Risk for birth defects not increased with adalimumab

(HealthDay)—Adalimumab exposure in pregnancy does not increase the risk for birth defects, according to a study published online Oct. 18 in PLOS ONE.

Christina D. Chambers, from the University of California San Diego in La Jolla, and colleagues assessed the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases. The analysis included 602 pregnant women: 257 adalimumab-exposed in the first trimester for the treatment of rheumatoid arthritis or Crohn disease; 120 women in the disease comparison cohort who had not used adalimumab in pregnancy; and 225 women in the healthy comparison cohort with no rheumatic or inflammatory bowel diseases. Patients were followed for one year postpartum.

The researchers found that 10.0 percent of women in the adalimumab-exposed cohort had a live-born infant with a major birth defect compared with 7.5 percent in the disease/unexposed cohort (adjusted odds ratio, 1.10; 95 percent confidence interval, 0.45 to 2.73). Preterm delivery was more likely among women in the adalimumab-exposed cohort versus the healthy cohort (adjusted hazard ratio, 2.59; 95 percent confidence interval, 1.22 to 5.50), but not compared with the disease/unexposed cohort (adjusted hazard ratio, 0.82; 95 percent confidence interval, 0.66 to 7.20).

"We found no evidence of an increased risk of major structural birth defects as well as a wide range of other pregnancy outcomes attributable to prenatal exposure to adalimumab," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including AbbVie, which manufactures adalimumab and partially funded the study.

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