LA JOLLA, CA – Vedolizumab (sold under the trade name Entyvio®) is a medication that is used to treat Crohn’s disease and ulcerative colitis, which are two forms of inflammatory bowel disease (IBD). For women who became pregnant while taking vedolizumab, there are limited data on whether this medication could affect the pregnancy and the developing baby. Our study sought to examine this question by evaluating the safety/risk of vedolizumab use in pregnant women who were participating in MotherToBaby Pregnancy Studies.
What did we study? From 2015 to 2022, we enrolled 275 pregnant women in the United States and Canada; 99 of the women had IBD and reported taking vedolizumab sometime during their pregnancy, 76 women had IBD but were being treated with other biologic medications, and the remaining 100 women did not have IBD and were not exposed to vedolizumab or other biologic medications.
We interviewed the mothers up to three times during their pregnancy and once at the end of their pregnancies. We also collected information from the medical records of both mom and baby. Finally, a subset of the babies was examined by one of our study doctors. We then compared the three groups of women by looking at several pregnancy and birth outcomes, including pregnancy loss, preterm birth, and birth defects.
What did we find? We found no meaningful differences in the rates of pregnancy loss, preterm birth, or birth defects between the groups. There were also no meaningful differences between the groups on infant growth measures at birth and at 1 year of age.
What’s the takeaway? Taking vedolizumab in pregnancy did not increase the chance of birth defects or other adverse pregnancy outcomes. Our study provides additional reassuring evidence for women with IBD who take vedolizumab during pregnancy.
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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org.
