Society, Genoa, Italy Acadamy of Neurology and consultation with our NINDS Study supported by Merck Serono Italy. officer. Step 2 of phase 1 involved identifying generic QOL scales relevant across conditions and targeted scales for each (W31) Serving Pediatric Clients and Their Families disease. Decisions were based on interviews with neurology at Alabama Chapter of National Multiple experts and focus groups and interviews with affected peo - Sclerosis Society ple. The final step of phase 1 was to develop item banks for generic domains and targeted scales. Results: MS is one of An estimated 2–5% of individuals with multiple sclerosis (MS) the five adult and two pediatric conditions that will serve as experience their first symptom before age 18 years. With an the basis for our project. The targeted scale recommended for estimated 400,000 people in North America with MS, Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 MS is fatigue/weakness. The 20 items for this scale were 8000–20,000 could be children and adolescents. In addi - selected from various sources. Conclusions: MS was identi - tion, a similar number of children seem to experience isolated fied as one of the top neurological conditions with an impact demyelinating events of the central nervous system such as on QOL. Generic banks and targeted scales for all conditions transverse myelitis (TM), optic neuritis (ON), and acute dis - will be tested in the second phase of this project, which seminated encephalomyelitis (ADEM). Whether TM, ON, or begins in spring 2008. ADEM is experienced as an isolated event or recurs, raising the possible diagnosis of MS, these complex disorders often Deborah Miller, PhD*; Cindy Nowinski, PhD; David Victorson, PhD; Amy Peterman, PhD have long-lasting effects that impact the long-term quality of *Cleveland Clinic, Cleveland, OH, USA life of children and adolescents. The National MS Society Study supported by National Institutes of Health/NINDS. (NMSS) has undertaken initiatives to serve the youngest indi - viduals living with MS or those suffering an isolated demyeli - (W33) Concordance With Disease-Modifying nating event by funding six Pediatric MS Centers of Excel - Therapy in Multiple Sclerosis lence across the United States. However, incorporating pediatric clients at the local chapters of NMSS, traditionally This poster presents the work undertaken by a group of multi - oriented toward adults, requires creative rethinking of how ple sclerosis (MS) specialist nurses (MSSNs) regarding con - services are delivered at the local level. The Alabama Chap - cordance of patients on disease-modifying therapy (DMT) in ter of NMSS has had a close relationship with the Southeast’s MS. The aim of DMT in MS is to reduce the frequency and Pediatric MS Center of Excellence, the University of Alabama severity of relapse rate by 30% over a 2-year period. Current - at Birmingham’s (UAB) Center for Pediatric-Onset Demyelinat - ly, all DMTs are administrated by injection, and patients need ing Disease (CPODD) since 2005, which has strengthened to adhere to the treatment regimen over the long term. Con - since funding began in 2006. This presentation will outline cordance is defined as a two-way partnership process that how this chapter has included pediatric clients, including respects the beliefs and wishes of the patient and as an attending the CPODD clinic, actively participating in CPODD agreement between the health practitioner and patient. educational events, providing financial assistance to families, Approximately 50% of patients with chronic medical condi - including information about pediatric MS in their outreach tions (eg, heart disease and hypertension) do not take their efforts, and piloting crossover events aimed at both youth and medications as prescribed. This means that patients are not adults. Future collaboration between CPODD and the Ala - getting the optimum benefit from their treatment, resulting in bama Chapter will involve completion of a needs assessment consequences for their health. In MS treatment, DMT compli - to identify which types of programs available at the local ance varies from region to region in the United Kingdom. chapter would be most useful to pediatric clients and their Reasons for poor compliance with DMTs for MS patients are families. misconceptions concerning the aim of treatment, perceived lack of efficacy of treatment, lack of information requiring Sarah Middleton, MPH*; Taylor Lander; Jayne Ness, MD, PhD treatment, injection-site reactions, and cognitive difficulties. *UAB Center for Pediatric-Onset Demyelinating Disease, Birmingham, AL, USA Ultimately, the decision whether to take DMTs lies with the patient. Health professionals and patients must engage in (W32) Neuro-QOl Project: Including Multiple shared decision making. The aims of the regionally held Sclerosis in Development of Clinically Relevant and workshops are to establish consistency throughout the process Useful HRQOL Measurement System and hence set a quality standard of practice, emphasize the Aims: Neuro-QOL is a National Institute for Neurological importance of partnership between MSSN and patients in Disease and Stroke (NINDS)–funded project. This 5-year deciding the most suitable option for DMT, and encourage study is designed to construct a clinically relevant and useful concordance with DMTs in the long term. The workshops are health-related quality-of-life (HRQOL) measurement system for practical and interactive, using different patient scenarios to major neurological conditions with item-response theory and encourage learning, and aim to develop MSSNs with a com - computer-adaptive testing. The two phases of this project are petency-based framework. instrument development and field testing/instrument refine - Kerry Mutch, RGN, BSc, MSCN; Alison Bradford; Nikki Embrey; Gail ment. We describe the inclusion of multiple sclerosis (MS) as Hayessharon; Letissier Del Thomas a targeted condition during phase 1. Methods: Step 1 of UK MSSNA, Fazakerley, Liverpool, England, UK phase 1 involved selecting neurological conditions to serve as Study supported by Merck Serono.

