Confirmed Disability Progression in Different Subgroups of Patients With Relapsing Multiple Sclerosis Who Received Ocrelizumab or Interferon Beta-1a in the Phase III OPERA I and OPERA II Studies (P1.371)

Objective: To assess ocrelizumab vs interferon beta-1a (IFNβ1a) on 12- and 24-week confirmed disability progression (CDP) in subgroups of the pooled Phase III OPERA I and OPERA II studies (NCT01412333/NCT01247324). Background: Ocrelizumab, a humanized, CD20+ B cell-selective monoclonal antibody, decreased the risk of 12- and 24-week CDP vs IFNβ1a in the overall populations of the individual OPERA studies and in a pooled analysis. Design/Methods: In the OPERA studies, patients received intravenous ocrelizumab 600mg Q24W or subcutaneous IFNβ1a 44μg Q3W for 96 weeks. Time-to-onset of 12- and 24-week CDP was assessed. Between-group hazard ratios and p-values were based on Cox proportional hazards models with study, region and baseline Extended Disability Status Scale (EDSS) score ( Results: Patient characteristics were comparable between treatments and within subgroup strata. The risk reduction (RR; ocrelizumab vs IFNβ1a) for 12-and 24-week CDP in the overall pooled population was 40% (p Conclusions: These subgroup analyses were consistent with the overall pooled population on ocrelizumab reducing the risk of CDP vs IFNβ1a. Study Supported by: Sponsored by F. Hoffmann-La Roche Ltd; Writing and editorial assistance was provided by Health Interactions, USA, and Articulate Science, UK. Disclosure: Dr. Turner has nothing to disclose. Dr. Cree has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, Biogen, EMD Serono, GeNEuro, Novartis, Sanofi Genzyme. Dr. Cree has received research support from Acorda, Hoffman La Roche, MedImmune, Novartis, Receptos and Teva. Dr. Lorscheider has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffman-La Roche Ltd. Dr. Montalban has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Oryzon, Roche, Sanofi and Teva Pharmaceutical. Dr. Papeix has nothing to disclose. Dr. Buffels has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of F. Hoffman-La Roche Ltd. Dr. Masterman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech Inc. Dr. Han has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech Inc. Dr. Levesque has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genentech Inc. Dr. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with has served on advisory boards and data monitoring or steering committees, has held consulting agreements or has received speaker honoraria from AbbVie, Alkermes, Biogen, Bionest, Clene Nanomedicine, EMD Serono, Forward Pharma, MedDay, Pharmaceuticals, Nov. Dr. Wolinsky has received royalty, license fees, or contractual rights payments from royalties for monoclonal antibodies out-licensed to Chemicon International through UTHealth.