Long-Term Outcomes of Ublituximab Treatment in Multiple Sclerosis: Findings from the ULTIMATE I and II Open-Label Extension Trials - Summary - MDSpire

Long-Term Outcomes of Ublituximab Treatment in Multiple Sclerosis: Findings from the ULTIMATE I and II Open-Label Extension Trials

  • By

  • Bruce A. C. Cree

  • Edward Fox

  • Hans-Peter Hartung

  • Enrique Alvarez

  • Peiqing Qian

  • Sibyl Wray

  • Derrick Robertson

  • Krzysztof Selmaj

  • Daniel Wynn

  • Koby Mok

  • Chris Rowland

  • Karthik Bodhinathan

  • Peter Sportelli

  • Hari P. Miskin

  • Lawrence Steinman

  • April 1, 2026

  • 0 min

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Objective:

To evaluate the long-term safety and efficacy of ublituximab treatment in participants with relapsing forms of multiple sclerosis (RMS) over a 5-year period, highlighting its potential impact on patient outcomes.

Key Findings:
  • Ublituximab demonstrated reduced annualized relapse rates (ARRs) and fewer gadolinium-enhancing lesions compared to teriflunomide, with specific percentages to be included.
  • Long-term treatment showed sustained efficacy in reducing disease activity over 5 years.
  • Adverse events were monitored, with specific exclusions related to COVID-19 to maintain data integrity.
Interpretation:

The findings suggest that ublituximab is effective in maintaining long-term disease control in RMS, with a favorable safety profile, which may influence treatment decisions.

Limitations:
  • Radiographic data were limited due to the COVID-19 pandemic, potentially affecting the robustness of the findings.
  • Potential biases in adverse event reporting due to the exclusion of COVID-related terms.
Conclusion:

Ublituximab offers a promising long-term treatment option for patients with RMS, demonstrating sustained efficacy and manageable safety over five years, warranting ongoing monitoring for safety.

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