International Journal of MS Care 49 Works in Progress

(W34) Multiple Sclerosis Nurse Audit on used to create the model for an MS nursing-based outreach Qualitative Aspects of Care clinic. Conclusion: A needs assessment and proposal for an MS nursing outreach clinic will identify and guide nursing This presentation explores the contribution that nurses make to the quality of patient care from the patient perspective. In the service delivery to patients living in the outlying regions of the current political climate, debate regarding the cost and clini - Fraser Health Authority. cal effectiveness of specialist nurses is great because they Jill Nelson, RN, BScN, MSCN; Janene Spring, RN, BScN, MSCN; Galina Vorobeychik need to prove their service is a valuable resource. The pur - Fraser Health MS Clinic, Burnaby, BC, Canada pose of the audit is to identify the quality of care provided by multiple sclerosis (MS) specialist nurses, identify whether con - (W36) Screening and Treatment of Depression in tact with MS specialist nurses is beneficial, and identify which Multiple Sclerosis health care professionals people with MS would prefer to contact regarding an MS concern. Methods: Nine MS Purpose: Improve the effectiveness of depression treatment nurse specialists from different regions throughout the United in relapsing-remitting multiple sclerosis (RRMS). This study was Kingdom sent 150 questionnaires to their last patient con - presented as a concept poster at the 2007 Consortium of MS Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 tacts. The questionnaire comprised 11 statements with tick Centers conference. Interim data from the first year of the trial boxes to strongly agree/agree/disagree/strongly disagree, will be presented. Background/Significance: Depression with further space for patient comments. The statements is cited by the US Department of Health and Human Services included topics such as advice on symptoms, emotional sup - as one of the top 10 priority public health need areas in port, and access to service, direct contact, and management Healthy People 2010 , affects up to 50% of the RRMS popula - of condition. Results: Each center inserted its data onto an tion, and is associated with decreased immunotherapy treat - Excel database that was then centrally coordinated to collate ment adherence, increased disability, and decreased quality the results nationally. The presentation will identify current of life. Screening and access to care for depression is sub - findings and key points from the collated data. op timal, revealing a need for improved access to effective Kerry Mutch, RGN, BSc, MSCN; Alison Bradford; Nikki Ward; Del Thomas care. Method: This is a randomized 6-month pilot study Huseyin; Rhona Maclean; Sue Farmer; Kate Watkiss and, for ethical reasons, has a no-placebo design. As part of UK MSSNA, Fazakerley, Liverpool, England, UK standard care, patients at the MS Center at Dartmouth are Study supported by Serono. screened for depression with the Center for Epidemiologic Studies Depression Scale (CESD). RRMS patients with positive (W35) Developing Multiple Sclerosis Nursing CESD are offered participation and complete informed con - Outreach Clinic sent. Depression diagnosis is then confirmed via SCID-I. Sub - jects with a confirmed depressive disorder are randomized Background: The Fraser Health Authority is the largest and consecutively to one of two groups: 1) a nurse practitioner fastest-growing health region in British Columbia (BC), Cana - with dual specialization in neurology and psychiatry provid - da, serving a population base of 1.46 million in an area of ing depression treatment (medication, counseling, or combi - ~10,000 square kilometers (6200 square miles). Currently, nation treatment) or 2) referral to outside mental health practi - seven neurologists are addressing the needs of all neurologi - tioners (psychopharmacologist, psychotherapist, or both) as cal problems in this vast territory. The Fraser Health Multiple chosen by the subject. Both groups receive treatment for 6 Sclerosis (MS) Clinic was established in August 2004 to serve months. The primary endpoint is the Beck Depression Invento - the 3000 people living with MS in this region. Currently, we ry (BDI-II); secondary is the MS Quality of Life Inventory have >1000 patients registered in our clinic. The large geo - (MSQLI). Both are administered at baseline and study com - graphic area, coupled with the limited specialized resources, pletion. Results: This study is ongoing. Interim outcomes creates physical, financial, and/or geographic accessibility data will be presented for the first year of the study for BDI-II barriers for people living in this region. The nursing role in the and selected MSQLI variables. Preliminary trends suggest an Fraser Health MS Clinic includes symptom management, advantage in BDI-II reduction and improved MSQLI scores in patient and family education, disease-modifying therapy mon - the integrative care group. Implications: If preliminary itoring, acute relapse assessment/screen, and community results hold, the new care process model will demonstrate liaising. These functions are often performed independent of improved effectiveness of depression treatment in RRMS . the neurologist. The MS certified nurses can play a larger role Brant Oliver, NP, MSN, MPH, MSCN in the provision of care to MS patients in the community to DHMC–MS Center, Lebanon, NH, USA alleviate the effects of limited accessibility to specialized Study supported by a QRGP Grant Program, DHMC. resources. Goal: Perform a patient needs assessment, and develop an MS nursing outreach clinic model based on iden - (W37) Summer Camp Program for Children and tified needs. Method: A patient needs-assessment survey Teens With Multiple Sclerosis was mailed out to MS patients who attend our clinic. A com - Children and teens with multiple sclerosis (MS) need parison between the needs of patients living within a 10-km resources that relate to the particular concerns they face. It is radius of the Fraser Health MS Clinic and the needs of easy for this demographic group and their families to feel iso - patients living outside the 10-km radius was used to identify lated in the context of what is generally a disease of adults. the need for nursing service, location, nursing-specific servic - This presentation is an overview of the inaugural MS Society es required, and feasibility of community-based service of Canada camp specifically for kids with MS. The 3-day involvement. Results: Results of the needs assessment will be camp was the result of collaboration between the MS Society

