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• W1566703402 abstract "OBJECTIVE:To present demographic and baseline disease characteristics of patients in the OPERA I and II studies.BACKGROUND:Ocrelizumab (OCR) is a recombinant humanized monoclonal antibody that selectively targets CD20+ B-cells. Two Phase III trials, OPERA I and II, are investigating the efficacy and safety of OCR compared with INFβ in patients with relapsing MS (RMS).DESIGN/METHODS:The OPERA trials are randomized, double-blinded, double-dummy, parallel-group studies investigating the efficacy and safety of 600 mg OCR administered by intravenous infusion every 24 weeks compared with high-dose, high-frequency IFNβ1a (44 µg 3x per week). Patients were randomized (1:1) to OCR or IFNβ. Entry criteria included a diagnosis of RMS (McDonald criteria, 2010), Expanded Disability Status Scale (EDSS) score of 0-5.5, and age of 18-55 years. At least 2 documented relapses within the last 2 years or one relapse in the last one year prior to screening were required. The primary endpoint is the annualized relapse rate at 2 years.RESULTS:A total of 821 and 835 patients were randomized in OPERA I and II, respectively. Mean baseline age was 37.0 and 37.3 years, respectively in OPERA I and II; 66.0[percnt] of patients were female. Patients had symptoms of MS for a mean duration of 6.5 years in OPERA I and 6.7 years in OPERA II. The mean EDSS score was 2.80 in OPERA I and 2.82 in OPERA II. The mean number of gadolinium enhancing (Gd+) lesions on brain MRI was 1.79, with 59.7[percnt] of patients with no Gd+ lesions in OPERA I, and 1.87 and 59.8[percnt] respectively in OPERA II.CONCLUSIONS:The OPERA I and II baseline data are consistent with a RMS population. The results of the OPERA studies will provide information on the efficacy and safety of ocrelizumab compared with IFNβ in RMS.Study Supported by:F.Hoffmann-La Roche Disclosure: Dr. Hauser has received personal compensation for activities with BioMarin and Receptos as a scientific advisory board member. Dr. Comi has received personal compensation for activities with Teva, Novartis, Genzyme, Merck Serono, Biogen Idec, Bayer, Actelion Pharmaceuticals, Almirall, and Serono. Dr. Hartung has holds stock and/or stock options from Opexa Therapeutics. Acorda Therapeutics, Inc.; Biogen Idec; Novartis Pharmaceuticals Corp; Teva Neuroscience, Inc.; Genzyme; Sanofi; Celgene; NIH; NMSS Dr. Selmaj has received personal compensation for activities with Genzyme Corporation, Novartis, Ono Pharmaceutical, Roche Diagnostics Corporation, Synthon, Teva Neuroscience, and Biogen Idec. as a consultant and/or speaker. Dr. Traboulsee has received personal compensation for activities with Roche Diagnostics Corporation, EMD Serono, Teva Neuroscience, and Biogen Idec, Novartis, and Genzyme Corporation. Dr. Bar-Or has received research support from Amplimmune, EMD Serono, and Novartis. Dr. Arnold has received personal compensation for activities with Acorda, Bayer Healthcare, Biogen Idec, Merck Serono, Genentech, Genzyme, GlaxoSmithKline, Medimmune, Novartis, Receptos, Inc., Roche, Sanofi-Aventis, and Teva. Dr. Klingelschmitt has received personal compensation for activities with F. Hoffmann-La Roche as an employee. Dr. Leppert has received personal compensation for activities with Roche Diagnostics Corp. as an employee. Dr. Kakarieka has received personal compensation for activities with F. Hoffmann-La Roche as an employee. Dr. Garren has received personal compensation for activities with F. Hoffmann-La Roche as an employee. Dr. Kappos has received personal compensation for activities with Actelion Pharmaceuticals." @default.
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• W1566703402 date "2015-04-06" @default.
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• W1566703402 title "Baseline Demographics and Disease Characteristics from OPERA I and II, Two Phase III Trials Evaluating Ocrelizumab in Patients with Relapsing Multiple Sclerosis (P7.201)" @default.
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