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Rituximab may effectively reduce relapses in multiple sclerosis (MS) when used as a first-choice or switching therapy compared to other disease-modifying treatments (DMTs). However, its effect on disability worsening and its use in progressive MS require further investigation, with a slight increase in common infections noted.

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Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Multiple sclerosis (MS) is a leading cause of neurological disability in young adults.
  • Rituximab is frequently used off-label for MS treatment globally, even where on-label therapies exist.

Purpose of the Study:

  • To evaluate the efficacy and safety of rituximab for adults with MS.
  • To assess rituximab's benefits and risks as both an initial treatment ('first choice') and a subsequent therapy ('switching').

Main Methods:

  • Systematic review and meta-analysis of randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs).
  • Searched multiple databases including CENTRAL, MEDLINE, Embase, CINAHL, and trial registers up to January 31, 2021.
  • Assessed risk of bias and certainty of evidence (GRADE) for outcomes like disability worsening, relapses, serious adverse events (SAEs), and infections.

Main Results:

  • Rituximab likely significantly reduces relapses in relapsing MS compared to interferon beta or glatiramer acetate, and may reduce relapses compared to dimethyl fumarate and natalizumab.
  • For progressive MS, rituximab showed little to no difference in disability worsening compared to placebo.
  • Rituximab likely increases the risk of common infections slightly compared to certain other disease-modifying treatments (DMTs), but the absolute risk remains small.

Conclusions:

  • Rituximab may offer favorable comparisons for relapse prevention in relapsing MS against various approved DMTs.
  • Evidence regarding rituximab's effect on disability worsening and its efficacy in progressive MS is limited and uncertain.
  • While rituximab is widely used off-label, robust randomized evidence is limited; real-world data may clarify remaining uncertainties.