Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

Disclosures: The study was supported by the Crohn’s & Colitis Foundation. Mahadevan reports serving as a consultant for AbbVie, Janssen, Pfizer, Prometheus Biosciences, Gilead, UCB and Takeda. Please see the study for all other authors’ relevant financial disclosures.
April 29, 2021
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IBD therapies do not increase adverse events in pregnancy

Disclosures: The study was supported by the Crohn’s & Colitis Foundation. Mahadevan reports serving as a consultant for AbbVie, Janssen, Pfizer, Prometheus Biosciences, Gilead, UCB and Takeda. Please see the study for all other authors’ relevant financial disclosures.
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Exposure to biologics, thiopurines or combination therapy for inflammatory bowel disease during pregnancy did not increase maternal or infant adverse events at birth or in 1-year of life, according to a study published in Gastroenterology.

“Until now, physicians couldn’t offer much guidance on which IBD medications are safe to take during pregnancy, leaving patients to wonder and worry how their IBD may impact their baby’s health and how the pregnancy would affect their IBD,” Uma Mahadevan, MD, told Healio Gastroenterology. “This groundbreaking study provides long-awaited, reassuring news for patients: they can keep taking biologics, thiopurines, or a combination of the two during pregnancy and breastfeeding without an increase in adverse effects. In fact, the greatest risk to pregnancy is disease activity which can lead to pregnancy loss, preterm birth and other complications. 

Exposure to biologics, thiopurines, or combination therapy for IBD during pregnancy do not increase adverse outcomes at birth or after 1-year of life. Source: Adobe Stock

From 2007 to 2019, Mahadevan, co-director of the UCSF Colitis and Crohn's Disease Center and Chair of the Crohn’s & Colitis Foundation Research Grants committee and colleagues enrolled 1,712 pregnant women with IBD from across the U.S. into their prospective, observational, multicenter study. There were 1,490 completed pregnancies and 1,431 live births. One-year outcomes were available for 1,010 infants. Primary analysis included comparison of congenital malformations, spontaneous abortions, prebirth, low birth weight and infant infections among pregnancies exposed and unexposed in utero to biologics, thiopurines or combination therapy.

Researchers used bivariate analyses followed by logistic regression models adjusted for relevant confounders to determine the independent effects of specific drug classes on outcomes of interest.

Investigators reported 242 pregnant women were exposed to thiopurines, 642 to biologics, 227 to both, and 379 were unexposed to either therapy. While study data did not show a link between an increase in adverse events in pregnancy, the researchers did note a correlation between disease activity and risk for spontaneous abortion (HR = 3.41; 95% CI, 1.51–7.69) and preterm birth with increased infant infection (OR = 1.73; 95% CI, 1.19–2.51).

“The low risk of the medications and the high risk of active disease supports patients remaining on appropriate medications to prevent flares,” Mahadevan said. “These outcomes build on the Crohn’s & Colitis Foundation’s mission to improve patient quality of life through innovative, patient-centered research.”