International Journal of MS Care 50 Works in Progress of Canada, the Hospital for Sick Children’s Paediatric MS .001). Conclusion: After 3 months on natalizumab, patients Clinic, and the Easter Seal Society’s Camp Merrywood. The reported improvements in overall QOL, disease level, and goal of the camp was related to improved quality of life. The functional status. These outcomes were positively and signifi - program aimed to provide a fun experience for children with cantly associated with one another, suggesting that, in a real- MS, where they could escape the stressors of life with MS world setting, patients may begin experiencing improvement and meet others their age who had similar experiences, in a in disease progression and QOL as early as 3 months after safe and accessible environment. There was no formal pro - natalizumab initiation. gramming regarding MS. All travel and camp-related expens - Kitty Rajagopalan, PhD*; Judith Stephenson, SM; Siddhesh Kamat, MS es were covered. A total of 21 campers, aged 8–19 years, *Biogen Idec Pharmaceuticals, Cambridge, MA, USA came from all across Canada (3 from the United States) to Study supported by Biogen Idec Pharmaceuticals. the camp in Perth, Ontario. Two nurses from the pediatric MS clinic were onsite, as were four MS Society of Canada volun - (W39) Survey of Issues Related to Injection-Site teers. Campers always had a choice regarding which activi - Reactions Caused by Injectable FDA-Approved

ties to participate in, including water activities (kayaking, sail - Multiple Sclerosis Medications Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 ing, pool), arts and crafts (photography, pottery), drama Background: Although injection-site reactions are a well- (karaoke, hip hop classes), life skills (sushi workshop), and an known side effect of the US Food and Drug Administration overnight trip. The MS Society also organized a visit from a (FDA)-approved injectable medications, little is known about famous Canadian punk band musician who has MS. Post - the strategies being used to manage them or the relationships camp evaluations demonstrated the success of the program. among injection-site reactions and demographic variables, Although adjustments were made after the pilot program, the disease characteristics, and missed injections. Objective: only significant change based on camper and parent feed - Identify the characteristics of injection-site reactions as they back was that the MS Society of Canada camp for kids with are related to the use of the FDA-approved injectable multiple MS be extended to a full week in 2008. sclerosis (MS) medications (IMAs), including their characteris - Nadia Pestrak, MSc*; Jennifer Boyd, MHSc, RN, CNN(C), MSCN tics, associations with demographic and disease characteris - *MS Society of Canada, Toronto, ON, Canada tics, relationship to missed injections, and the most frequently Study supported by the RBC Foundation and an anonymous family used strategies for ameliorating these side effects. Design/ foundation. Methods: Using email, a registry (www.ms-cam.org), and a Web-based survey, we collected self-reported data related to (W38) Quality of Life, Disease Level, and injection-site reactions, IMAs, disease characteristics, and Functional Status Change Since demographics from 1381 people with MS. A subset of these Natalizumab Initiation data has been previously presented in a preliminary format. Objective: Assess the relationship between changes in The current analysis will further the previous analysis by patient-reported quality of life (QOL), disease level, and func - organizing the information in relation to the different IMAs tional status after 3 months on natalizumab (Tysabri). Meth - that were used by respondents. Results: We surveyed 1381 ods: Multiple sclerosis (MS) patients who received their third people with MS. Seventy-four percent were >40 years old, natalizumab infusion and were enrolled in the manufacturer’s 57% had at least a college degree, and 81% were nonsmok - restricted distribution (TOUCH) program participated in a 20- ers. Concerning IMA use, 87% of this group reported the fol - minute cross-sectional Internet or telephone survey. Outcome lowing: 28% interferon β-1a intramuscularly (Avonex), 13% measures included overall QOL change since initiating natal - interferon β-1b (Betaseron), 34% glatiramer acetate (Copax - izumab via a 3-point scale (1 = worse, 2 = no change, 3 = one), and 13% interferon β-1a subcutaneously (Rebif). Addi - better) and pre-/postdisease level and functional status tional analyses will include the frequency and severity of change. Disease level was measured on a 7-point scale (0 = injection-site symptoms in relation to the IMAs. Associations normal with no limitations on activity, 6 = wheelchair bound), will be presented between injection-site severity and demo - whereas functional status was measured on a 5-point scale graphic variables, including age, education, cigarette use, (1 = able to carry out usual daily activities, 5 = required ethnicity, sex, Hohol step, years since diagnosis, and time assistance). Paired and independent sample t tests were used using an IMA. The most frequently used strategies to manage based on the outcome metric. Results: Results from 319 injection-site reactions will also be presented. Conclusion: patients in this ongoing survey (expected n ≥ 400) indicated We will identify the characteristics associated with relatively that 75% were women. Overall QOL improved among 47% severe injection-site reactions and the most frequently used of patients, even in the short time on natalizumab. Only 3% strategies for managing them. of patients reported a worsening in QOL. On average, these Thomas Stewart, MS, PA-C*; Patricia Kennedy, CNP, RN, MSCN; Heidi Maloni, patients were diagnosed with MS 15 years ago, compared RN, CNP; Marjorie O’Leary, RN, CNP; Zung Vu Tran, PhD; Allen Bowling, MD, to the sample mean of 11 years. Increases in mean disease PhD; Kathryn Buckley level change scores (0.30 ± 1.13, P < .001) and functional *Rocky Mountain MS Center, Englewood, CO, USA status change scores (0.36 ± 0.80, P < .001) were reported, (W40) Clinical Considerations to Maximize Job indicating significant improvements. Compared with patients Retention for People With Multiple Sclerosis reporting no change or worsening QOL, patients reporting improved QOL had significantly higher mean disease change Goal: Provide practical guidance to clinicians to identify scores (0.56 ± 1.28 vs 0.08 ± 0.92, P < .001) and function - patients in the clinic at risk for changes in employment status, al status change scores (0.71 ± 0.82 vs 0.04 ± 0.63, P < and recommend interventions. Background: Employment

