Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006-2019.
Humans
Female
Pregnancy
Sweden
/ epidemiology
Antibodies, Monoclonal
/ adverse effects
Infant, Newborn
Pregnancy Outcome
/ epidemiology
Adult
Prenatal Exposure Delayed Effects
/ epidemiology
Finland
/ epidemiology
Infant
Cohort Studies
Rheumatic Diseases
/ drug therapy
Denmark
/ epidemiology
Colitis, Ulcerative
/ drug therapy
Pregnancy Complications
/ drug therapy
Abnormalities, Drug-Induced
/ epidemiology
Young Adult
congenital anomalies
golimumab
infection
inflammatory bowel disease
pregnancy
rheumatoid diseases
tumor necrosis factor inhibitors
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
Aug 2024
Aug 2024
Historique:
revised:
20
06
2024
received:
05
04
2024
accepted:
03
07
2024
medline:
2
8
2024
pubmed:
2
8
2024
entrez:
1
8
2024
Statut:
ppublish
Résumé
To present the main findings of a post-authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in a real-world setting. This observational population-based cohort study included data from pregnancies ending in 2006-2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases or ulcerative colitis diagnoses were identified. Based on prescription fills from 90 days prior to pregnancy until delivery, infants were assigned to one of the four drug-exposure cohorts: golimumab, other anti-TNF biologics, other biologics, and nonbiologic systemic therapy, and the general population. Prevalence of adverse pregnancy outcomes, mortality, diagnoses of major congenital anomalies (MCA), and inpatient infections in the infants' first year of life were assessed. Odds ratios and 95% CIs were calculated for MCA and infection. Among 134 infants in the golimumab cohort, none were stillborn or died in the first year of life. MCA were diagnosed in 4.5% of the infants in the golimumab cohort, versus 6.8%, 10.9%, 5.5%, and 4.6% in the other anti-TNF biologics, other biologics, nonbiologic systemic therapy and general population cohorts, respectively. Inpatient infections were diagnosed in 11% of golimumab-exposed infants, compared with 9%-11% of infants in the other cohorts. Unadjusted and selected adjusted comparisons showed no association between prenatal golimumab exposure and MCA or infection compared with the other exposure cohorts or general population. The number of infants with prenatal golimumab exposure was low, but results are reassuringly consistent with the evidence available for other anti-TNF biologics. Continued monitoring is needed.
Substances chimiques
golimumab
91X1KLU43E
Antibodies, Monoclonal
0
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e5878Subventions
Organisme : Janssen Biologics BV
Informations de copyright
© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
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