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Ocrelizumab-induced colitis: VigiBase disproportionality analysis, case reports and literature review

Audrey Fresse1, Christophe Hommel2, Nadine Petitpain1

  • 1Regional Pharmacovigilance Center of Nancy, Pharmaco-toxicology Department, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.

British Journal of Clinical Pharmacology
|February 16, 2026
PubMed
Abstract

Insights

Ocrelizumab, used for multiple sclerosis, may be associated with colitis. Analysis of adverse drug reactions and literature suggests a potential safety signal for this anti-CD20 antibody.

Area of Science:

  • Pharmacovigilance
  • Immunology
  • Gastroenterology

Background:

  • Ocrelizumab is a targeted therapy for multiple sclerosis.
  • Post-marketing surveillance has identified cases of colitis linked to ocrelizumab.
  • Understanding this potential adverse drug reaction is crucial for patient safety.

Purpose of the Study:

  • To investigate the association between ocrelizumab and colitis.
  • To evaluate colitis as a potential adverse drug reaction (ADR) of ocrelizumab.
  • To analyze pharmacovigilance data and literature for safety signals.

Main Methods:

  • Descriptive and disproportionality analysis of VigiBase data for ocrelizumab-induced colitis.
  • Comprehensive literature review of reported cases.
  • Case series description from Luxembourg pharmacovigilance center.

Main Results:

  • VigiBase analysis identified 400 cases of ocrelizumab-induced colitis, with 79% serious and a median onset of 17 months.
  • Significant disproportionality for 'colitis' and related terms, including microscopic colitis and immune-mediated enterocolitis.
  • Literature review found 24 case reports (36 patients), with a median onset of 18 months; two patients relapsed upon re-exposure.

Conclusions:

  • Clinical cases, literature review, and VigiBase data suggest a potential safety signal for ocrelizumab-induced colitis.
  • The findings highlight the importance of monitoring for gastrointestinal adverse events in patients treated with ocrelizumab.
  • Further research may be warranted to elucidate the mechanisms and incidence of this ADR.
Keywords:
adverse drug reactioncolitisdisproportionality analysisocrelizumabpharmacovigilance

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