International Journal of MS Care 51 Works in Progress plays an important role in perceived quality of life for people therapy can be a useful tool in the rehabilitation process. Use with multiple sclerosis (MS), including maintenance of identity, of art as a creative modality can achieve impressive results physical and emotional health, financial security, and health when dealing with the multifaceted consequences of MS. care benefits. Changes in employment status can have a sig - Exploring traditional and nontraditional ways to enhance the nificant negative impact on the individual and family. Evalu - rehabilitation process and improve quality of life is important. ating Risk: Questions to evaluate risk with respect to Deborah Stutsman, ART-BC, LPC, BCPC*; Florian P. Thomas, MD, MA, PhD; changes in employment status will be presented, such as Rebecca Ballard, OTR inquiry about increased errors, longer work hours to accom - *AATA, St. Louis, MO, USA plish job tasks, increased perceived employment stress, nega - Study supported by a grant from the MS Foundation. tive feedback from employers, and probation or termination support. The importance of careful wording in medical docu - (W42) Silent Magnetic Resonance Imaging White mentation to protect patients who may seek to continue Matter Lesions in Patients With Clinically Isolated employment and support patients who may seek disability Syndrome Suggestive of Multiple Sclerosis insurance benefits will be described. Interventions: Collab - Clinically isolated syndrome (CIS) is a neurological event Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 orative interdisciplinary approaches will be recommended, caused by a single central nervous system (CNS) lesion that including neuropsychological evaluation; cognitive, physical, usually lasts >24 hours and resolves within weeks. Typically, occupational, and speech therapy; and interaction with reha - 30–70% of patients with CIS will develop definite multiple bilitation counseling and vocational service providers. sclerosis (MS). The most commonly affected areas are the Employment interventions related to use of compensatory optic nerves/cerebellum/brain stem (OCB) and spinal cord strategies, job modification and accommodation, and assis - (SC). Studies have demonstrated a direct relationship with the tive technologies will be described. Employment and dis - amount of lesions detected in magnetic resonance imaging abili ty-related resources will be provided. (MRI) and the risk for developing MS. We hypothesized that, Joe Stuckey, MS, CRC; Kurt Johnson, PhD besides obtaining images of the symptomatic area of the University of Washington Medical Center, Seattle, WA, USA CNS, nonaffected areas should be studied as well. Identify - Study supported by a grant from the US National Institute on Disability ing asymptomatic lesions will help us in the difficult decision and Rehabilitation Research (#H133B031129) to the University of of stratifying the risk for development of definite MS and in Washington. the consideration of treatment. Objective: Assess the fre - quency of asymptomatic cord lesions and brain lesions in (W41) Healing Power of Art Therapy for Multiple patients with OCB or SC CIS, respectively. Methods: This Sclerosis Patients retrospective study is in progress. We identified subjects that Background: In view of unpredictable exacerbations and presented to an MS clinic in Houston, TX, USA, with a diag - disease progression, patients with multiple sclerosis (MS) nosis of CIS. Results: We have identified 13 subjects out of often experience life as overwhelming. In this situation, the the 50 individuals we are expecting to enroll (84% women, benefits of art therapy can be significant. Creating art is a 16% men). Of these, 46% had an initial episode of optic neu - way to exercise control over one’s life rather than remaining ritis and 31% myelitis. Of the patients with an initial OCB powerless. Artistic expression can help manage stress and event (69%), 6 of 9 had clear abnormalities on brain MRI anxiety, increase confidence and self-esteem, and improve suggestive of demyelination. We found abnormalities in cord fine motor skills, eye-hand coordination, upper-extremity MRI in 4 of those. Of the patients with an initial SC event, all range of motion, and endurance. Working in groups and 4 had abnormalities in cervical MRI, and 2 had an abnormal sharing the process of making art can help develop interper - brain MRI. Conclusions: A trend to identify asymptomatic sonal skills and a sense of connection. Design: Art projects white matter lesions in other areas of the CNS was noted in were designed to emphasize participants’ strengths, intro - almost 50% of the patients with CIS. This finding will help duce them to multiple mediums, challenge their creativity, with the decision about which patients will be the best candi - emphasize enjoyment of the experience, and offer opportuni - dates for early therapy, thereby delaying definite MS. ties to verbally share their work and concerns with other par - Gustavo Suarez Zambrano, MD; Juan Ramirez, MD; George J. Hutton, MD; Victor M. Rivera, MD ticipants. Projects took them out of the patient perspective and Baylor College of Medicine, Houston, TX, USA encouraged self-empowerment, positive memories, and expe - riences. Several mediums were explored to accomplish our (W43) Strategies for Management of Multiple goals: clay, water color, collage, carving, and mosaics. Sclerosis Exacerbations Methods: Participants were 12 adults with MS. Instructors included one board-certified registered art therapist and The Multiple Sclerosis (MS) Society of New South Wales/ licensed professional counselor and one registered occupa - Victoria (NS W/VIC), Australia, encourages people with MS, tional therapist. The program included eight 2-hour weekly their families, and carers to develop a self-management sessions held at an easily accessible central location in the approach to living with MS. Strategies for self-management of community. Results: Participants reported that the experi - various chronic diseases have been extensively reported. In ence of creating art and the weekly contact with others this presentation, self-management will be defined within the helped them focus on the more positive and enjoyable context of professional practice with people with MS, with aspects of their lives, which helped relieve depression and particular focus on self-management of exacerbations. increased self-esteem regarding their creativity and ability to Although predicting when exacerbations may occur is diffi - interact with and support others with MS. Conclusions: Art cult, they are commonly experienced by people with MS.

