{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T05:01:49Z","timestamp":1781154109540,"version":"3.54.1"},"reference-count":84,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:00:00Z","timestamp":1781136000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixty-six studies (24,000 patients) were included. The overall pooled infection incidence was 13.08% (95% CI: 9.85\u201317.18%), 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Systematic review registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/inplasy.com\/inplasy-2026-6-0022\/<\/jats:ext-link>\n                      , identifier INPLASY202660022.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1806488","type":"journal-article","created":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T04:40:52Z","timestamp":1781152852000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and 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