New onset inflammatory bowel disease (IBD) during antiinterleukin (IL)-17 therapy represents a rare but potentially dramatic adverse event (AE). A recent systematic review with meta-analysis by Yamada et al. found no difference in the risk of developing new onset IBD with anti-IL-17 agents compared to placebo [1]. The authors examined 38 randomized controlled trials (RCT) including 16,690 patients treated with anti-IL-17 drugs. A total of 12 cases of new onset IBD associated with anti-IL-17 agents were found in 5 studies, whereas no cases were observed in the placebo arms. The risk of diarrhea was also evaluated due to the possible underdiagnosis of IBD, yet no difference was found either (Mantel-Haenszel risk difference 0.0013, 95% CI: 0.0014-0.0041, p = 0.34). Although Yamada et al. demonstrated a low incidence rate of new onset IBD with anti-IL-17 agents in patients with existing inflammatory or autoimmune diseases (2.4 cases per 1000 patient-year), their findings should be interpreted with caution, as RCTs may not be the best setting to capture AEs, due to strict initial patient selection [1].Indeed, a postmarketing study in Vigibase -a unique WHO global database of individual case safety reports -revealed almost one thousand cases, with no recovery in about one third, significant sequelae and even fatal outcomes. More specifically, 1129 gastrointestinal Individual Case Safety Reports (ICSRs) were reviewed, comprising 850 IBD (42.5% Crohn's disease [CD], 31.9% ulcerative colitis [UC], and 25.6% undifferentiated IBD) and 279 colitis). Secukinumab (SEC, 83.6%) or ixekizumab (IXE, 16.3%) were identified as culprit drugs in 83.6% and 16.3% of total cases, respectively, whereas only one colitis was associated with brodalumab (0.1%). Most IBD and colitis cases occurred within 6 months from treatment initiation in both the SEC (68.8% and 73.5%, respectively) and IXE (100% and 66.7%, respectively) groups. There was no recovery from symptoms in 33.9% and 29.5% of IBD and colitis cases; and sequelae were reported in 5.4% and 4.2% of IBD and colitis cases, respectively. Eight intestinal perforations (0.9%) were observed, including five patients with SEC and three patients with IXE. Most perforations (75%) were CONTACT Carlo Alberto Maronese