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We searched on Vigibase, the worldwide pharmacovigilance database, to investigate reporting prevalence, characteristics, and prognosis of all gastroenterological adverse events in patients treated with IL\u201017 inhibitors. In total, 1,129 gastrointestinal Individual Case Safety Reports (ICSRs) were identified, including 850 IBD (42.5% Crohn\u2019s disease, 31.9% ulcerative colitis, and 25.6% undifferentiated IBD) and 279 colitis (mainly undifferentiated colitis (79.2%), and microscopic colitis (10.4%)). ICSRs were associated with secukinumab (SEC, 83.6%) or ixekizumab (IXE, 16.3%), whereas only one colitis occurred with brodalumab (0.1%). Most IBD and colitis cases were detected within 6\u00a0months from therapy start in both the SEC (68.8% and 73.5%) and IXE groups (100% and 66.7%). Patients\u2019 outcomes were reported in 428 ICSRs (37.9%). Complete or ongoing recovery from symptoms was detected in about two\u2010thirds of patients experiencing IBD (59.5%) or colitis (64.2%), whereas in the other cases, there was no recovery (33.9% and 29.5%) or there were sequelae (5.4% and 4.2%). Fatal events occurred in four patients (1.2%) in the IBD group (3 after SEC and on1e with IXE) and two SEC\u2010treated subjects in the colitis group (2.1%). Treatment with IL\u201017 inhibitors is associated with a relevant number of exacerbations and new onset of IBD and colitis. Careful evaluation of gastrointestinal symptoms and the monitoring of intestinal inflammatory biomarkers should be recommended before prescribing these drugs.<\/jats:p>","DOI":"10.1002\/cpt.2155","type":"journal-article","created":{"date-parts":[[2021,1,10]],"date-time":"2021-01-10T19:20:46Z","timestamp":1610306446000},"page":"159-168","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":53,"title":["IL\u201017 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase"],"prefix":"10.1111","volume":"110","author":[{"given":"Nadine","family":"Petitpain","sequence":"first","affiliation":[{"name":"Regional Centre of Pharmacovigilance University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferdinando","family":"D\u2019Amico","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences Humanitas University Milan Italy"},{"name":"Department of Gastroenterology and Inserm NGERE U1256 University Hospital of Nancy University of Lorraine Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Yelehe\u2010Okouma","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Yves","family":"Jouzeau","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Toxicology University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"},{"name":"Ing\u00e9nierie Mol\u00e9culaire et Ing\u00e9nierie Articulaire (IMoPA) UMR\u20107365 CNRS Facult\u00e9 de M\u00e9decine University of Lorraine and University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Netter","sequence":"additional","affiliation":[{"name":"Ing\u00e9nierie Mol\u00e9culaire et Ing\u00e9nierie Articulaire (IMoPA) UMR\u20107365 CNRS Facult\u00e9 de M\u00e9decine University of Lorraine and University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin\u2010Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Inserm NGERE U1256 University Hospital of Nancy University of Lorraine Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Gillet","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"},{"name":"Ing\u00e9nierie Mol\u00e9culaire et Ing\u00e9nierie Articulaire (IMoPA) UMR\u20107365 CNRS Facult\u00e9 de M\u00e9decine University of Lorraine and University Hospital of Nancy Vandoeuvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,2,12]]},"reference":[{"key":"e_1_2_10_1_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.immuni.2008.03.004"},{"key":"e_1_2_10_2_1","unstructured":"Anonymous.Cosentyx. 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