Background and Aims
Adalimumab (ADA) transport across the placenta increases with gestational age advances.
We evaluated child–mother health outcomes related to the timing of the last ADA dose
before delivery.
Methods
Using IBM MarketScan data, we collected records for all children exposed to ADA during
intrauterine life. We compared milestone achievements, congenital malformations, and
respiratory infections rates in children from mothers of 2 groups: (1) a late ADA
group, which continued therapy until 90 days or fewer before delivery; and (2) an
early ADA group, which discontinued therapy more than 90 days before delivery. We
also assessed the risk of flaring for mothers in the early group.
Results
There were no significant differences in growth (P = .48), developmental delays (P = .25), or congenital malformations (P = .61) in the 427 children of the late group vs 70 children of early ADA group. Continuing
ADA late in pregnancy did not increase the respiratory infection rate (P = .38). No differences occurred between groups in cesarean and premature delivery,
intrauterine growth retardation, and stillbirths. ADA discontinuation was the only
predictor of flaring in the third trimester of pregnancy (odds ratio = 6.04, 95% confidence
interval 2.66–13.7). In the late group, mothers’ risk of flaring decreased (16/447
vs 13/73, P < .001). Mothers with active disease were more likely to deliver prematurely vs mothers
with quiet disease (6/29 vs 31/491, P = .003).
Conclusion
Continuation of ADA in pregnancy close to delivery is of low risk for children. Early
discontinuation, however, increases the risk of flaring in mothers and the likelihood
of premature deliveries.
Keywords
Abbreviations used in this paper:
AGA (American Gastroenterological Association), CD (Crohn’s disease), IBD (inflammatory bowel disease), ICD (International Classification of Disease), IFX (infliximab), TNF (tumor necrosis factor)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: May 16, 2022
Accepted:
April 12,
2022
Received:
November 15,
2021
Footnotes
Conflicts of Interest: The authors disclose no conflicts.
Funding: The authors report no funding.
Ethical Statement: The corresponding author, on behalf of all authors, jointly and severally, certifies that their institution has approved the protocol for any investigation involving humans or animals and that all experimentation was conducted in conformity with ethical and humane principles of research.
Data Transparency Statement: Data, analytic methods, and study materials will be available to other researchers per request.
Writing Assistance: Johns Hopkins University Editorial Assistance Service Initiative.
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