Objective:

To assess the effectiveness and safety of Ofatumumab (OFA) in relapsing multiple sclerosis (RMS), specifically examining clinical, radiological, and safety outcomes, including adverse events and treatment discontinuation.

Approach:

Key Findings:

• Ofatumumab achieved substantial reductions in relapse rate and MRI activity.
• High rates of NEDA-3 were observed across treatment-naïve patients and switchers.
• Disability outcomes remained stable over follow-up with no meaningful differences across treatment subgroups.
• Prior exposure to high-efficacy therapies was the only independent predictor of infection risk under Ofatumumab.

Interpretation:

The findings suggest that Ofatumumab is effective in reducing relapse rates and MRI activity in RMS patients, regardless of prior treatment history.

Limitations:

• The study is retrospective and may be subject to biases inherent in observational studies, such as selection bias and confounding factors.
• Data were collected from a limited number of centers, which may affect generalizability to broader populations.

Conclusion:

Ofatumumab demonstrates effectiveness and safety in a real-world setting for RMS patients, with prior treatment influencing infection risk, suggesting the need for careful consideration in treatment planning.

Source

Based on findings from:

Real-World Effectiveness and Safety of Ofatumumab in Relapsing Multiple Sclerosis: Comparison of Treatment-Naïve Patients and Switchers in a Multicenter Cohort

Vincenzo Mangialardi, Giuseppe Macchitella, Rita Vitobello, Antonella Teofilo, Nicola Cavalli, Caterina Lapucci, Marco Vercellino, Elisa Idini, Jessica Frau, Pietro Iaffaldano, Paola Cavalla, Matilde M. Inglese, Eleonora Cocco, Damiano Paolicelli. Drugs - Real World Outcomes, 2026.

https://link.springer.com/article/10.1007/s40801-026-00558-6

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