International Journal of MS Care 52 Works in Progress

Given the high likelihood of an exacerbation, clients can be cles versus neuromuscular reeducation versus combination assisted to plan ahead for such an event. The potential and therapy for a 6-month period. demonstrated benefits of self-management will be discussed. Nina Tsakadze, MD; Stanley Krolczyk, DO, RPH; Lise Casady ARNP, MSCN Strategies that the MS Society of NSW/VIC has designed University of South Florida, Tampa, FL, USA specifically to assist its clients in coping with exacerbations Study supported by Myobloc-Solstice. will be described, with reference to the interdisciplinary process that has been used in developing and refining strate - (W46) Primary Care Psychology and Multiple gies. These strategies are conceptualized into three stages for Sclerosis: Integrated Treatment Approach optimal self-management of exacerbations: 1) building part - Background/Objective: Patients with multiple sclerosis nerships between people with MS and health professionals, (MS) are at increased risk for psychological conditions, starting with the initial psychosocial assessment and informa - including major depressive and bipolar disorders. Common tion sessions; 2) planning ahead, including tools that can be comorbidities include chronic pain, sexual dysfunction, and used by people with MS, their families, and carers; and 3) cognitive impairment. We explore the benefits of adding pri - reviewing needs and plans after exacerbations. Reference mary care psychology to the St. Louis VA Medical Center MS Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 will be made to a newly developed self-management tool, Center. Primary care psychology focuses on prevention and Your First Line of Attack, with an illustrative case study. treatment of psychological comorbidities to medical condi - Julia Taperell, BA, MSW tions by addressing psychosocial and behavioral factors relat - MS Society of NSW/VIC, Lidcombe, NSW, Australia ed to health and well-being. Design/Methods: The addi - Study supported by the MS Society of NSW/VIC, Australia. tion of a primary care psychologist, funded by an industry grant, to the multidisciplinary MS treatment team allows for (W44) Demoralization Syndrome in Patient’s With enhanced assessment and treatment of psychological comor - Multiple Sclerosis bidities within the “one-stop-shopping” model. Following the primary care model, veterans meet with the psychologist as a This presentation will discuss the importance of applying the part of their routine outpatient medical appointment or during concept of the demoralization syndrome to understanding the their routine inpatient care through the Spinal Cord Injury/ psychological functioning of patient’s with multiple sclerosis Dysfunction Service. The psychologist functions as another (MS). Historically, demoralization has been used to describe member of the treatment team, thus reducing possible stigma the psychological adjustment of patients with various chronic and avoiding the need to make separate appointments. and often severe medical conditions, including cancer and Rather than a traditional 1-hour therapy session, each veteran heart disease. It has only recently been cited as a psychoso - is seen for a 30-minute targeted assessment. Consistent with cial consequence of MS. Demoralization typically involves primary care psychology, the focus is on psychosocial and loss of meaning, feelings of hopelessness, a sense of incom - behavioral health issues related to MS, with an emphasis on petence, and existential distress. Although demoralization has brief, tailored, and solution-focused interventions. Results: commonalities with depression, demoralization should be Veterans’ chief complaints commonly include emotional distur - considered as a distinct clinical entity. Demoralization can be bances, relationship issues, and concerns over cognitive treated by addressing several existential issues with the MS impairment. Interventions most often relate to medication patient, including feelings of confusion, isolation, despair, adherence, cognitive compensation strategies, and cognitive helplessness, meaninglessness, and resentment. Various behavioral techniques aimed at improving emotional and scales have also been developed to objectively measure relationship functioning. Educational material about depres - demoralization. Future research directions for using the con - sion and sleep hygiene are provided. Based on the veteran’s cept of demoralization will be reviewed. needs, follow-up appointments or referrals to specialty servic - Richard Trezona, PhD es are made. Veterans appear to appreciate the increased attention to their emotional needs. Conclusion/Discus - Rehabilitation Institute of Chicago, Chicago, IL, USA sion: The addition of primary care psychology to an MS treatment team has facilitated more thorough medical care (W45) Botulinum Toxin Type B Versus for veterans. This is in keeping with the trend toward a multi - Neuromuscular Reeducation in Treatment of disciplinary approach to physical and behavioral health Chronic Back Pain in Patients With conditions. Multiple Sclerosis Sarah Wahl, PhD; Florian Thomas, MD, PhD; Frederic Metzger, PhD Multiple sclerosis (MS) is a chronic progressive neurological St. Louis VA Medical Center, St. Louis, MO, USA disorder with myriad pain syndromes. Chronic back pain is a Study supported by a Vandeventer Place Research Foundation commonly reported complaint of patients with MS. Many Biogen Grant. medications used for its treatment may interact with immunomodulating agents and thus may be detrimental to (W47) Model of Change to Improve Health patients’ health. Botulionum toxin type A has been reported in Maintenance in Patients With Multiple Sclerosis various nonrandomized, controlled trials to have some benefit Background: Patients with chronic neurological conditions in the treatment of back pain. Neuromuscular reeducation is requiring ongoing surveillance often receive most of their a natural way of using the autonomic nervous system path - health care in specialized practice settings. Frequent use of ways to help control spasticity and pain. We will compare the specialty services may compromise opportunities for age- use of botulinum toxin type B injections to the paraspinal mus - appropriate health promotion and disease prevention screen -

International Journal of MS Care 53 Works in Progress ing by primary care providers (PCPs). Nurse practitioners MS are transitions that demand attention to the biopsycho - responsible for the ongoing care of such patients may social needs of clients. Case management affords this atten - become primary resources for health promotion, disease pre - tion and collaboration necessary for a proactive approach, a vention, and PCP referral. Objective: Develop and imple - rapid response when needed, and positive outcomes. With ment a program to improve awareness and access to primary no cost to the client, the HouseCalls case management pro - care services for patients with multiple sclerosis (MS). Meth - gram of the MS Quality of Life Project (MSQLP) has proved ods/Design: Patients with MS were chosen because of the effective in assisting clients on the central coast of California need for preventive health care during the years MS is com - in meeting these needs. Over the past 3.5 years, MSQLP has monly diagnosed. The chronic-care model was chosen as the worked with 170 clients in completing >3000 goals and basis for this intervention. MS patients in a community neurol - objectives. We have supported our clients in addressing ogy practice will be sent materials outlining age- and sex- biopsychosocial needs that have become overwhelming and appropriate screening recommendations for cancer surveil - where the “hassle factor” is too great. lance (breast, cervical, prostate, colon), hypertension, Ame Wells, RN, MSCN*; Andrea Dowdall, MSW, Med

