For pregnant women with inflammatory bowel disease (IBD), the risk of adverse pregnancy outcomes associated with biologic agent use is comparable to that of the general population, according to a recent systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.

The study aimed to determine the prevalence of adverse pregnancy outcomes associated with biologic use in women with IBD. Major databases were searched from inception to June 2020 to obtain studies that reported adverse pregnancy outcomes in IBD patients taking anti-tumor necrosis factor (TNF), anti-integrin, and anti-cytokine agents. A random effects model was used to pool prevalence and relative risk (RR).

A total of 48 studies with 6963 patients were included in the meta-analysis. “Biologic therapy in IBD pregnancies was associated with a pooled prevalence of 8% (95% CI, 6-10%, I2= 87.4%) for early pregnancy loss, 9% (95% CI, 7-11%, I2=89.9%) preterm birth, 0% (95% CI, 0-0%, I2=0%) still birth, 8% (95% CI, 5-10%, I2=87.0%) low birth weight, and 1% (95% CI, 1-2%, I2=78.3%) congenital malformations,” the study authors reported. They added, “These rates are comparable to those published in the general population.”

Subgroup analyses did reveal an increased incidence of early pregnancy loss and preterm birth among patients who received vedolizumab compared with those who received anti-TNF agents, however, the quality of the evidence was considered low. The study authors also reported that no association between disease activity or concomitant thiopurine and adverse outcomes was observed using meta-regression.

Additionally, findings of the study revealed that TNF inhibitor use during the third trimester of pregnancy did not affect the risk of preterm birth (RR, 1.41; 95% CI, 0.77-2.60; I2, 0%), low birth weight (RR, 1.32; 95% CI, 0.80-2.18; I2, 0%), or congenital malformations (RR, 1.28; 95% CI, 0.47-3.49; I2, 0%).

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“The present study suggests that the prevalence of adverse pregnancy outcomes among IBD women on biologic therapy is relatively low and no greater than observed in the general population,” the study authors concluded. They added, ” Overall, our findings highlight that the benefits of biologics during pregnancy in women with IBD outweigh the risks with regards to adverse pregnancy outcomes.”


Nielsen OH, Gubatan JM, Juhl CB, Streett SE, Maxwell C, Biologics for inflammatory bowel disease and their safety in pregnancy: a systematic review and meta-analysis. Clinical Gastroenterology and Hepatology (2020).