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

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

  • By

  • 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

  • May 31, 2026

  • 0 min

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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.

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