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Factors Influencing the Patient Evaluation of Injection Experience with the Smartject® Autoinjector in Rheumatoid Arthritis H

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Factors Influencing the Patient Evaluation of Injection Experience with the Smartject® Autoinjector in Rheumatoid Arthritis H Factors influencing the patient evaluation of injection experience with the SmartJect® autoinjector in rheumatoid arthritis H. Schulze-Koops1, R. Giacomelli2, W. Samborski3, S. Rednic4, M. Herold5, R. Yao6, M. Govoni7, N. Vastesaeger8, H.H. Weng6 1Division of Rheumatology, Department of Internal Medicine IV, University of Munich, Munich, Germany; 2University of L’Aquila, L’Aquila, Italy; 3Ortopedyczno-Rehabilitacyjny Szpital Kliniczny, Poznań, Wielkopolskie, Poland; 4University of Medicine and Pharmacy, Cluj-Napoca, Romania; 5Medical University of Innsbruck, Innsbruck, Austria; 6Merck & Co., Inc., Whitehouse Station, NJ, USA; 7MSD Italy, Rome, Italy; 8MSD Belgium, Brussels, Belgium. Abstract Objective To evaluate factors influencing injection patterns and patient evaluations of an autoinjector device in biologic-naïve patients beginning golimumab (GLM) treatment. Methods GO-MORE was an open-label, multinational, prospective study in patients with active rheumatoid arthritis (RA) (28-joint disease activity score based on erythrocyte sedimentation rate [DAS28-ESR] ≥3.2). Patients injected 50 mg subcutaneous GLM once monthly for 6 months. Patients reported use preferences and autoinjector evaluations by questionnaire. Responses were analysed descriptively. Effects of patient variables were evaluated with chi-square tests or t-tests. Results Of 3,280 efficacy-evaluable patients, 67.7% self-injected with the autoinjector. Compared with patients who self-injected, patients who had someone else administer injections had greater baseline disease activity (e.g. DAS28-ESR 5.84 vs. 6.23, respectively), but not more tender/swollen joints in hands/wrists. Month 6 efficacy was greater for patients who self-injected. In those who self-injected, injection site (thigh [75.2%; 1,563/2,077], abdomen [17.4%; 363/2,077], upper arm [7.2%; 151/2,077]) was not associated with wrist swelling or tender/swollen joints in the hand used for injection. Autoinjector ratings were similar across injection sites, yet less pain/discomfort was associated with abdomen injection. Patient autoinjector ratings were favourable overall (e.g. ease of use, pain). Patients with baseline functional impairment had slightly less favourable ratings. Conclusion Biologic-naïve patients who self-injected had less baseline disease activity and higher response rates than patients who did not self-inject. Although patients prefer to inject in the thigh, injection in the belly may be less painful. Most patients who self-injected had favourable autoinjector evaluations; patients with functional impairment had slightly less favourable ratings. Key words rheumatoid arthritis, golimumab, biologic products, tumour necrosis factor-alpha Clinical and Experimental Rheumatology 2015; 33: 201-208. Use of the SmartJect® autoinjector in patients with RA / H. Schulze-Koops et al. Hendrik Schulze-Koops, MD, PhD Introduction may still be reluctant to use them either Roberto Giacomelli, MD, PhD Previous studies have shown that treat- because of physical limitations, lack of Wlodzimierz Samborski, MD, PhD ment administration route plays a key confidence, or other factors. This may Simona Rednic, MD, PhD role in the treatment choices for patients particularly be the case for patients Manfred Herold, MD, PhD, Ass. Prof. Ruji Yao, PhD with rheumatoid arthritis (RA) and that with RA who are just beginning treat- Marinella Govoni, PhD patients generally prefer to receive ment with biologics because they gen- Nathan Vastesaeger, MD treatment at home and as infrequently erally have high disease activity and Haoling H. Weng, MD, MHS as possible (1–3). However, individual are not familiar with the autoinjector Please address correspondence to: patients may differ in their preferences device. The current study evaluated the Prof. Dr. Hendrik Schulze-Koops, for route of administration, self-injec- use of an autoinjector device for sub- Division of Rheumatology, tion versus injection by another person, cutaneous (SC) injection of golimumab Med. Klinik and Poliklinik IV, and injection locations. In a study of (GLM) in patients being treated for 6 Ludwig-Maximilians University Munich, preferences among patients with RA months in the GO-MORE study, a Pettenkoferstraße 8a, 80539 Munich, Germany. for self-injection of tumour necrosis large, multinational study of patients E-mail: factor (TNF) alpha inhibitors, approxi- with RA who were naïve to biologic [email protected]. mately half of patients reported that treatment. The goals of this subanaly- de they preferred to self-administer their sis were: Received on July 14, 2014; accepted in