B-cell depletion with rituximab in relapsing-remitting multiple sclerosis
Open accessAbstract
BACKGROUND: There is increasing evidence that B lymphocytes are involved in the pathogenesis of multiple sclerosis, and they may be a therapeutic target. Rituximab, a monoclonal antibody, selectively targets and depletes CD20+ B lymphocytes. METHODS: In a phase 2, double-blind, 48-week trial involving 104 patients with relapsing-remitting multiple sclerosis, we assigned 69 patients to receive 1000 mg of intravenous rituximab and 35 patients to receive placebo on days 1 and 15. The primary end point was the total count of gadolinium-enhancing lesions detected on magnetic resonance imaging scans of the brain at weeks 12, 16, 20, and 24. Clinical outcomes included safety, the proportion of patients who had relapses, and the annualized rate of relapse. RESULTS: As compared with patients who received placebo, patients who received rituximab had reduced counts of total gadolinium-enhancing lesions at weeks 12, 16, 20, and 24 (P<0.001) and of total new gadolinium-enhancing lesions over the same period (P<0.001); these results were sustained for 48 weeks (P<0.001). As compared with patients in the placebo group, the proportion of patients in the rituximab group with relapses was significantly reduced at week 24 (14.5% vs. 34.3%, P=0.02) and week 48 (20.3% vs. 40.0%, P=0.04). More patients in the rituximab group than in the placebo group had adverse events within 24 hours after the first infusion, most of which were mild-to-moderate events; after the second infusion, the numbers of events were similar in the two groups. CONCLUSIONS: A single course of rituximab reduced inflammatory brain lesions and clinical relapses for 48 weeks. This trial was not designed to assess long-term safety or to detect uncommon adverse events. The data provide evidence of B-cell involvement in the pathophysiology of relapsing-remitting multiple sclerosis. (ClinicalTrials.gov number, NCT00097188 [ClinicalTrials.gov].).
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The strong efficacy of anti-CD20 therapies especially in relapsing disease implies that pathogenic B cell functions extend beyond antibody secretion and underline the importance of B cells for multiple sclerosis pathogenesis.
“However, the strong efficacy of anti-CD20 therapies especially in relapsing disease implies that pathogenic B cell functions extend beyond antibody secretion and underline the importance of B cells for MS pathogenesis [54, 55].”
From Insights and challenges on animal models for progressive multiple sclerosis (2026) · cites this paper as [55]
13 of 17 patients unresponsive to corticosteroids, plasma exchange, or intravenous immunoglobulin responded to cyclophosphamide, rituximab, or both.
“Furthermore, 13 of 17 patients unresponsive to the above therapies, responded to cyclophosphamide (five), rituximab (six), or both (two; data not shown), drugs that are effective in other immune-mediated disorders of the CNS.29,30”
From Anti-NMDA-receptor encephalitis: case series and analysis of the effects of antibodies (2008) · cites this paper as [29]
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- Authors
- Hauser, S. L., Waubant, E., Arnold, D. L., Vollmer, T., Antel, J., Fox, R. J., Bar-Or, A., Panzara, M., Sarkar, N., Agarwal, S., Langer-Gould, A., & Smith, C. H.
- Affiliations
- University of California, San Francisco (US)
- NeuroRx Research (Canada) (CA)
- Barrow Neurological Institute (US)
- McGill University (CA)
- Cleveland Clinic (US)
- Biogen (United States) (US)
- Genentech (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-02-14
- Volume
- 358
- Issue
- 7
- Pages
- 676-688
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2141111992
- Cited by
- 2,439
- References
- 37
- Citations by year
- 2026: 98 · 2025: 101 · 2024: 93 · 2023: 116 · 2022: 126 · 2021: 140 · 2020: 138 · 2019: 142 · 2018: 122 · 2017: 136 · 2016: 132 · 2015: 129 · 2014: 135 · 2013: 152 · 2012: 140
- FWCI
- 124.87
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Biogen
- Teva Pharmaceutical Industries
- Eisai
- Genentech
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- rituximab, relapsing-remitting multiple sclerosis, B-cell depletion, CD20+ B cells, gadolinium-enhancing lesions, neuroinflammation, clinical relapse, annualized relapse rate, monoclonal antibody therapy, multiple sclerosis pathogenesis
- MeSH terms
- Rituximab, Adolescent, Adult, Antibodies, Monoclonal, B-Lymphocytes, Brain, Double-Blind Method, Female, Gadolinium, Humans, Immunoglobulins, Immunologic Factors, Infusions, Intravenous, Magnetic Resonance Imaging, Male, Middle Aged, Remission Induction, Antigens, CD20, Multiple Sclerosis, Relapsing-Remitting, Antibodies, Monoclonal, Murine-Derived
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