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

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.

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.

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.

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.

https://inplasy.com/inplasy-2026-6-0022/, identifier INPLASY202660022.