Real-world data confirms the effectiveness and safety of ofatumumab in MS

A real-world study confirms the favourable benefit-risk ratio of ofatumumab. The findings demonstrated a rapid and sustained control of disease activity and disability progression from the first year of treatment, supporting early treatment initiation with this anti-CD20 monoclonal antibody.

Real-world data on ofatumumab is still limited. Dr Gina Ferrazzano (Sapienza University of Rome, Italy) and colleagues performed a retrospective analysis of data from 12 Italian MS clinics to evaluate the efficacy and safety of ofatumumab over a period of 12 months [1]. The study included patients with relapsing MS who started ofatumumab treatment between April 2022 and January 2024.

A total of 242 participants were included. Their mean age was 39 years; 163 (67%) were women; mean disease duration was 7.7 years; and mean baseline Expanded Disability Status Scale (EDSS) score was 2. Of the 242 participants, 147 switched to ofatumumab and 95 were treatment-naïve. The lack of efficacy of the previous treatment was the reason for switching to ofatumumab in 89 (61%) of 147 participants; 43 (29%) switched for safety reasons, 12(8.3%) for tolerability issues and 3(2%) for other reasons.

The EDSS score remained stable during follow-up (P>0.05) and was 1.5 after 12 months. Only 4 patients (1.6%) experienced a clinical relapse, all within the first 6 months, with a mean time to relapse of 3.0 months. Annualised relapse rate significantly decreased from 0.9 in the last 12 months before ofatumumab treatment to 0.02 after 12 months of ofatumumab (P<0.001). MRI activity was detected in 10 patients (4.1%) within 6 months (4 with gadolinium-enhancing lesions), and in 3 of the 77 participants (3.8%) who completed MRI assessment at 12 months.

Ofatumumab was generally well-tolerated, Dr Ferrazzano noted. The most commonly reported adverse events were flu-like symptoms after the first administration (34.3%), infections (18.5%), and injection-site reactions (8.2%).

Dr Ferrazzano added that data collection was ongoing to assess sustained efficacy and safety at 24 months. A total of 103 patients had reached the 24-month follow-up.

1. Ferrazzano G, et al. Real-world effectiveness and safety of ofatumumab in multiple sclerosis: data from a 12-month follow-up study. OPR-038, EAN Congress 2025, 21-24 June, Helsinki, Finland.

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Posted on 3 September 2025