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Ocrelizumab No Evidence of Disease Activity (NEDA) Status at 96 Weeks in Patients with Relapsing Multiple Sclerosis: Analysis of the Phase III Double-Blind, Double-Dummy, Interferon beta-1a-Controlled OPERA I and OPERA II Studies (PL02.004)

2016; Lippincott Williams & Wilkins; Volume: 86; Issue: 16_supplement Linguagem: Inglês

10.1212/wnl.86.16_supplement.pl02.004

1526-632X

Anthony Traboulsee, Douglas L. Arnold, Amit Bar‐Or, Giancarlo Comi, Hans‐Peter Hartung, Ludwig Kappos, Fred Lublin, Krzysztof Selmaj, Gaëlle Klingelschmitt, Donna Masterman, Paulo Fontoura, Peter Chin, Hideki Garren, Stephen L. Hauser,

Mycobacterium research and diagnosis

Objective: To evaluate the effect of ocrelizumab vs interferon beta-1a (IFNβ-1a) on achieving no evidence of disease activity (NEDA) in patients with relapsing MS over 96 weeks in two identical Phase III, randomized, double-blind, double-dummy trials (OPERA I and OPERA II). Background: MS treatment goals are evolving with the emergence of higher-efficacy therapies. NEDA is a composite measure of the absence of clinical and MRI findings and a rapidly emerging treatment goal. Methods: In OPERA I and OPERA II, patients were randomized (1:1) to receive ocrelizumab 600mg via intravenous infusion every 24 weeks or subcutaneous IFNβ-1a 44μg three-times weekly over 96 weeks. NEDA (defined as no relapses, confirmed disability progression [CDP], new/enlarging T2 lesions, or gadolinium-enhancing T1 lesions) was analyzed over 96 weeks. MRI was assessed at baseline, 24, 48, and 96 weeks. Results: At 96 weeks, 47.9[percnt] and 47.5[percnt] of ocrelizumab-treated patients vs 29.2[percnt] and 25.1[percnt] of IFNβ-1a-treated patients achieved NEDA in OPERA I (64[percnt] increase; p<0.0001) and OPERA II (89[percnt] increase; p<0.001), respectively: 80.4[percnt] and 78.9[percnt] of ocrelizumab-treated patients vs 66.7[percnt] and 64.5[percnt] of IFNβ-1a-treated were without relapses; 92.4[percnt] and 89.4[percnt] of ocrelizumab-treated patients vs 87.8[percnt] and 84.9[percnt] of IFNβ-1a-treated were without CDP; 91.7[percnt] and 90.2[percnt] of ocrelizumab-treated patients vs 69.8[percnt] and 63.9[percnt] of IFNβ-1a-treated were without gadolinium-enhancing T1 lesions; and 61.7[percnt] and 60.9[percnt] of ocrelizumab-treated patients vs 38.7[percnt] and 38.0[percnt] of IFNβ-1a-treated were without new/enlarging T2 lesions in OPERA I and OPERA II, respectively. After week 24, ≥96.0[percnt] of all ocrelizumab-treated patients compared with 60.8-70.9[percnt] of IFNβ1-a-treated patients were without new/enlarging T2 lesions. Conclusions: Ocrelizumab consistently resulted in greater achievement of NEDA vs IFNβ-1a over 96 weeks, with elimination of new/enlarging T2 lesions in nearly all patients after week 24. Supported by F. Hoffmann-La Roche Disclosure: Dr. Traboulsee has received personal compensation for activities with Genzyme and Roche. Dr. Traboulsee has received research support from Genzyme, Roche, Chugai. Dr. Arnold holds stock and/or stock options in NeuroRx Research, which sponsored research in which Dr. Arnold was an investigator. Dr. Bar-Or has received personal compensation for activities with Bayer, Bayhill Therapeutics, Berlex, Biogen Idec, BioMS, Diogenix, Eli Lilly as a consultant, speaker and advisory board member. Dr. Comi has received personal compensation for activities with Teva, Novartis, Genzyme, Merck Serono, Biogen, Bayer, Actelion, Almirall, and Serono Symposia International Foundation. Dr. Hartung has received personal compensation for activities with from Bayer, Biogen, GeNeuro, Genzyme as speaker, committee member, consultant. Dr. Kappos9s institution (University Hospital Basel) has received royalty payments from Neurostatus Systems GmbH. Dr. Lublin has received personal compensation for activities with Acorda Therapeutics, Inc., Biogen Idec, Novartis Pharmaceuticals Corp, Teva Neuroscience, Inc.,Genzyme, Sanofi, Celgene, Cognition Pharmaceuticals, Inc., Elsevier, NIH, and NMSS. Dr. Selmaj has received personal compensation for activities with Biogen Idec, Novartis, TEVA Pharmaceuticals, Roche Diagnostics Corporation, Genzyme, Synthon, Receptos, and Bayer for serving on the Scientific Advisory Board. Dr. Klingelschmitt holds stock and/or stock options in F. Hoffmann-La Roche, Ltd., which sponsored research in which Dr. Klingelschmitt was involved as an investigator. Dr. Masterman holds stock and/or stock options in Genentech, which sponsored research in which Dr. Masterman was involved as an investigator. Dr. Fontoura has received personal compensation for activities with.F. Hoffmann-La Roche as an employee. Dr. Chin has received personal compensation for activities with Genentech, Inc. as an employee. Dr. Garren has received personal compensation for activities with F. Hoffmann-La Roche as an employee. Dr. Hauser has received personal compensation for activities with Annexon, Symbiotix, Bionure as a scientific advisory board member and from F. Hoffmann-La Roche Ltd.