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

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

Author information

1
Department of Pediatrics, University of California San Diego, La Jolla, CA, United States of America.
2
Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States of America.
3
Department of Mathematics, University of California San Diego, La Jolla, CA, United States of America.
4
Department of Pediatrics, University of Washington, Seattle, WA, United States of America.
5
Deparment of Pediatrics, Saint Louis University, St. Louis, MO, United States of America.
6
Department of Pediatrics, State University of New York at Buffalo, Buffalo, NY, United States of America.

Abstract

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.

Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: Drs. Chambers, Jones and Xu received research funding from AbbVie, Amgen, Astra Zeneca, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Regeneron, Roche Genentech, Sanofi Genzyme, Seqirus, Takeda, Teva, and UCB during the conduct of the study.

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