Real-world effectiveness of ocrelizumab in relapsing multiple sclerosis: An MSBase registry sub-study
Year: 2025
Type: article
Study design: Observational Study
Abstract: INTRODUCTION: The MSOCR-R study evaluates the long-term effectiveness of ocrelizumab (OCR) in patients with relapsing multiple sclerosis (RMS) in real-world clinical settings. METHODS: MSOCR-R is an ongoing, prospective, longitudinal, observational cohort study of people with RMS newly treated with OCR, using data from the international MSBase registry. The study started in July 2018, and data collected up to October 2023 were analyzed. Outcomes were confirmed disability worsening (CDW), progression independent of relapses (PIRA), and no evidence of disease activity (NEDA-3: absence of relapse, 24-week CDW, or imaging activity). RESULTS: Overall, 1011 patients were enrolled (18.1% initiated OCR first-line therapy; 81.9% switched from previous treatment), with a median time of 3.4 years on OCR treatment. About 67% of patients were females. At OCR initiation, mean age was 41.9 years, median disease duration was 10.4 years, and median Expanded Disability Status Scale score was 3.0. The 4-year Kaplan-Meier probabilities of 24-week CDW or PIRA were 25.2% (95% CI 21.6-29.1) and 21.9% (95% CI 18.3-25.2), respectively. Annualized relapse rate substantially decreased from 0.58 (95% CI 0.53-0.63) before OCR to 0.05 (95% CI 0.04-0.06) after treatment initiation. NEDA-3 was assessed in 366 patients and the probability of achieving NEDA-3 was 39.7% (95% CI 36.0-43.5) at 4 years. Persistence on OCR was 88.0% (95% CI, 85.2-90.3) at 4 years. Better clinical outcomes were consistently observed among the first-line treatment cohort. CONCLUSION: The MSOCR-R study provides strong real-world evidence of OCR effectiveness in people with RMS.
Authors: Helmut Butzkueven, Pamela Farr, Serkan Ozakbas, Cavit Boz, Tomas Kalincik, Lisa Taylor, Anneke Van Der Walt, Raed Alroughani, Katherine Buzzard, Olga Skibina, Jeannette Lechner-Scott, Guy Laureys, Murat Terzi, Vincent Van Pesch, Francois Grand-Maison, Michael Barnett, Allan Kermode, Jose Luis Sanchez Menoyo, Juan Rojas, Barbara Willekens, Matteo Foschi, Cristina Ramo-Tello, Eli Skromne, Petra Dirks, Erwan Muros-Le Rouzic, Tim Spelman
Institutions: Monash University, İzmir University of Economics, Karadeniz Technical University, The Royal Melbourne Hospital, The University of Melbourne, Amiri Hospital, Box Hill Hospital, Eastern Health, University of Newcastle Australia, Ghent University Hospital, Ondokuz Mayıs University, Cliniques Universitaires Saint-Luc, UCLouvain, KU Leuven, The University of Sydney, The University of Western Australia, Hospital de Galdakao, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno, Antwerp University Hospital, Ospedale "Santa Maria delle Croci" di Ravenna, Hospital Universitari Germans Trias i Pujol, Roche (Switzerland), Karolinska Institutet
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,500
Funders: Amgen, Roche, Sanofi, Biogen, Teva Pharmaceutical Industries, Alexion Pharmaceuticals, Celgene, F. Hoffmann-La Roche, European Committee for Treatment and Research in Multiple Sclerosis, Queen Elisabeth Medical Foundation, Multiple Sclerosis Australia, Fonds Wetenschappelijk Onderzoek, Eisai, Fondation Charcot, Multiple Sclerosis International Federation, Neuraxpharm, Novartis Pharma, Medical Research Council, National Health and Medical Research Council
OpenAlex ID: W4416662155