Vedolizumab, a gut-selective monoclonal antibody targeting α4β7 integrin, is widely used for the treatment of Crohn’s disease and ulcerative colitis, but safety data during pregnancy have been limited. This prospective observational study from the Vedolizumab Pregnancy Exposure Registry (2015–2022) evaluated pregnancy outcomes among women exposed to vedolizumab.
Vedolizumab, a gut-selective monoclonal antibody targeting α4β7 integrin, is widely used for the treatment of Crohn’s disease and ulcerative colitis, but safety data during pregnancy have been limited. This prospective observational study from the Vedolizumab Pregnancy Exposure Registry (2015–2022) evaluated pregnancy outcomes among women exposed to vedolizumab.
The registry included 275 pregnant women from the United States and Canada, divided into three groups: vedolizumab-exposed (n=99), disease-matched women receiving other biologics (n=76), and healthy unexposed controls (n=100). Mothers and infants were followed for one year postpartum, assessing major birth defects, pregnancy loss, preterm delivery, infections, growth abnormalities, malignancies, and developmental milestones.
Among pregnancies resulting in live births, major birth defects occurred in 7.4% of vedolizumab-exposed infants compared with 5.6% in the disease-matched biologic group, showing no statistically significant difference (adjusted risk ratio 1.07). Similarly, rates of spontaneous abortion and preterm delivery were not significantly increased in the vedolizumab group. No increased risk was observed for infections, growth abnormalities, or developmental outcomes in infants.
Overall, the registry found no significant safety signals associated with vedolizumab exposure during pregnancy. These findings provide reassuring prospective evidence supporting the continued use of vedolizumab in pregnant women with inflammatory bowel disease when clinically indicated.
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