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Adalimumab and Pregnancy Outcomes

A prospective study of birth outcomes to mothers exposed to adalimumab (ADA) between 2004 and 2016 was conducted by Organization of Teratology Information Specialists (OTIS) Research Center at the University of California San Diego, and showed that ADA exposure was not associated with an increased risk for any of the adverse outcomes examined.

The study included 257 women who received ADA in the first trimester for the treatment of rheumatoid arthritis (RA) or Crohn's Disease (CD).  Their outcomes were compared to RA and CD not exposed to adalimumab in pregnancy (N = 120) and a healthy comparison cohort had no rheumatic or inflammatory bowel diseases (N = 225).

Major outcomes included:

  • Major birth defects: ADA 10% vs RA/CD 7.5% (not significant)
  • Preterm delivery : Higher in ADA compared to healthy cohort (adjusted HR 2.59, 95% CI 1.22 to 5.50), but not when compared to the diseased unexposed cohort (aHR 0.82, 95% CI 0.66 to 7.20).

RA and CD women were at increased risk of preterm delivery, irrespective of adalimumab exposure.

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

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