Clinical Report: Now Enrolling Real-World Registry Study of BRUMVI

Overview

Baptist Health Brain & Spine Care is conducting a real-world registry study to evaluate the outcomes, safety, and patient experience of BRUMVI (ublituximab-xiiy) in patients with relapsing multiple sclerosis. This observational study aims to gather data on the therapy's performance in everyday clinical practice, highlighting its significance in real-world settings.

Background

Understanding the real-world effectiveness and safety of therapies like BRUMVI is crucial for clinicians, as randomized trials often do not reflect everyday practice. This registry will provide valuable insights into patient outcomes and experiences over time, enhancing the understanding of BRUMVI's role in treating relapsing multiple sclerosis. The study's findings may inform clinical decision-making and patient management strategies, such as adjusting treatment plans based on real-world data.

Data Highlights

No numerical data available in the source material due to the observational nature of the study.

Key Findings

• The registry is observational and non-interventional, focusing on real-world data collection.
• Participants will share health information and complete questionnaires while receiving standard care, contributing to a comprehensive understanding of treatment outcomes.
• Eligibility includes confirmed multiple sclerosis diagnosis and no prior BRUMVI infusions.
• Key exclusions involve recent vaccinations and active infections.
• The study aims to track outcomes over a total of 192 weeks of therapy.

Clinical Implications

Clinicians should consider referring eligible patients with relapsing multiple sclerosis who are starting BRUMVI to this registry. Participation may enhance understanding of the therapy's real-world effectiveness and safety, contributing to improved patient care and offering potential benefits for patients.

Conclusion

This registry study represents an important step in evaluating BRUMVI's performance in a real-world setting, potentially guiding future clinical practices in managing relapsing multiple sclerosis and influencing treatment strategies.

References

1. Baptist Health Brain & Spine Care, Now Enrolling, 2023 -- Real-World Registry Study of BRUMVI
2. Drug Safety — Opportunities and Obstacles in Pharmacovigilance through Registry Data in Multiple Sclerosis: Insights Gained from the REGIMS Multicenter Initiative, 2020
3. Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study | Trials | JAMA Neurology, 2026
4. First-Line Use of Higher-Efficacy Disease-Modifying Therapies in Multiple Sclerosis: Canadian Consensus Recommendations, 2025
5. Retinal Physician — Clinical Trials Update
6. Retinal Physician — Clinical Trial Update October 2022
7. Retinal Physician — CLINICAL TRIAL UPDATE
8. These highlights do not include all the information needed to use BRIUMVI safely and effectively. See full prescribing information for BRIUMVI. BRIUMVI ®(ublituximab-xiiy) injection, for intravenous use Initial U.S. Approval: 2022
9. Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study | Trials | JAMA Neurology | JAMA Network
10. First-Line Use of Higher-Efficacy Disease-Modifying Therapies in Multiple Sclerosis: Canadian Consensus Recommendations | Canadian Journal of Neurological Sciences | Cambridge Core