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Area of Science:

  • Neuroimmunology
  • Clinical Pharmacology

Background:

  • Multiple sclerosis (MS) presents a significant socioeconomic burden, with relapsing-remitting MS (RRMS) affecting over 80% of patients.
  • B lymphocytes play a role in MS pathophysiology, making B-cell depletion a therapeutic target.
  • Novel treatments with improved efficacy and safety profiles are needed for RRMS management.

Purpose of the Study:

  • To assess the safety and effectiveness of rituximab compared to placebo or approved disease-modifying drugs (DMDs) for RRMS.
  • To evaluate rituximab's impact on reducing disease activity in RRMS patients.

Main Methods:

  • Systematic review of randomized, double-blind, controlled clinical trials with at least one year of follow-up.
  • Searched specialized registers, references, and contacted researchers and pharmaceutical companies for relevant trials.
  • Included trials evaluating rituximab as monotherapy or combination therapy versus placebo or approved DMDs for RRMS.

Main Results:

  • One trial with 104 RRMS patients showed rituximab significantly reduced gadolinium-enhancing lesions and relapse rates at 24 weeks, but not at 48 weeks.
  • High attrition bias (24%) was noted at week 48.
  • Adverse events, mostly mild-to-moderate, were more frequent with rituximab, including infusion-associated reactions and infections like sinusitis and urinary tract infections.

Conclusions:

  • Limited evidence from a single, small trial with high attrition bias prevents definitive conclusions on rituximab's efficacy for RRMS.
  • Short-term use of rituximab appears safe, with common mild-to-moderate infusion reactions and infections.
  • Further large-scale, high-quality studies are necessary to confirm rituximab's benefits and long-term safety in RRMS treatment.