IL-17 inhibitors and inflammatory bowel diseases: a post-marketing study in Vigibase(R).
|アブストラクト||Several gastrointestinal symptoms and chronic inflammatory bowel diseases (IBD) have been reported after therapy with IL-17 inhibitors. To date, however, no study has shown a clear association between these drugs and IBD onset. We searched on Vigibase(R) to investigate reporting prevalence, characteristics, and prognosis of all gastroenterological adverse events in patients treated with IL-17 inhibitors. In total, 1,129 gastrointestinal individual case safety reports (ICSRs) were identified including 850 IBD (42.5% Crohn's 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%), while only one colitis occurred with brodalumab (BRO, 0.1%). Most IBD and colitis cases were detected within six months from therapy start in both SEC (68.8% and 73.5%) and IXE groups (100% and 66.7%). Patients' outcomes were reported in 428 ICSRs (37.9%). Complete or ongoing recovery from symptoms was detected in about two-thirds of patients experiencing IBD (59.5%) or colitis (64.2%), while 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 one with IXE) and two SEC-treated subjects in the colitis group (2.1%). Treatment with IL-17 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.|
|ジャーナル名||Clinical pharmacology and therapeutics|
|投稿者||Petitpain, Nadine; D'Amico, Ferdinando; Yelehe-Okouma, Melissa; Jouzeau, Jean-Yves; Netter, Patrick; Peyrin-Biroulet, Laurent; Gillet, Pierre|
|組織名||Regional Centre of Pharmacovigilance, University Hospital of Nancy,;Vandoeuvre-les-Nancy, France.;Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan,;Italy.;Department of Gastroenterology and Inserm NGERE U1256, University Hospital of;Nancy, University of Lorraine, Vandoeuvre-les-Nancy, France.;Department of Clinical Pharmacology and Toxicology, University Hospital of Nancy,;Ingenierie Moleculaire et Ingenierie Articulaire (IMoPA), UMR-7365 CNRS, Faculte;de Medecine, University of Lorraine and University Hospital of Nancy,|