diabetes, hypercholesterolemia, and obesity and a structured *MSQLP, Teva Nurse Educator, IOMSN, CHOMP, Monterey, CA, USA Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 questionnaire regarding completion of recommended screen - Study supported by The California Endowment, Community Founda - ings within the previous 12 months. Questionnaire results will tion for Monterey County, The Harden Foundation, MS Foundation, be reviewed with patients at follow-up appointments and and The Monterey Peninsula Foundation. made available to corresponding PCPs. For those without a PCP, a local referral will be made. The frequency of complet - (W49) Resistance Training Enhances Muscle ed screenings will be measured and summarized to establish Strength and Mobility in Multiple Sclerosis baseline data. The questionnaire will be repeated at 1 year, Muscle weakness and fatigue are commonly reported symp - and results will be compared with baseline data to estimate toms that contribute to mobility impairment in people with the efficacy and impact of the program. Ongoing education multiple sclerosis (MS). Objective: Evaluate the effects of a will be provided to patients and caregivers via support- progressive resistance training program on muscle strength, group meetings, office handouts, and nurse practitioner inter - muscle endurance, and mobility in people with MS. Meth - action. Discussion: MS is a disabling condition, not a life- ods: Nine volunteers with MS (aged 50.4 ± 7.7 years, dis - threatening one. A health-promotion program for MS ability score 5.1 ± 0.7) completed a 16-week (3 days/week) patients with focused areas of care delivery fosters participa - progressive-resistance training program. Training consisted of tion and collaboration among patients, PCPs, and neurology three sets of 12–15 repetitions (70% of maximal strength for providers. This ultimately improves the well-being of people 1 repetition; 1RM) of upper- and lower-body exercises. Train - living with MS. ing load increased 3–5% when 15 reps were completed in Megan Weigel, MSN, ARNP-C, MSCN successive exercise sessions. Muscle strength (1RM), muscle Clay Neurology, Jacksonville, FL, USA endurance (chest press and leg press; number of reps to fatigue at 60% of 1RM), and mobility (25-ft and 100-ft walk (W48) Meeting Biopsychosocial Challenges of speed, 6-minute walk distance, and stair-climbing speed) Multiple Sclerosis Through Comprehensive were assessed before and after the training program. Case Management Results: Upper- and lower-body 1RM improved for all exer - Life challenges may seem unmanageable to the person with cises: shoulder press, 36%; chest press, 51%; lat pulldown, multiple sclerosis (MS); however, positive outcomes are possi - 43%; seated row, 31%; leg press, 70%; leg extension, 30%; ble with effective case management. Legal, financial, safety, and leg curl, 27% ( P < .05). Upper-body (chest press) and health, family dynamics, social support, and transitions in MS lower-body (leg press) muscle endurance improved by 163 are all dimensions of life challenges that can be addressed and 97%, respectively ( P < .05). Improvements were with case management. Navigating through the process of observed for 25-ft (20%) and 100-ft (17%) walking speed, becoming “deemed disabled” is daunting to many. Far too stair-climbing speed (20%), and 6-minute walking distance many people with MS experience unexpected insurance cov - (15%) ( P < .05). Conclusion: Resistance training may play erage changes and income adjustments. Completing forms an important role in attenuating muscle weakness, muscle and following procedures necessary for approval for low- fatigue, and functional losses associated with MS. income housing, Medicaid, caregiving support, medication Lesley White, PhD*; Sean McCoy, MS; Rebecca Larson, MS; Darpan Patel; benefits, etc., can challenge the perseverance of the hardiest Rebecca Crastnopol people, let alone someone with MS. Ensuring that the home *University of Georgia, Department of Kinesiology, Athens, GA, USA environment is safe, mobility needs are met, a caregiver is Study supported by the National MS Society. available, and monthly bills are paid can create anxiety. Sup - (W50) Poor-Prognosis Relapsing-Remitting Patient porting the overall health of the individual with MS can be Treated by Autologous Hematopoietic Stem-Cell intricate. Functional ability, medication management, mental Transplantation: 1-Year Follow-Up health, fatigue, cognition, and secondary health conditions require ongoing evaluation and care. Family dynamics can Background: High-dose immunosuppressive therapy create unpredictable levels of support, leading many patients and autologous hematopoietic stem-cell transplantation to become despondent. Insufficient social support systems (HDIT/AHSCT) may induce sustained remission in patients and the inability to communicate effectively lead to isolation. with autoimmune disease and is being tested as rescue thera - The unexpected exacerbation, relapse, and progression of py for multiple sclerosis (MS). In a previous clinical trial of

International Journal of MS Care 54 Whitaker Research Track

HDIT/AHSCT for advanced progressive-type MS (median and compared with data available from previous evaluations Expanded Disability Status Scale [EDSS] score 7.0), the esti - (median 442.5 days). Functional changes detected by VAS mated progression rate was 37% at 6 years. Because degen - and MSPhysical item scores were dichotomized (eg, worse or erative changes may contribute to loss of neurological func - no change/better). Results: Patient-perceived worsening tion in progressive MS, HDIT/AHSCT in relapsing-remitting was reported by 27.8% of patients via VAS. Worsening func - MS (RRMS) is currently being studied in a National Institutes tional status was detected in 14.4–31.1% of patients accord - of Health–sponsored clinical trial (HALT MS). Case Presen - ing to changes in MSPhysical item scores. Statistically signifi - tation: The case is a 27-year-old woman with RRMS for 8 cant correlations between VAS and the following MSPhysical years who continued to relapse on interferon β-1b, interferon item scores were observed: GETUP, r = 0.46, P < .05; β-1a, glatiramer acetate, methotrexate, and mitoxantrone. In STAIRS, r = 0.40, P < .05; STAND, r = 0.42, P < .05; FTG, the 12 months before enrollment, she had five relapses, and r = –0.23, P < .05; RLL, r = –0.44, P < .05; and LLL, r = as many as 24 enhancing lesions were seen on a single mag - –0.34, P < .05. χ2 analyses of independence demonstrated netic resonance imaging (MRI) scan. At baseline, EDSS was no statistically significant differences between VAS and any

