Annualized Relapse Rate and Confirmed Disability Progression in Patients Receiving Continuous Ocrelizumab or Switching From Interferon Beta-1a to Ocrelizumab Therapy in the Open-Label Extension Period of the Phase III Trials of Ocrelizumab in Patients With Relapsing Multiple Sclerosis (P1.366)

Objective: To assess the efficacy of switching to or maintaining ocrelizumab (OCR) therapy on clinical measures of disease activity and progression in the open-label extension (OLE) period of Phase III trials in relapsing multiple sclerosis (RMS). Background: The efficacy and safety of OCR in RMS were demonstrated in the 96-week double-blind control period of OPERA I and II (NCT01247324; NCT01412333). Design/Methods: At the start of the OLE period, patients continued (OCR-OCR) or were switched from interferon-beta-1a (IFNβ1a) to OCR (IFN-OCR). Adjusted annualized relapse rate (ARR), time to onset of 24-week-confirmed disability progression (CDP24) and change in adjusted mean Expanded Disability Status Scale (EDSS) score from baseline were analyzed. Results: More than 89% of patients completed OLE Year 2. Among IFN-OCR patients, ARR decreased from 0.20 in the year pre-switch to 0.10 and 0.08 at Years 1 and 2 post-switch (p Conclusions: Switching from IFNβ1a to ocrelizumab at the start of the OLE period was associated with a rapid and robust reduction in ARR which was maintained through the 2-year follow-up of the OLE period. The benefits of ocrelizumab on ARR and CDP24 as seen in the 2-year double-blind controlled period were maintained after 2 years in the OLE period. 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. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Symbiotix, Annexon, Bionure, Molecular Stethoscope. Dr. Hauser has received compensation for serving on the Board of Directors of Neurona. Dr. Brochet has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Biogen-idec, Genzyme, Medday. Dr. Brochet has received research support from Teva, Biogen, Medday, Novartis, Roche, Actelion, Genzyme, Merck, Bayer. 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. Naismith has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis, Teva. 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. Dr. Manfrini 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. Garas has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with M Garas is an employee and shareholder of F. Hoffmann-La Roche Ltd. Dr. Villoslada has nothing to disclose. Dr. Model 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. Hubeaux has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and shareholder of F. Hoffmann-La Roche Ltd. Dr. Kappos has received research support from Bayer HealthCare Pharmaceuticals, Biogen, F. Hoffmann-La Roche Ltd and Genentech,Novartis, Research grants from: the European Union, Roche Research Foundation, Swiss Multiple Sclerosis Society and Swiss National Research Foundation.