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Ectrims Meeting November 2015

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Ectrims Meeting November 2015 SUPPLEMENT TO HIGHLIGHTS FROM THE ECTRIMS MEETING NOVEMBER 2015 Ocrelizumab May Reduce Disability Progression in People With Primary Progressive MS Data support the hypothesis that B cells are central to the underlying biology of MS. BARCELONA—In people with primary progressive Overall, the incidence of adverse events associated multiple sclerosis (MS), treatment with ocrelizumab may with ocrelizumab was similar to that of placebo. The most significantly reduce the progression of clinical disability common adverse events were mild-to-moderate infusion- sustained for at least 12 weeks, compared with placebo, related reactions. The incidence of serious adverse events according to results from a pivotal phase III study presented associated with ocrelizumab, including serious infections, at the 31st Congress of the European Committee for Treat- was also similar to that of placebo. ment and Research in Multiple Sclerosis (ECTRIMS). In the “People with the primary progressive form of MS typi- study, which is called ORATORIO, clinical disability was cally experience symptoms that continuously worsen after measured by the Expanded Disability Status Scale (EDSS). the onset of their disease, and there are no approved treat- Ocrelizumab is an investigational, humanized mono- ments for this debilitating condition,” said Sandra Horn- clonal antibody designed to selectively target CD20-posi- ing, MD, Chief Medical Officer and Head of Global Product tive B cells. CD20-positive B cells are a type of immune cell Development for Genentech, the developer of the therapy. thought to be a key contributor to myelin damage and axo- “Ocrelizumab is the first investigational medicine to show nal damage. Preclinical studies suggest that ocrelizumab a clinically meaningful and statistically significant effect on binds to CD20 cell-surface proteins expressed on certain B the progression of disease in primary progressive MS.” cells, but not on stem cells or plasma cells, thus potentially In addition to ORATORIO, the phase III clinical devel- preserving important functions of the immune system. opment program for ocrelizumab includes OPERA I and The ORATORIO trial was a randomized, double- OPERA II, which are randomized, double-blind, double- blind, global multicenter study. Researchers adminis- dummy, global multicenter studies in people with relapsing tered placebo or 600 mg of ocrelizumab by IV infusion forms of MS. The results of the studies appear to validate the every six months to 732 people with primary progressive hypothesis that B cells are central to the underlying biol- MS. The doses of ocrelizumab were given as two 300-mg ogy of MS. Genentech plans to pursue marketing autho- infusions two weeks apart. The primary end point of the rization for ocrelizumab in relapsing MS and in primary study was time to onset of confirmed disability progres- progressive MS. The company will submit data from the sion, defined as an increase in EDSS that is sustained for OPERA I and II studies and from the ORATORIO study to at least 12 weeks. the FDA in early 2016. n Supplement to Neurology Reviews® | November 2015 S1 TECFIDERA is one pill, twice a day.1 Indication Four weeks after stopping TECFIDERA, mean lymphocyte Tecfidera® (dimethyl fumarate) is indicated for the counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had treatment of patients with relapsing forms of multiple 9 sclerosis. lymphocyte counts <0.5x10 /L. TECFIDERA has not been studied in patients with pre-existing low Important Safety Information lymphocyte counts. TECFIDERA is contraindicated in patients with known There was no increased incidence of serious infections hypersensitivity to dimethyl fumarate or any of the observed in patients with lymphocyte counts <0.8x109/L excipients of TECFIDERA. TECFIDERA can cause or 0.5x109/L in controlled trials, although one patient in anaphylaxis and angioedema after the first dose or at any an extension study developed PML in the setting of time during treatment. Patients experiencing signs and prolonged lymphopenia (lymphocyte counts predominantly symptoms of anaphylaxis and angioedema (which have <0.5x109/L for 3.5 years). In controlled and uncontrolled included difficulty breathing, urticaria, and swelling of the clinical trials, 2% of patients experienced lymphocyte throat and tongue) should discontinue TECFIDERA and counts <0.5x109/L for at least six months. In these patients, seek immediate medical care. the majority of lymphocyte counts remained <0.5x109/L A fatal case of progressive multifocal leukoencephalopathy with continued therapy. A complete blood count including (PML) occurred in a patient who received TECFIDERA. PML lymphocyte count should be obtained before initiating is an opportunistic viral infection of the brain caused by the treatment, after 6 months, every 6 to 12 months thereafter JC virus (JCV) that typically only occurs in patients who are and as clinically indicated. Consider treatment interruption immunocompromised, and that usually leads to death or if lymphocyte counts <0.5x109/L persist for more than six severe disability. The symptoms associated with PML are months and follow lymphocyte counts until lymphopenia is diverse, progress over days to weeks, and include resolved. Consider withholding treatment in patients with progressive weakness on one side of the body or serious infections until resolved. Decisions about whether clumsiness of limbs, disturbance of vision, and changes in or not to restart TECFIDERA should be based on clinical thinking, memory, and orientation leading to confusion and circumstances. personality changes. At the first sign or symptom TECFIDERA may cause flushing (e.g. warmth, redness, suggestive of PML, withhold TECFIDERA and perform an itching, and/or burning sensation). 