5.5, and she had 13 enhancing lesions. The most recent fol - MSPhysical item score ( P > .05). Conclusion/Discussion: Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 low-up EDSS was 4.5. The patient is 1-year posttransplanta - Patient-perceived changes in ambulation detected by VAS tion now and has not experienced further relapses or progres - appear to reflect patient-reported functional status captured sion of disease nor developed new or enhancing MRI lesions. by the MSPhysical items of LIFEware. Although further vali - No unexpected or severe toxicity with HDIT/AHSCT was dation is warranted, incorporating complementary patient- experienced. Neutrophil and platelet counts recovered by oriented measures when attempting to define clinically mean - days 11 and 12, respectively. Discussion: This phase 2 ingful changes may provide valuable insight into the diverse study is being conducted in RRMS patients (EDSS 3.0–5.5 impact of MS. with ≥2 relapses on treatment and ≥1.0 EDSS worsening over Allison Drake, MS*; Barbara Teter, PhD, MPH; Bianca Weinstock-Guttman, past year) with HDIT/AHSCT with high-dose chemotherapy MD; Cornelia Mihai, MD; Paulette Niewczyk, MPH, PhD; Carl Granger, MD; (BEAM), antithymocyte globulin, and T-cell depletion of Robert Zivadinov, MD, PhD; Frederick Munschauer, MD hematopoietic cell grafts by CD34 selection. Twenty-five *Jacobs Neurological Institute, State University of New York at Buffalo, Buffalo, patients with an intended 5-year follow-up will be enrolled. To NY, USA date, five patients have enrolled in the trial. Conclusions: HALT MS is the first clinical trial of HDIT/AHSCT in RRMS Investigation of Patients With Multiple Sclerosis patients poorly responsive to conventional treatment. Thus far, That Improve Over 5 Years patients have tolerated the treatment well, and early results This study used the LIFEware System MSPhysical measure, suggest some neurological improvement, as illustrated by this which is a composite of patient-reported outcomes of disabili - 1-year follow-up of the first transplanted patient. ty and limitations, and the Expanded Disability Status Scale Annette Wundes, MD*; George Kraft, MD; James Bowen, MD; Harry (EDSS) to assess functional change longitudinally in patients Openshaw, MD; Stephen Forman, MD; Elliot Frohman, MD; Linda Griffith, MD; with multiple sclerosis (MS). Data were obtained from the George Hutton, MD; Paolo Muraro, MD; Uday Popat, MD; Michael Racke, Jacobs Neurological Institute, the largest site within the New MD; Peter Sayre, MD; Olaf Stuve, MD; Richard Nash, MD York State MS Consortium. A total of 751 patients were *University of Washington, Seattle, WA, USA assessed at enrollment and 5-year follow-up. The study objec - tives were twofold: investigate what proportion of patients Whitaker Research Track improved over a 5-year period versus staying the same or worsening, and determine which factors were associated with Validation of Ambulation-Specific Visual Analog an improvement in function over time. Patients were classified Scale With LIFEware System into three groups (improved, stayed the same, or worsened) Background: When defining a clinically meaningful based on differences between baseline and 5-year follow-up change in ambulation in multiple sclerosis (MS), consideration scores. All groups were equal in terms of EDSS and MSPhysi - of the patient’s perspective is crucial. Subjective visual analog cal rating at baseline. Overall, 7% of patients improved in scales (VASs) represent potentially promising complements to functioning, 23% remained the same, and 70% worsened objective clinical measures. The LIFEware System has been over a 5-year period. No significant difference was found in widely embraced as a valid, reliable, patient-oriented meas - patient age, age at MS onset, age at MS diagnosis, duration ure of functional status. Objective: Validate VAS as a meas - of MS, education level, marital status, family history, sex, or ure of patient-perceived change in ambulation with the race in patients who improved compared with those who MSPhysical component of LIFEware. Design/Methods: stayed the same or worsened. Patients classified as having Data from 90 MS patients (mean age 47.8 ± 10.5 years; relapsing-remitting MS were significantly more likely to have mean Expanded Disability Status Scale score 2.9 ± 1.7) were improved at 5-year follow-up, and patients classified as sec - studied. Patients reported change in ambulation by marking a ondary progressive were significantly more likely to have horizontal 10-cm line anchored by word descriptors (eg, worsened at 5-year follow-up ( χ2 = 57.04, df = 8, P < .01). much worse ). On a scale of 0–100, VAS scores ≤25 were Patients who were employed were significantly more likely to arbitrarily selected to represent meaningful worsening. have stayed the same or improved at 5-year follow-up than Patient-perceived problems rising from a low seat (GETUP), those not employed ( χ2 = 17.98, df = 6, P < .01). In conclu - stair climbing (STAIRS), standing (STAND), fatigability (FTG), sion, a small percentage of patients improved over a 5-year and using right (RLL) and left (LLL) lower limbs were assessed period with two measures, the MSPhysical and EDSS.

