Abstract
BackgroundInformation is needed on the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases.Methods and findingsBetween 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.ConclusionsAdalimumab 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.
Highlights
Anti-tumor necrosis factor alpha therapies have been available for the treatment of various chronic inflammatory diseases for over 20 years
Adalimumab exposure in pregnancy compared to diseased unexposed pregnancies was not associated with an increased risk for any of the adverse outcomes examined
All women in the adalimumab-exposed cohort were exposed for some period of time in the first trimester, 65% of the sample used the medication in all three trimesters (Table 1)
Summary
Anti-tumor necrosis factor alpha (anti-TNF-α) therapies have been available for the treatment of various chronic inflammatory diseases for over 20 years Many of these diseases are prevalent in women of child-bearing age. For this reason, evaluation of the safety of anti-TNF-α therapies used in pregnancy is needed. Adalimumab is a fully humanized monoclonal antibody with a high molecular weight and is expected to require active transport in order to cross the human placenta For this reason, it is thought that potential exposure of the embryo via placental transfer is limited earlier in pregnancy, while transfer to the fetus later in pregnancy has been documented [1]. Information is needed on the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases
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