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

Autoři: Christina D. Chambers aff001;  Diana L. Johnson aff001;  Ronghui Xu aff002;  Yunjun Luo aff001;  Janina Lopez-Jimenez aff001;  Margaret P. Adam aff004;  Stephen R. Braddock aff005;  Luther K. Robinson aff006;  Keith Vaux aff001;  Kenneth Lyons Jones aff0010
Působiště autorů: Department of Pediatrics, University of California San Diego, La Jolla, CA, United States of America aff001;  Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States of America aff002;  Department of Mathematics, University of California San Diego, La Jolla, CA, United States of America aff003;  Department of Pediatrics, University of Washington, Seattle, WA, United States of America aff004;  Deparment of Pediatrics, Saint Louis University, St. Louis, MO, United States of America aff005;  Department of Pediatrics, State University of New York at Buffalo, Buffalo, NY, United States of America aff006
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223603



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.


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.

Klíčová slova:

Birth defects – Crohn's disease – Infants – Opportunistic infections – Pregnancy – Preterm birth – Rheumatoid arthritis – Women's health


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2019 Číslo 10