treatment. Younger patients were more 1. to explore baseline characteristics of revised form on December 1, 2014. likely to prefer self-administration than patients who chose to self-inject versus © Copyright CLINICAL AND older patients, and younger patients those who had someone else perform EXPERIMENTAL RHEUMATOLOGY 2015. reported greater confidence in their their injections; ability to self-administer (3). About a 2. to compare the efficacy of GLM in third of patients, however, reported that patients who did versus those who did they prefer to receive their treatment in not self-inject; a clinical setting. This subgroup cited 3. to look at the relationships among the opportunities for social interaction autoinjector use preferences; patient and the availability of staff in case of evaluations of the autoinjector; and complications as their main reasons for patient characteristics, including age, this choice (3). overall disease activity, disease activity A variable that may influence ability in the hands and wrists, and functional or desire to self-administer RA medi- impairment. cations is that administering injections may be difficult or painful if patients Methods have inflammation and/or joint damage Study design in the hands and fingers. Functional The GO-MORE study was an open- impairment of the hands may make it label, multinational, multicentre pro- more difficult for RA patients to self- spective trial (ClinicalTrials.gov iden- inject, and injection may be more dif- tifier: NCT00975130) composed of ficult in certain body locations because 2 parts. Only results from Part 1 are of the functionality in the hands that is reported here. The study received ap- required. Such difficulties with injec- proval from appropriate Research Eth- Funding: this study was supported by a tion, or concerns regarding these is- ics Committees and was conducted in grant from Schering-Plough (presently sues, could affect dosing consistency accordance with the Declaration of Merck & Co., Inc., Whitehouse Station, or overall patient compliance, either of Helsinki and standards of good clini- NJ, USA). which could decrease treatment effec- cal research practice. After a screening Competing interests: H. Schulze-Koops tiveness. To help give patients the best phase of approximately 7 days, pa- has received consultancy and speaking fees, and honoraria from MSD, AbbVie, instruction on how to use injection de- tients received 50 mg SC GLM by the ® Roche, Pfizer, and UCB. vices, it would be helpful to have more SmartJect autoinjection device (Jans- R. Yao is an employee of Merck & Co., information about patient characteris- sen Biotech, Inc., Horsham, PA) once Inc., Whitehouse Station, NJ, USA. tics and/or disease characteristics asso- monthly for 6 months. Patients con- M. Govoni is an employee of MSD Italy, ciated with difficulty or ease of use of tinued their current disease-modifying Rome, Italy. injection devices, such as disease activ- anti-rheumatic drug (DMARD) regi- N. Vastesaeger is an employee of MSD ity in the hands, level of overall func- men. Patients were given the option Belgium, Brussels, Belgium. H.H. Weng is a former employee of Merck tional impairment, age, and gender. to self-inject, have their injections ad- & Co., Inc., Whitehouse Station, NJ, USA. Autoinjection devices are designed to ministered by a properly trained care- The other co-authors have declared no alleviate some of the difficulties of in- giver, or have injections administered competing interests. jection with syringes, but some patients in the clinic. 202 Use of the SmartJect® autoinjector in patients with RA / H. Schulze-Koops et al. Patients 1 or more post-baseline visits. No for- previously (4). The efficacy-evaluable Patients had active RA despite mal statistical hypotheses were planned population consisted of 3,280 patients. DMARD therapy and were biologic- for this open-label study; however, the naïve. The main inclusion criteria were sample size in GO-MORE was planned Dosing frequency a diagnosis of RA according to the 1987 for an 85% probability of detecting dif- Of patients who received 6 total dos- revised American College of Rheuma- ferences of at least 10% in the propor- es of SC GLM (n=3,025), the aver- tology (ACR) criteria, active disease tion of patients achieving DAS28-ESR age dosing interval was <29 days for (28-joint disease activity score based EULAR response at 6 months among 6.88% of patients; 29 to 31 days for on the erythrocyte sedimentation rate patient subgroups using an overall 79.8% of patients; and >31 days for [DAS28-ESR] ≥3.2) despite DMARD 2-sided alpha of 0.05 and controlling 13.32% of patients. In response to the treatment, and use of at least 1 DMARD for multiplicity. autoinjector questionnaire item asking at a stable dose for at least 1 month prior To evaluate adherence to recommended whether patients were satisfied with to entering the study. Details
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