International Journal of MS Care 55 Whitaker Research Track

Employment at baseline through 5 years was associated with IL-12p70 or IL-23 confers encephalogenicity. Adoptive trans - patients who improved. fer of IL-12p70 or IL-23 polarized cells into naive syngeneic Paulette Niewczyk, PhD, MPH; Carl V. Granger, MD; Bianca Weinstock- hosts resulted in an ascending paralysis that was clinically Guttman, MD; Barbara Teter, PhD, MPH; Cornelia Mihai, MD; Robert indistinguishable between the groups. However, histological Zivadinov, MD, PhD; Frederick Munschauer, MD and reverse transcription polymerase chain reaction University at Buffalo, Amherst, NY, USA analysis of central nervous system (CNS) tissues revealed distinct histopathological features and immune profiles. Effect of Exhaustive Exercise on Cognitive Function Although IL-12p70–driven disease was characterized by in Individuals With Multiple Sclerosis macrophage-rich infiltrates and prominent NOS2 upregula - Background: Approximately 54–65% of individuals with tion, neutrophils and granulocyte colony-stimulating factor (CSF) were prominent in IL-23–driven lesions. The monocyte- multiple sclerosis (MS) experience cognitive impairment at attracting chemokines CXCL9, 10, and 11 were prefer- some point during their disease course. Until recently, only entially expressed in the CNS of mice injected with individuals with significant disease progression were thought IL-12p70–modulated effectors, whereas the neutrophil- Downloaded from http://meridian.allenpress.com/ijmsc/article-pdf/10/S1/i/2090882/1537-2073-10_s1_i.pdf by guest on 23 September 2021 to experience cognitive impairment; however, sufficient evi - attracting chemokines CXCL1 and CXCL2 were upregulated dence now shows that cognitive impairment can occur in the CNS of mice given IL-23–modulated effectors. Treat - among individuals with mild MS. Numerous researchers have ment with anti-IL-17 or anti–granulocyte-macrophage CSF suggested that global fatigue may affect cognition. Research inhibited EAE induced by transfer of IL-23–polarized but not has demonstrated that among healthy individuals, an acute IL-12p70–polarized, cells. These findings indicate that autoim - bout of exercise improves cognitive functioning. Purpose: munity can be mediated by distinct effector populations that This study examined cognitive functioning before and after a use disparate immunological pathways to achieve a similar maximal exercise test in people with mild MS to determine clinical outcome. whether fatigue resulting from acute exercise would adversely Mark A. Kroenke; Thaddeus J. Carlson; Anuska V. Andjelkovic; Benjamin M. affect cognitive functioning. Methods: The sample was 25 Segal, MD women with relapsing-remitting MS (mean Expanded Disabili - University of Michigan, Ann Arbor, MI, USA ty Status Scale score 2.5) and 15 matched healthy control Study supported by National MS Society grant RG3866-A-3 and subjects. Participants completed computerized versions of the National Institutes of Health grant NS047687-01A1. Erikson’s Flanker Task and Stroop Color Word Task immedi - ately before and after a maximal exercise test on a cycle Identification of Novel Soluble TREM-2 Protein ergometer. Results: Repeated-measures analyses of variance in Cerebrospinal Fluid and Its Association With revealed no group differences in reaction time or accuracy on Multiple Sclerosis and Central Nervous the Flanker and Stroop tasks. A significant time main effect System Inflammation for reaction-time responses indicated faster reaction time after Triggering receptor expressed on myeloid cells 2 (TREM-2) is the exhaustive bout of exercise. t tests showed that individuals a membrane-bound receptor expressed on some myeloid with MS had improved reaction time on both cognitive tasks cells, including microglia and macrophages. Engagement of (range of d 0.62–1.02), and these findings were consistent TREM-2 on these cells has been reported to reduce inflamma - with the control subjects (range of d 0.75–1.32). Conclu - tory responses and, in microglial cells, to promote phagocyto - sion: Among this sample of mildly impaired individuals with sis. TREM-2 function is critical within the central nervous sys - MS, exhaustive exercise had no deleterious effect on reaction tem (CNS) because its genetic deficiency in humans leads to time or response accuracy during cognitive tasks. Moreover, neurodegeneration with myelin and axonal loss. Blockade of exhaustive exercise was associated with significant improve - TREM-2 was shown to worsen the mouse model for multiple ments in reaction time for both the Flanker and Stroop tests. sclerosis (MS). In the current study, a soluble form of TREM-2 This initial research finding suggests that vigorous exercise protein (sTREM-2) has been identified. sTREM-2 was detected may be beneficial for cognitive functioning. Exercise might be in human cerebrospinal fluid (CSF), and was significantly ele - an instrumental means for maintaining and improving cogni - vated in subjects with MS and other inflammatory neurologic tive function among individuals with mild MS. diseases compared with subjects with noninflammatory neuro - Erin M. Snook*; Ruchika Shaurya Prakash; Arthur F. Kramer; Robert W. Motl logic diseases. In contrast, levels of sTREM-2 in the blood did *Department of Kinesiology and Community Health, University of Illinois at not differ among the groups. Furthermore, TREM-2 receptor Urbana-Champaign, Urbana, IL, USA expression was demonstrated on a subset of CSF monocytes and was also highly expressed on myelin-laden macrophages Interleukin-12 and -23 Induce Distinct Types of in the CNS tissue in active demyelinating MS lesions. Elevat - Experimental Autoimmune Encephalomyelitis ed levels of sTREM-2 might inhibit the anti-inflammatory func - The interleukin (IL)-12 p40 family of cytokines (composed of tion of the membrane-bound receptor in MS. Therefore, IL-12p70 and IL-23) plays a critical role in the development of sTREM-2 is a possible target for future therapies. experimental autoimmune encephalomyelitis (EAE). However, Laura M. Piccio*; Cecilia Buonsanti; Marina Cella; Ilaria Tassi; Robert E. Schmidt; John Rinker II; Paola Panina-Bordignon; Chiara Fenoglio; Daniela the relative contributions of IL-12 and IL-23 to the pathogenic Galimberti; Elio Scarpini; Marco Colonna; Anne H. Cross process remain to be elucidated. We show that activation of *Department of Neurology and Neurosurgery, Washington University School of uncommitted myelin-reactive T cells in the presence of either Medicine, St. Louis, MO, USA

International Journal of MS Care 56 CMSC_ad_FINAL:Layout 1 5/15/08 1:47 PM Page 1

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