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

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.

Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis

“…The material included in this quantitative evaluation is shown in Supplementary Figure 1, and Supplementary Tables 1 and 3). Of 116 unique publications identified in this systematic review, including 7941 pregnancies among women with IBD, 5 studies were excluded from the meta-analysis because of a mix of patients with IBD and other chronic inflammatory disorders, including rheumatoid arthritis, [31][32][33][34][35] and 1 other study was omitted because not all participants received a biologic agent. 36 Moreover, all studies with fewer than 10 individuals were excluded from meta-analyses because they often are highly selected (based on a positive or negative findings) and therefore may not be representative of pregnant women with IBD exposed to biologics (Supplementary Table 3).…”

Biologic Treatment Algorithms for Moderate-to-Severe Psoriasis with Comorbid Conditions and Special Populations: A Review

“…The Organization of Teratology Information Specialists (OTIS) analyzed adalimumab in the first trimester of pregnancy in patients with autoimmune conditions and reported a rate of major birth defects of 10% in adalimumab-exposed patients compared with 7.5% in the diseased but unexposed cohort [ 160 ]. OTIS did not report significant increases in structural defects, pregnancy complications, or fetal and infant adverse health outcomes, although the risk of preterm delivery increased [ 160 ]. FDA information showed active placental transfer of adalimumab during the third trimester and a presence in infants for up to 3 months after birth.…”

Gestational Diabetes Mellitus and Maternal Immune Dysregulation: What We Know So Far

“…A prospective cohort study has concluded that adalimumab is a safe treatment in pregnancy, where clinical benefits of treatment exceed the clinical risks in untreated pregnancies. This study found no increased risk of adverse maternal or foetal outcomes during adalimumab administration [ 178 ].…”