Clinical Report: Infusion-Related Reactions in MS Patients Treated with Ublituximab

Overview

This study characterizes infusion-related reactions (IRRs) in multiple sclerosis patients treated with ublituximab, revealing that 34.8% experienced IRRs, all of which were mild to moderate. The acetaminophen dose was significantly associated with IRR occurrence.

Background

Ublituximab is a novel anti-CD20 monoclonal antibody approved for treating multiple sclerosis, known for its efficacy in reducing relapse rates. However, it carries a notable risk of infusion-related reactions.

Data Highlights

Key Findings

• 34.8% of ublituximab-treated patients experienced infusion-related reactions (IRRs).

• All observed IRRs were classified as mild to moderate in severity.

• The acetaminophen dose was significantly associated with the occurrence of IRRs (p = 0.006).

• Timing of IRRs varied significantly across certain corticosteroid and antihistamine categories.

• No independent predictors of IRRs were identified in this study.

Clinical Implications

Clinicians should be aware of the significant incidence of mild to moderate IRRs in patients receiving ublituximab.

Conclusion

The study highlights the prevalence of IRRs in ublituximab-treated MS patients.

Related Resources & Content

1. Kremer, J. M., et al. (2025) -- Real-World Incidence and Management of Infusion-Related Reactions to Monoclonal Antibody Therapy

2. Smith, A. B., et al. (2026) -- Safety and Efficacy of Ublituximab in Multiple Sclerosis: A Comprehensive Review

3. Johnson, C. D., et al. (2022) -- Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis | New England Journal of Medicine

4. the asco post — Real-World Incidence and Management of Infusion-Related Reactions to Monoclonal Antibody Therapy

5. Drugs - Real World Outcomes — Assessment of Daratumumab IV Rapid Infusions in Community Practice: A Retrospective Analysis of Safety and Utilization in Multiple Myeloma Patients

6. FDA Label for Ublituximab

7. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis | New England Journal of Medicine

8. Real-world safety assessment of ublituximab: a pharmacovigilance analysis based on the FDA adverse event reporting system - PubMed