| アブストラクト | AIMS: Ocrelizumab is a humanized anti-CD20 monoclonal antibody used in multiple sclerosis. Since its commercialization, several cases of ocrelizumab-induced colitis have been reported in the scientific literature. METHODS: To explore the potential association of ocrelizumab with colitis as an adverse drug reaction (ADR), we conducted a descriptive and disproportionality analysis of ocrelizumab-induced colitis registered in VigiBase, as well as an extensive literature review and a description of two cases from Luxembourg reported to our pharmacovigilance centre. RESULTS: Our VigiBase analysis revealed 400 cases of ocrelizumab-induced colitis, with 79.0% serious cases and a median time to onset of 17 months. The preferred term (PT) coded was 'colitis' (53.0%), followed by PTs related to inflammatory bowel diseases (33.5%). Significant disproportionality was found for high-level term 'colitis' and for 'colitis', 'colitis microscopic' and 'immune-mediated enterocolitis' PTs. Our literature review revealed 24 case reports corresponding to 36 patients with a median time to onset of 18 months and a predominance of unspecified colitis (61.1%) and inflammatory bowel diseases (27.8%). Two patients relapsed after ocrelizumab resumption. CONCLUSIONS: Together, our findings of two relevant clinical cases of ocrelizumab-induced colitis, the literature review and the significant VigiBase disproportionality, suggest a potential safety signal for ocrelizumab. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| Pubmed追加日 | 2026/2/16 |
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| 投稿者 | Fresse, Audrey; Hommel, Christophe; Petitpain, Nadine; Kerschen, Philippe |
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| 組織名 | Regional Pharmacovigilance Center of Nancy, Pharmaco-toxicology Department,;University Hospital of Nancy, Vandoeuvre-les-Nancy, France.;Department of Gastroenterology, Centre Hospitalier Emile Mayrisch, Esch sur;Alzette, Luxembourg.;Department of Neurology, Centre Hospitalier Luxembourg, Luxembourg-Ville,;Luxembourg. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41693080/ |
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