Douglas K. Rex, MD reviewing Julsgaard M et al. Gastroenterology 2016 Apr 7.

Infection risk through age 1 was nearly three times higher among infants whose mothers also needed thiopurines for IBD treatment during pregnancy.

In utero exposure to anti–tumor necrosis factor (TNF) agents has not been associated with adverse neonatal health outcomes, but few studies have examined drug clearance and health effects during infancy.

In a prospective study, investigators measured maternal and fetal (via cord blood) levels of infliximab and adalimumab at the time of delivery in 80 pregnant women with inflammatory bowel disease (IBD) and continued to measure drug concentrations in infants with detectable levels at birth.

Cord blood levels at delivery were 21% higher than maternal blood levels for adalimumab and 97% higher for infliximab. The time between last drug administration to the mother and delivery was the only predictor of drug concentration in cord blood. Specifically, fetal blood levels were not related to disease activity in the mother.

The mean time to drug clearance in the infants was 4.0 months and 7.3 months for adalimumab and infliximab, respectively (P<0.0001). Infection incidence through age 1 year was 4 (5%) for bacterial infections, all of which were successfully treated with antibiotics, and 16 (20%) for viral infections, which were benign. The risk for infection was 2.7 times higher among infants whose mothers took combination therapy (anti-TNF plus thiopurine) during pregnancy compared with anti-TNF alone.

Citation(s):

Julsgaard M et al. Concentrations of adalimumab and infliximab in mothers and newborns, and effects on infection. Gastroenterology 2016 Apr 7; [e-pub].

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