ArticleDrugs - real world outcomes2026
Real-World Effectiveness and Safety of Ofatumumab in Relapsing Multiple Sclerosis: Comparison of Treatment-Naïve Patients and Switchers in a Multicenter Cohort.
Article in Drugs - real world outcomes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundOfatumumab (OFA) is a fully human anti-CD20 monoclonal antibody approved for the treatment of relapsing multiple sclerosis (RMS). Real-world data on its effectiveness and safety remain limited.
objectiveTo assess the effectiveness and safety of OFA in a large Italian RMS cohort and to examine the impact of prior treatment exposure on clinical, radiological, and safety outcomes in routine clinical practice.
methodsThis retrospective, multicenter study included adults with RMS who initiated OFA and had at least one follow-up visit. Patients were classified as treatment-naïve, switching from moderate-efficacy therapies (MET), or switching from high-efficacy therapies (HET). Outcomes included annualized relapse rate (ARR), magnetic resonance imaging (MRI) activity, disability measures (including confirmed disability worsening and improvement), no evidence of disease activity (NEDA-3), and adverse events (AEs).
resultsA total of 424 patients were analyzed, with a mean follow-up of 1.32 (± 0.61) years: 101 (23.8%) treatment-naïve and 323 (76.2%) switchers, of whom 113 were previously treated with MET and 210 with HET. During treatment, ARR decreased significantly from 0.486 to 0.027 (94.5% reduction; p < 0.001), with comparable relative reduction observed across all subgroups. MRI activity was significantly diminished, and at 12 months, 79.3% of evaluable patients achieved NEDA-3, with no significant differences between naïve, MET, and HET subgroups. Overall, OFA was well tolerated, with predominantly mild injection-related reactions and low discontinuation rates, mainly related to pregnancy planning with favorable outcomes. Infections were the only safety outcome that differed significantly among groups, occurring in 0.9% of naïve patients, 1.7% of MET switchers, and 9.5% of HET switchers (p = 0.001). Prior exposure to HET was the only independent predictor of infections.
conclusionsThese findings support OFA as an effective and generally safe option for RMS across various treatment sequences, while suggesting enhanced infection monitoring in patients switching from HETs.
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