Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis

Objective To evaluate the infection risk associated with vedolizumab (VDZ) in patients with inflammatory bowel disease and to compare its safety with tumor necrosis factor inhibitors, ustekinumab, and placebo. Methods A systematic search of five databases was conducted from inception to December 2025. Infection outcomes were standardized per CTCAE v5.0. Proportion meta-analyses employed random-effects models with Knapp-Hartung adjustment and prediction intervals; comparative safety was assessed by pooling risk ratios. Meta-regression explored sources of heterogeneity. Results Sixty-six studies (24,000 patients) were included. The overall pooled infection incidence was 13.08% (95% CI: 9.85–17.18%), with respiratory tract infections being the most common (4.25%). Serious systemic and rare infections were infrequent. No significant difference in infection risk was observed between VDZ and TNF inhibitors (RR = 0.91) or placebo (RR = 1.02). VDZ was associated with a significantly higher risk compared with ustekinumab (RR = 1.63). Meta-regression identified study design and geographic region as significant moderators. Conclusion VDZ is associated with a moderate infection risk, primarily consisting of mild respiratory events, and a safety profile broadly comparable to TNF inhibitors and placebo but inferior to ustekinumab. Extreme heterogeneity limits the clinical utility of pooled incidence estimates; comparative risk assessment is essential for therapeutic decision-making. Systematic review registration https://inplasy.com/inplasy-2026-6-0022/ , identifier INPLASY202660022.