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  1. Home
  3. Birth Outcomes In Women Who Have Taken Vedolizumab In Pregnancy: Results From The Vedolizumab Pregnancy Exposure Registry
  1. Home
  3. Birth Outcomes In Women Who Have Taken Vedolizumab In Pregnancy: Results From The Vedolizumab Pregnancy Exposure Registry

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Birth outcomes in women who have taken vedolizumab in pregnancy: results from the Vedolizumab Pregnancy Exposure

Christina D Chambers1,2, Diana L Johnson1, Yunjun Luo1

  • 1Department of Pediatrics, University of California San Diego, La Jolla, CA.

The American Journal of Gastroenterology
|June 11, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

This study found vedolizumab (a biologic therapy) is a safe treatment option during pregnancy for Crohn's disease and ulcerative colitis. No significant risks were observed for major birth defects or other adverse pregnancy outcomes.

Keywords:
Crohn’s Diseasebirth defectspregnancyregistrysafetyulcerative colitisvedolizumab

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Area of Science:

  • Gastroenterology
  • Immunology
  • Reproductive Medicine

Background:

  • Limited data exists on vedolizumab safety in pregnancy for inflammatory bowel disease (IBD).
  • Vedolizumab is a biologic therapy used for Crohn's disease and ulcerative colitis.
  • Pregnancy registries are crucial for assessing medication safety during gestation.

Purpose of the Study:

  • To evaluate the safety of vedolizumab exposure during pregnancy in women with IBD.
  • To compare pregnancy and infant outcomes between vedolizumab-exposed and unexposed cohorts.
  • To provide evidence-based information for clinicians and patients regarding vedolizumab use in pregnancy.

Main Methods:

  • Prospective, observational pregnancy registry study (2015-2022) involving 275 pregnant women.
  • Three cohorts: vedolizumab-exposed (N=99), disease-matched biologic-exposed (N=76), and unexposed (N=100).
  • Follow-up to one year postpartum assessing major/minor birth defects, pregnancy loss, preterm delivery, growth, infections, malignancies, and development.

Main Results:

  • No statistically significant increased risk of major birth defects (aRR 1.07) or spontaneous abortion (aHR 1.01) with vedolizumab exposure.
  • Slight, non-significant increase in preterm delivery (aHR 1.58) observed in the vedolizumab group.
  • No significant increased risks identified for other study outcomes, including postnatal growth and infections.

Conclusions:

  • Vedolizumab exposure during pregnancy appears to be safe for treating Crohn's disease and ulcerative colitis.
  • The study provides reassuring evidence supporting the use of vedolizumab in pregnant IBD patients.
  • Further research may continue to monitor long-term outcomes, but current data is favorable.