Safety of Vedolizumab in Pregnancy

BACKGROUND: Vedolizumab is increasingly used as an advanced therapy for inflammatory bowel disease (IBD), with increasing use among reproductive-aged individuals. We aimed to evaluate the safety of vedolizumab during pregnancy by synthesizing recent evidence on maternal, fetal, and neonatal outcomes. METHODS: A systematic review and meta-analysis was conducted following PRISMA guidelines. 5 databases were searched from inception to June 26, 2025 for cohort studies and randomized control trials evaluating vedolizumab exposure during pregnancy in individuals with IBD. Outcomes of interest included live birth, preterm birth, early pregnancy loss, cesarean delivery, congenital malformations, small for gestational age (SGA), and composite perinatal complications. Random-effects meta-analyses were performed using the restricted maximum likelihood estimator. RESULTS: Eight cohort studies (5 prospective, 3 retrospective) met inclusion criteria. Vedolizumab exposure was associated with increased odds of preterm birth (pooled OR=1.33; 95% CI: 1.12-1.59; I²=74.1%) and cesarean delivery (OR=1.27; 95% CI: 1.03-1.57; I²=0%), but not with early pregnancy loss (OR=0.96; 95% CI: 0.54-1.71), congenital malformations (OR=1.42; 95% CI: 0.86-2.34), SGA (OR=1.10; 95% CI: 0.70-1.73), or composite perinatal complications (OR=2.00; 95% CI: 0.98-4.10). CONCLUSIONS: Vedolizumab exposure during pregnancy in individuals with IBD was not associated with increased odds of early pregnancy loss, congenital malformations, or composite perinatal complications. However, increased odds of preterm birth and cesarean delivery were observed, potentially reflecting underlying disease severity.