11-Year Data Support Sustained Efficacy and Safety of Ocrelizumab in MS
At CMSC 2025, researchers presented 11-year follow-up data confirming the long-term efficacy and safety of ocrelizumab (OCR) in people with multiple sclerosis (pwMS), including both relapsing (pwRMS) and primary progressive (pwPPMS) forms of the disease. Ocrelizumab, an anti-CD20 monoclonal antibody, has been widely used since its approval, and this analysis leveraged data from completed and ongoing clinical trials and open-label extensions through November 2023 to evaluate its sustained clinical impact.
The study found that, after more than a decade on treatment, 74.9% of pwRMS remained free from 48-week confirmed disability progression (48W-CDP) as measured by the Expanded Disability Status Scale (EDSS), and 91.7% did not require a walking aid. Among those with primary progressive disease, 33.5% remained free from 48W-CDP–EDSS, and 17.8% were free from composite CDP; notably, 79.5% did not progress to wheelchair dependence. Patients who began OCR treatment earlier had a significantly lower risk of reaching disability milestones than those who started later, underscoring the importance of timely intervention.
Over the course of treatment, no new safety concerns were identified. More than 60% of patients received at least 8 doses of OCR, and adverse event (AE) rates remained stable throughout the follow-up. Excluding COVID-19–related events, the AE rate was 223 per 100 patient-years (PY) in pwRMS and 213 per 100 PY in progressive MS, with serious AEs occurring at rates of 5.9 and 10.8 per 100 PY, respectively. Infections were the most commonly reported AE, primarily urinary and respiratory, and were generally mild. Serious infections occurred at a rate of 1.7 per 100 PY in pwRMS and 3.7 per 100 PY in progressive MS, while non-serious infections were reported at rates of 63.8 and 57.1 per 100 PY, respectively. Most patients who experienced infections had only one recurrence.
These long-term findings support the continued use of ocrelizumab as a foundational therapy in MS, with durable benefits in reducing disability progression and a stable, manageable safety profile over more than a decade of treatment.
Reference
Bermel R, Kappos L, Weber S. Ocrelizumab treatment in multiple sclerosis: 11-year efficacy and safety clinical trial data. Presented at: CMSC 2025; May 28-31; Phoenix, AZ.
