TY - JOUR
T1 - Birth outcomes in women who have taken adalimumab in pregnancy
T2 - A prospective cohort study
AU - OTIS Collaborative Research Group
AU - Chambers, Christina D.
AU - Johnson, Diana L.
AU - Xu, Ronghui
AU - Luo, Yunjun
AU - Lopez-Jimenez, Janina
AU - Adam, Margaret P.
AU - Braddock, Stephen R.
AU - Robinson, Luther K.
AU - Vaux, Keith
AU - Jones, Kenneth Lyons
AU - Quinn, D.
AU - Colon, C.
AU - Kao, K.
AU - Bertrand, K.
AU - Brochu, J.
AU - Lavigne, S.
AU - Conover, E.
AU - Cole, P.
AU - Roth, M.
AU - Dieter, K.
AU - Harris-Sagaribay, L.
AU - Wolfe, L.
AU - Carey, J.
AU - Romeo, A.
AU - Pupco, A.
AU - Ito, S.
AU - Bakhireva, L.
AU - Bautista, A.
N1 - Publisher Copyright: © 2019 Chambers et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85073622688
U2 - 10.1371/journal.pone.0223603
DO - 10.1371/journal.pone.0223603
M3 - Article
C2 - 31626646
SN - 1932-6203
VL - 14
JO - PLOS ONE
JF - PLOS ONE
IS - 10
M1 - e0223603
ER -