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Background: 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 five outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight (LBW) and infant infections) among pregnancies exposed versus unexposed in utero to biologics, thiopurines or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were utilized 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 (242), biologics (642) or both (227) versus unexposed (379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, LBW, and infections over the first year of life. Higher disease activity was associated with risk of 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).
Conclusions: Biologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or within 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
Uma Mahadevan,Millie D Long,Sunanda V Kane,Abhik Roy,Marla C Dubinsky,Bruce E Sands,Russell D Cohen,Christina D Chambers,William J Sandborn