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Rituximab for people with multiple sclerosis

Filippini G, Kruja J, Del Giovane C

The Cochrane database of systematic reviews, 2025

6,202 participants · 2 citations

Abstract

Background: Multiple sclerosis (MS) is the most common neurological cause of disability in young adults. Off-label rituximab for MS is used in most countries surveyed by the International Federation of MS, including high-income countries where on-label disease-modifying treatments (DMTs) are available. This updates the 2021 version of the review.

Objectives: To assess the benefits and harms of rituximab as 'first choice' and 'switching' treatment for adults with any form of MS.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, and three trials registers on 31 December 2023, together with reference checking and contacting study authors to identify unpublished studies.

Selection criteria: We included randomised controlled trials (RCTs) and controlled non-randomised studies of interventions (NRSIs) comparing rituximab with placebo or another DMT for adults with any form of MS.

Data collection and analysis: We followed standard Cochrane methods. We used RoB 1 to assess risk of bias in RCTs and ROBINS-I in NRSIs. We assessed the certainty of evidence for critical and important prioritised outcomes using GRADE: disability worsening, relapse, serious adverse events (SAEs), health-related quality of life (HRQoL), common infections, cancer, and mortality. We conducted separate analyses for rituximab as 'first choice' or as 'switching' treatment, relapsing or progressive MS, comparison with placebo or another DMT, and RCTs or NRSIs.

Main results: In this update, the number…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 6,202 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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