Effects of Anti-CD20 Monoclonal Antibodies in Human Multiple Sclerosis
A review of 11 randomized controlled trials involving 5911 participants showed that anti-CD20 monoclonal antibodies significantly reduced clinical relapses, gadolinium-enhancing (Gd+) lesions, new T2 lesions, and worsening of the Expanded Disability Status Scale (EDSS). However, serious adverse event rates were similar across groups.
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- #MSResearch
- Most relevant to
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Why it matters
This systematic review confirms that anti-CD20 therapies can provide substantial benefits in terms of relapse prevention and MRI markers of disease activity in patients with relapsing multiple sclerosis.
What this does not prove
The association of MRI outcome variability with trial design and comparator differences does not establish causation, indicating a need for further investigation into these factors.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Systematic review
- Participants / samples
- 5911 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Yes
- Relevant MS type
- RRMS
- Publication date
- 2026-09-09
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
- Primary evidenceAnti-CD20 monoclonal antibody therapies in relapsing multiple sclerosis: A systematic review and meta-analysis of randomised controlled trials. ↗DOI: 10.1016/j.msard.2026.107919
Supporting passages (15)
study phaseThis meta-analysis synthesises evidence from all available randomised controlled trials (RCTs) comparing anti-CD20 agents with active or placebo comparators.
study designThis meta-analysis synthesises evidence from all available randomised controlled trials (RCTs) comparing anti-CD20 agents with active or placebo comparators.
subjectsRESULTS: Eleven RCTs (N = 5911) were included, comprising ten trials of anti-CD20 therapy against placebo or a non-anti-CD20 active comparator and the first head-to-head trial of two anti-CD20 agents (OVERLORD-MS, rituximab vs ocrelizumab).
sample sizeRESULTS: Eleven RCTs (N = 5911) were included, comprising ten trials of anti-CD20 therapy against placebo or a non-anti-CD20 active comparator and the first head-to-head trial of two anti-CD20 agents (OVERLORD-MS, rituximab vs ocrelizumab).
randomizedRESULTS: Eleven RCTs (N = 5911) were included, comprising ten trials of anti-CD20 therapy against placebo or a non-anti-CD20 active comparator and the first head-to-head trial of two anti-CD20 agents (OVERLORD-MS, rituximab vs ocrelizumab).
controlledRESULTS: Eleven RCTs (N = 5911) were included, comprising ten trials of anti-CD20 therapy against placebo or a non-anti-CD20 active comparator and the first head-to-head trial of two anti-CD20 agents (OVERLORD-MS, rituximab vs ocrelizumab).
peer reviewedJournal: Multiple sclerosis and related disorders
primary endpoint metAnti-CD20 agents reduced clinical relapses (RR 0.48, 95% CI 0.43-0.52; I² = 24%; p < 0.001; I² = 0% when the head-to-head trial was excluded), Gd+ lesions (RR 0.07, 95% CI 0.03-0.18; I² = 95%; p < 0.001), new T2 lesions (RR 0.24, 95% CI 0.17-0.34; I² = 78%; p < 0.001), and EDSS worsening (RR 0.71, 95% CI 0.62-0.82; I² = 0%; p < 0.001).
relevant ms typesCONCLUSION: Anti-CD20 mAbs confer consistent, clinically meaningful reductions in relapse rate and MRI disease activity.
publication datePublication date: 2026-09-09
interventionRCTs of rituximab, ocrelizumab, ofatumumab, ublituximab, or divozilimab in relapsing MS were eligible, including head-to-head comparisons of two anti-CD20 agents.
comparatorRESULTS: Eleven RCTs (N = 5911) were included, comprising ten trials of anti-CD20 therapy against placebo or a non-anti-CD20 active comparator and the first head-to-head trial of two anti-CD20 agents (OVERLORD-MS, rituximab vs ocrelizumab).
primary endpointPrimary outcome was the clinical relapse risk ratio (RR).
findingsAnti-CD20 agents reduced clinical relapses (RR 0.48, 95% CI 0.43-0.52; I² = 24%; p < 0.001; I² = 0% when the head-to-head trial was excluded), Gd+ lesions (RR 0.07, 95% CI 0.03-0.18; I² = 95%; p < 0.001), new T2 lesions (RR 0.24, 95% CI 0.17-0.34; I² = 78%; p < 0.001), and EDSS worsening (RR 0.71, 95% CI 0.62-0.82; I² = 0%; p < 0.001).
limitationsStratified analyses associated the MRI-outcome heterogeneity with trial programme design and comparator differences rather than with inconsistent drug performance.
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