Immune-mediated colitis associated with ocrelizumab: A new safety risk

• Published in: Multiple sclerosis Vol. 29; no. 10; pp. 1275 - 1281
• Main Authors: Kim, Tiffany, Brinker, Allen, Croteau, David, Lee, Paul R, Baldassari, Laura E, Stevens, Jessica, Hughes, Alice, Tomaino, Juli, deFonseka, Arushi, Altepeter, Tara, Kortepeter, Cindy M
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-09-2023; Sage Publications Ltd
• Subjects: Adverse events; Crohn's disease; Immune checkpoint inhibitors; Immunomodulation; Inflammatory bowel disease; Inflammatory bowel diseases; Ischemia; Multiple sclerosis; Rituximab; Ulcerative colitis; Multiple sclerosis; ocrelizumab; colitis
• ISSN: 1352-4585; 1477-0970; 1477-0970
• DOI: 10.1177/13524585231195854

Background:
An association between certain immunomodulatory therapies (rituximab, ipilimumab, and other immune checkpoint inhibitors) and inflammatory (non-ischemic and non-infectious) colitis in oncologic and non-oncologic patient populations is well documented in the medical literature.
Objective:
The purpose of this case series is to describe adverse event reports of new onset, inflammatory colitis in association with ocrelizumab in patients with multiple sclerosis submitted to U.S. Food and Drug Administration (FDA) or published in the medical literature.
Methods:
The FDA Adverse Event Reporting System (FAERS) and medical literature were searched.
Results:
A review of postmarketing cases from FAERS and published medical literature identified 38 cases consistent with inflammatory, non-ischemic, and non-infectious colitis in association with ocrelizumab. The median time-to-onset was 8 months. Cases were reported using the following diagnostic terms: Crohn’s disease (13), unspecified colitis (11), microscopic colitis (5), ulcerative colitis (5), medication-induced colitis (3), and autoimmune colitis (2).
Conclusions:
This case series highlights ocrelizumab induced immune-mediated colitis that can be clinically severe and potentially life-threatening. Based on the findings of this review, the ocrelizumab Prescribing Information was amended to include immune-mediated colitis in the Warnings and Precautions section.