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B-cell depletion with rituximab in relapsing-remitting multiple sclerosis
Stephen L Hauser1, Emmanuelle Waubant, Douglas L Arnold
1Department of Neurology, University of California at San Francisco, San Francisco, CA 94143-0114, USA. hausers@neurology.ucsf.edu
The New England Journal of Medicine
|February 15, 2008
Summary
Rituximab significantly reduced brain lesions and relapses in multiple sclerosis patients over 48 weeks. This study supports B-cell targeting as a therapeutic strategy for this condition.
Area of Science:
- Neuroimmunology
- Clinical Therapeutics
Background:
- B lymphocytes play a role in multiple sclerosis (MS) pathogenesis.
- Rituximab, a CD20+ B-cell depleting monoclonal antibody, is a potential therapeutic agent for MS.
Purpose of the Study:
- To evaluate the efficacy and safety of rituximab in patients with relapsing-remitting multiple sclerosis (RRMS).
Main Methods:
- A 48-week, phase 2, double-blind, placebo-controlled trial.
- 104 RRMS patients received either intravenous rituximab (n=69) or placebo (n=35) on days 1 and 15.
- Primary endpoint: count of gadolinium-enhancing MRI lesions; secondary endpoints: relapse rates and safety.
Main Results:
- Rituximab significantly reduced total and new gadolinium-enhancing lesions compared to placebo at weeks 12-24 and sustained to 48 weeks (P<0.001).
- The proportion of patients experiencing relapses was significantly lower in the rituximab group at weeks 24 (14.5% vs 34.3%, P=0.02) and 48 (20.3% vs 40.0%, P=0.04).
- More mild-to-moderate adverse events occurred within 24 hours after the first rituximab infusion; similar events occurred after the second infusion.
Conclusions:
- A single course of rituximab effectively reduced inflammatory brain lesions and clinical relapses in RRMS for 48 weeks.
- The findings provide further evidence for B-cell involvement in the pathophysiology of RRMS.
- Long-term safety and rare adverse events were not assessed in this trial.
