{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:28:37Z","timestamp":1787239717243,"version":"build-2736575974"},"reference-count":51,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,2,15]],"date-time":"2026-02-15T00:00:00Z","timestamp":1771113600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,2,15]],"date-time":"2026-02-15T00:00:00Z","timestamp":1771113600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Ocrelizumab is a humanized anti\u2010CD20 monoclonal antibody used in multiple sclerosis. Since its commercialization, several cases of ocrelizumab\u2010induced colitis have been reported in the scientific literature.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>To explore the potential association of ocrelizumab with colitis as an adverse drug reaction (ADR), we conducted a descriptive and disproportionality analysis of ocrelizumab\u2010induced colitis registered in VigiBase, as well as an extensive literature review and a description of two cases from Luxembourg reported to our pharmacovigilance centre.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Our VigiBase analysis revealed 400 cases of ocrelizumab\u2010induced colitis, with 79.0% serious cases and a median time to onset of 17\u2009months. The preferred term (PT) coded was \u2018colitis\u2019 (53.0%), followed by PTs related to inflammatory bowel diseases (33.5%). Significant disproportionality was found for high\u2010level term \u2018colitis\u2019 and for \u2018colitis\u2019, \u2018colitis microscopic\u2019 and \u2018immune\u2010mediated enterocolitis\u2019 PTs. Our literature review revealed 24 case reports corresponding to 36 patients with a median time to onset of 18\u2009months and a predominance of unspecified colitis (61.1%) and inflammatory bowel diseases (27.8%). Two patients relapsed after ocrelizumab resumption.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Together, our findings of two relevant clinical cases of ocrelizumab\u2010induced colitis, the literature review and the significant VigiBase disproportionality, suggest a potential safety signal for ocrelizumab.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70490","type":"journal-article","created":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T09:27:38Z","timestamp":1771234058000},"page":"2162-2170","source":"Crossref","is-referenced-by-count":2,"title":["Ocrelizumab\u2010induced colitis: VigiBase disproportionality analysis, case reports and literature review"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7876-9846","authenticated-orcid":false,"given":"Audrey","family":"Fresse","sequence":"first","affiliation":[{"name":"Regional Pharmacovigilance Center of Nancy, Pharmaco\u2010toxicology Department University Hospital of Nancy  Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Hommel","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Centre Hospitalier Emile Mayrisch  Esch sur Alzette Luxembourg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadine","family":"Petitpain","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Nancy, Pharmaco\u2010toxicology Department University Hospital of Nancy  Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Kerschen","sequence":"additional","affiliation":[{"name":"Department of Neurology Centre Hospitalier Luxembourg  Luxembourg\u2010Ville Luxembourg"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000012700"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/antib11010017"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/acn3.51495"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2023.104763"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/COC.0000000000000553"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365521.2020.1854847"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.11.043"},{"key":"e_1_2_10_9_1","unstructured":"Eland S Lemmers A Delhaye Met alSecondary autoimmune diseases following ocrelizumab therapy for multiple sclerosis In: ECF Annual Meeting. 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