40% of patients taking appropriate diagnostic evaluation. TECFIDERA reported flushing which was mostly mild to TECFIDERA may decrease lymphocyte counts; in clinical moderate in severity. Three percent of patients trials there was a mean decrease of ~30% in lymphocyte discontinued TECFIDERA for flushing and <1% had serious counts during the first year which then remained stable. flushing events that led to hospitalization. Taking 02-13388_R02_TEUS_2Pg_JA_Pt_Cmpn Upd_A.indd 1 10/22/15 1:34 PM With TECFIDERA, half as many patients relapsed in the 2-year DEFINE* trial† PROPORTION OF PATIENTS RELAPSED‡ PLACEBO 46% 50 40 % 49 1,2 RELATIVE RISK REDUCTION 30 P<0.0001 20 TECFIDERA 27% Proportion of Patients Relapsed of Patients Proportion 10 n=408 n=410 0 BL 12 24 36 48 60 72 84 96 Time on Study (Weeks) TECFIDERA with food may reduce flushing. Alternatively, For additional important safety information, please see administration of non-enteric coated aspirin prior to adjacent Brief Summary of full Prescribing Information. dosing may reduce the incidence or severity of flushing. * Determination of the Efficacy and Safety of Oral Fumarate in TECFIDERA may cause gastrointestinal (GI) events Relapsing-Remitting MS, a 2-year, randomized, double-blind, (e.g., nausea, vomiting, diarrhea, abdominal pain, and placebo-controlled study in 1234 patients with relapsing-remitting multiple sclerosis (RRMS).1,2 dyspepsia). Four percent of TECFIDERA patients and † <1% placebo patients discontinued due to GI events. Included patients who had experienced at least 1 relapse over the year preceding the trial or had a brain magnetic resonance The incidence of serious GI events was 1%. The most imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing common adverse reactions associated with TECFIDERA (Gd+) lesion within 6 weeks of randomization and had an Expanded versus placebo are flushing (40% vs 6%) and GI events: Disability Status Scale (EDSS) score ranging from 0 to 5.1 abdominal pain (18% vs 10%), diarrhea (14% vs 11%), ‡ Relapses were defined as new or recurrent neurologic nausea (12% vs 9%). Elevations in hepatic transaminases symptoms not associated with fever or infection that lasted have been reported. for at least 24 hours and were accompanied by new objective neurologic findings.2 A transient increase in mean eosinophil counts was seen §Based on number of prescriptions from IMS NPA™ Weekly Data during the first two months. TECFIDERA should be used (September 27, 2013 to July 3, 2015). during pregnancy only if the potential benefit justifies the References: 1. TECFIDERA Prescribing Information, Biogen, potential risk to the fetus. Encourage patients who Cambridge, MA. 2. Gold R, Kappos L, Arnold DL, et al. N Engl J Med. become pregnant while taking TECFIDERA to enroll in the 2012;367:1098-1107. Erratum in: N Engl J Med. 2012;367:2362. TECFIDERA pregnancy registry by calling 1-866-810-1462 3. Biogen, Data on file. or visiting www.TECFIDERApregnancyregistry.com. For more information, visit TECFIDERAHCP.COM 170K 5+ YEARS TECFIDERA has been OF CLINICAL AND TECFIDERA is contraindicated in PATIENTS prescribed in the US more than patients with known allergy to 1,3 TREATED GLOBALLY3 any other oral therapy for RMS§ dimethyl fumarate1 © 2015 Biogen. All rights reserved. 10/15 TEC-US-0808 02-13388_R02_TEUS_2Pg_JA_Pt_Cmpn Upd_A.indd 2 10/22/15 1:34 PM Tecfidera® (dimethyl fumarate) delayed-release capsules, placebo patients experienced lymphocyte counts <0.5x109/L (lower 9 for oral use limit of normal 0.91x10 /L). The incidence of infections (60% vs Brief Summary of Full Prescribing Information 58%) and serious infections (2% vs 2%) was similar in patients treated with TECFIDERA or placebo, respectively. There was no 1 INDICATIONS AND USAGE increased incidence of serious infections observed in patients TECFIDERA is indicated for the treatment of patients with relapsing with lymphocyte counts <0.8x109/L or 0.5x109/L in controlled trials, forms of multiple sclerosis. although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly 2 DOSAGE AND ADMINISTRATION <0.5x109/L for 3.5 years) [see Warnings and Precautions (5.2)]. In 2.1 Dosing Information controlled and uncontrolled clinical trials, 2% of patients experienced The starting dose for TECFIDERA is 120 mg twice a day orally. After lymphocyte counts <0.5x109/L for at least six months.
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