Adalimumab Treatment for Inflammatory Bowel Disease During Late Pregnancy Poses Low Risk for Child

Midsection of pregnant Black woman holding belly
Researchers examined the effects on mother and child of discontinuing adalimumab early and late during pregnancy.

Receiving treatment with adalimumab for inflammatory bowel disease (IBD) into late pregnancy presents a low risk for unborn children, but early discontinuation increases risk for flaring and premature deliveries, according to study results published in Gastro Hep Advances.

Researchers conducted a retrospective analysis using data from IBM MarketScan (2010-2017) on pregnant patients and their unborn children exposed to adalimumab during gestation. A total of 497 patients and their children were included in the study. Researchers compared congenital malformations, milestones achievements, and respiratory infections among children from mothers in 2 groups: late adalimumab (therapy continued until ≤90 days before delivery) and early adalimumab (therapy discontinued >90 days before delivery). The risk for flaring in mothers was also assessed in the early group. Multivariable logistic regression examined the effect of adalimumab injection timing on disease activity.

Both the early and late groups showed no significant differences in congenital malformations, growth abnormalities, or developmental delays. Respiratory infection rate neither increased with late adalimumab use in pregnancy (P =.389), nor were there differences in premature birth (P =.692), cesarean delivery (P =.208), stillbirth (P =.364), or intrauterine growth retardation (P =.361).

Flaring was more common among mothers in the early adalimumab discontinuation group than in the late group (3.6% vs 17.8%, respectively; P <.001), and adalimumab discontinuation was the sole predictor of third trimester flaring. Those who experienced flaring during pregnancy vs who did not were significantly more likely to experience premature delivery (6/29 vs. 31/491, respectively; P =.003).

One study limitation was the inability to assess disease activity before and during pregnancy.

“Our results should reassure mothers and providers of the low risk [for] [adalimumab] therapy in the third trimester of pregnancy,” the study authors wrote. “We showed no child health benefit associated with early discontinuation of [adalimumab] in pregnancy, at least in the first year of life. By contrast, continuing [adalimumab] maintained disease remission and minimized the risk of flaring.”


Truta B, Canner J, Fang S, Efron J, Safar B. Outcomes of continuation versus discontinuation of adalimumab therapy during third trimester of pregnancy in inflammatory bowel disease. Gastro Hep Advances. Published online May 16, 2022. doi:10.1016/j.gastha.2022.04.009