Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease

Gastroenterology. 2021 Mar;160(4):1131-1139. doi: 10.1053/j.gastro.2020.11.038.Epub 2020 Nov 21.

Uma Mahadevan 1, Millie D Long 2, Sunanda V Kane 3, Abhik Roy 4, Marla C Dubinsky 5, Bruce E Sands 5, Russell D Cohen 6, Christina D Chambers 7, William J Sandborn 8, Crohn’s Colitis Foundation Clinical Research Alliance


Author information

  • 1Division of Gastroenterology and Hepatology, University of California San Francisco, San Francisco, California. Electronic address: uma.mahadevan@ucsf.edu.
  • 2Division of Gastroenterology and Hepatology, Data Management Center, University of North Carolina, Chapel Hill, North Carolina.
  • 3Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
  • 4Division of Gastroenterology, Kaiser Permanente, San Leandro, California.
  • 5Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
  • 6Section of Gastroenterology, Hepatology and Nutrition, University of Chicago, Chicago, Illinois.
  • 7Department of Pediatrics, University of California San Diego, La Jolla, California.
  • 8Division of Gastroenterology and Hepatology, University of California San Diego, La Jolla, California.


Background & aims: Pregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child.

Methods: Between 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States. The primary analysis was a comparison of 5 outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infant infections) among pregnancies exposed vs unexposed in utero to biologics, thiopurines, or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were used to determine the independent effects of specific drug classes on outcomes of interest.

Results: Among 1490 completed pregnancies, there were 1431 live births. One-year infant outcomes were available in 1010. Exposure was to thiopurines (n = 242), biologics (n = 642), or both (n = 227) vs unexposed (n = 379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infections during the first year of life. Higher disease activity was associated with risk of spontaneous abortion (hazard ratio, 3.41; 95% confidence interval, 1.51-7.69) and preterm birth with increased infant infection (odds ratio, 1.73; 95% confidence interval, 1.19-2.51).

Conclusions: Biologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or in the first year of life. Therapy with these agents can be continued throughout pregnancy in women with IBD to maintain disease control and reduce pregnancy-related adverse events. ClinicalTrials.gov, Number: NCT00904878.

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