Birth Outcomes in Women Who Have Taken Vedolizumab in Pregnancy: Results From the Vedolizumab Pregnancy Exposure Registry

Christina D Chambers; Diana L Johnson; Yunjun Luo; Ronghui Xu; Margaret P Adam; Stephen R Braddock; Kenneth Lyons Jones; OTIS Collaborative Research Group

doi:10.14309/ajg.0000000000003593

Birth Outcomes in Women Who Have Taken Vedolizumab in Pregnancy: Results From the Vedolizumab Pregnancy Exposure Registry

Am J Gastroenterol. 2025 Jun 11. doi: 10.14309/ajg.0000000000003593. Online ahead of print.

Authors

Christina D Chambers^{1

2}, Diana L Johnson¹, Yunjun Luo¹, Ronghui Xu^{2

3}, Margaret P Adam⁴, Stephen R Braddock⁵, Kenneth Lyons Jones¹; OTIS Collaborative Research Group

Collaborators

OTIS Collaborative Research Group:
C Stallman, K Perrotta, A Messer, S Voyer Lavigne, C Senechal, E Conover, P Cole, L Harris-Sagaribay, S G Običan, R Müller, L Wolfe, S Sherman, K Richardson, M Ashfaq, A Romeo, C González, C Coles, H Hazard, R Miller

Affiliations

¹ Department of Pediatrics, University of California San Diego, San Diego, California, USA.
² Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, San Diego, California, USA.
³ Department of Mathematics, University of California San Diego, San Diego, California, USA.
⁴ Department of Pediatrics, University of Washington, Seattle, Washington, USA.
⁵ Deparment of Pediatrics, Saint Louis University, St. Louis, Missouri, USA .

PMID: 40498121
DOI: 10.14309/ajg.0000000000003593

Abstract

Objectives: There are limited data on the safety of vedolizumab in pregnancy for the treatment of Crohn's disease or ulcerative colitis. Between 2015 and 2022, the Organization of Teratology Information Specialists conducted a prospective, observational pregnancy registry study with 275 pregnant women residing in the United States or Canada.

Methods: Women were enrolled in 1 of 3 cohorts: vedolizumab-exposed (N = 99); disease-matched unexposed to vedolizumab, but treated with another biologic in pregnancy (N = 76); or unexposed with no chronic health conditions (N = 100). Women and their infants were followed up to 1 year postpartum with maternal interviews, questionnaires, medical records abstraction, and a subset of infants who received a physical examination. Study outcomes were major structural birth defects, minor birth defects, pregnancy loss, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, malignancies, and developmental milestones.

Results: In the overall registry, 17 of 275 pregnancies (6.2%) were lost to follow-up. Among pregnancies ending in at least 1 live born infant, 7 of 94 (7.4%) in the vedolizumab-exposed cohort compared with 4 of 71 (5.6%) in the disease-matched cohort had a major birth defect (adjusted risk ratio 1.07, 95% confidence interval [CI] 0.33, 3.52). Compared with the disease-matched cohort, women in the vedolizumab-exposed group were not statistically significantly more likely to experience spontaneous abortion (adjusted hazard ratio 1.01, 95% CI 0.17, 5.89). Women in the vedolizumab-exposed group were slightly but not significantly more likely to deliver preterm (adjusted hazard ratio 1.58, 95% CI 0.65, 3.82).

Conclusions: No significant increased risks were noted with vedolizumab exposure for any of the other study outcomes. These data add reassuring evidence in support of the safety of vedolizumab in pregnancy.

Keywords: Crohn's disease; birth defects; pregnancy; registry; safety; ulcerative colitis; vedolizumab.

Grants and funding

Takeda Pharmaceutical Company