Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study

PLoS One. 2019 Oct 18;14(10):e0223603. doi: 10.1371/journal.pone.0223603. eCollection 2019.


Background: Information is needed on the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases.

Methods and findings: Between 2004 and 2016, the Organization of Teratology Information Specialists Research Center at the University of California San Diego conducted a prospective controlled observational cohort study in 602 pregnant women who had or had not taken adalimumab. Women in the adalimumab-exposed cohort had received at least one dose of the drug in the first trimester for the treatment of rheumatoid arthritis or Crohn's Disease (N = 257). Women in the disease comparison cohort had not used adalimumab in pregnancy (N = 120). Women in the healthy comparison cohort had no rheumatic or inflammatory bowel diseases (N = 225). Women and their infants were followed to one year postpartum with maternal interviews, medical records abstraction, and physical examinations. Study outcomes were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, pre and post-natal growth deficiency, serious or opportunistic infections and malignancies. 42/602 (7.0%) of pregnancies were lost-to-follow-up. 22/221 (10.0%) in the adalimumab-exposed cohort had a live born infant with a major birth defect compared to 8/106 (7.5%) in the diseased unexposed cohort (adjusted odds ratio 1.10, 95% confidence interval [CI] 0.45 to 2.73). Women in the adalimumab-exposed cohort were more likely to deliver preterm compared to the healthy cohort (adjusted hazard ratio [aHR] 2.59, 95% CI 1.22 to 5.50), but not compared to the diseased unexposed cohort (aHR 0.82, 95% CI 0.66 to 7.20). No significant increased risks were noted with adalimumab exposure for any other study outcomes.

Conclusions: Adalimumab exposure in pregnancy compared to diseased unexposed pregnancies was not associated with an increased risk for any of the adverse outcomes examined. Women with rheumatoid arthritis or Crohn's Disease were at increased risk of preterm delivery, irrespective of adalimumab exposure.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / adverse effects*
  • Adalimumab / therapeutic use
  • Adult
  • Antirheumatic Agents / adverse effects*
  • Antirheumatic Agents / therapeutic use
  • Congenital Abnormalities / epidemiology
  • Congenital Abnormalities / etiology
  • Female
  • Humans
  • Live Birth
  • Maternal Exposure / adverse effects*
  • Middle Aged
  • Odds Ratio
  • Pregnancy
  • Pregnancy Complications / drug therapy
  • Pregnancy Complications / epidemiology
  • Pregnancy Outcome*
  • Risk Factors
  • Young Adult


  • Antirheumatic Agents
  • Adalimumab

Grant support

KLJ, CC and RX received the funding. Study funded partly by AbbVie. Following the guidelines on good publication practice, the funding body had no involvement in the data collection or analysis, the preparation of the manuscript or the decision to submit the paper for publication.