November 02, 2025

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Biologic Use Safe In Pregnant Women With Inflammatory Bowel Disease, Finds Study

Denmark: The use of biologics appears to be safe in pregnant women with inflammatory bowel disease (IBD), suggests a recent study in the journal Clinical Gastroenterology and Hepatology. The adverse pregnancy outcomes (such as early pregnancy loss, stillbirth, preterm birth, low birth weight, and congenital malformations) were comparable in women using biologics versus the general population.
Biologics (anti-TNF agents, anti-integrins, and anti cytokines) are routinely used in pregnant women with IBD but there is a lack of large-scale data reporting adverse pregnancy outcomes in those using biologics. Ole Haagen Nielsen, Herlev Hospital, Univ. of Copenhagen, Denmark, and colleagues sought to estimate the prevalence of adverse pregnancy outcomes in IBD women on biologic therapies.
The researchers searched the online databases from inception to June 2020 for studies that estimated the prevalence of adverse pregnancy outcomes in IBD in women using biologics. Prevalence and relative risk (RR) were pooled using a random-effects model.
The meta-analysis included forty-eight studies comprising of 6963 patients.
Key findings of the study include:
Biologic therapy in IBD pregnancies was associated with a pooled prevalence of 8% for early pregnancy loss, 9% preterm birth, 0% stillbirth, 8% low birth weight, and 1% congenital malformations.
These rates are comparable to those published in the general population.
In subgroup analyses of a small number of studies, the prevalence of early pregnancy loss and preterm birth were higher in vedolizumab versus anti-TNF users.
Meta-regression did not reveal an association of disease activity or concomitant thiopurine on adverse outcomes.
Continued TNF inhibitor use during the third trimester was not associated with risk of preterm birth (RR 1.41), low birth weight (RR 1.32), or congenital malformations (RR 1.28).
"Adverse pregnancy outcomes among pregnant IBD women with biologic use are comparable with that of the general population," concluded the authors.
"Biologics for Inflammatory Bowel Disease and their Safety in Pregnancy: A Systematic Review and Meta-analysis," is published in the journal Clinical Gastroenterology and Hepatology.
DOI: https://www.sciencedirect.com/science/article/pii/S1542356520312817

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