Exposure to golimumab during pregnancy: Results from the Company's global safety database.
Pregnancy
Female
Humans
Databases, Factual
Antibodies, Monoclonal
/ adverse effects
Adult
Pregnancy Outcome
/ epidemiology
Abnormalities, Drug-Induced
/ epidemiology
Pregnancy Complications
/ drug therapy
Abortion, Spontaneous
/ epidemiology
Antirheumatic Agents
/ adverse effects
Young Adult
Prospective Studies
Live Birth
/ epidemiology
abortion
congenital anomalies
golimumab
live birth
pharmacovigilance
pregnancy
tumor necrosis factor inhibitors
Journal
Pharmacology research & perspectives
ISSN: 2052-1707
Titre abrégé: Pharmacol Res Perspect
Pays: United States
ID NLM: 101626369
Informations de publication
Date de publication:
Aug 2024
Aug 2024
Historique:
revised:
14
06
2024
received:
25
04
2024
accepted:
20
06
2024
medline:
6
7
2024
pubmed:
6
7
2024
entrez:
6
7
2024
Statut:
ppublish
Résumé
Data on the use of golimumab (GLM) during pregnancy are limited. This study evaluated pregnancy outcomes in women treated with GLM during pregnancy. Cumulative data on GLM-exposed pregnancies from the Company's global safety database (GSD) are summarized. Cases were medically confirmed maternal exposures to GLM during pregnancy or within 3 months prior to conception with a reported pregnancy outcome. Pregnancy outcomes (e.g., live births) and congenital anomalies in prospectively reported cases (i.e., pregnancy outcome not known when first reported to the company) are presented in a descriptive manner. As of May 31, 2022, 261 prospectively reported pregnancies exposed to GLM were reported in the GSD: 214 (82.0%) live births (including six sets of twins), 31 (11.9%) spontaneous abortions (including one set of twins), 13 (5.0%) induced/elective abortions, 2 (0.8%) reported intrauterine death/still birth, and 1 (0.4%) fetal adverse event in an ongoing pregnancy. The majority of pregnancies had exposure to GLM at least in the first trimester of pregnancy. In total, seven congenital anomalies (7/261; 2.7%) were reported. Of these seven congenital anomalies, five were considered major according to EUROCAT classification version 1.4. Among the five prospectively reported congenital anomalies noted in live births (5/214; 2.3%), four were classified as major (4/214; 1.8%). The rates of adverse pregnancy outcomes and major congenital anomalies in prospectively reported pregnancy cases with exposure to GLM in the Company's GSD were consistent with published background rates for the general population.
Substances chimiques
golimumab
91X1KLU43E
Antibodies, Monoclonal
0
Antirheumatic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1240Subventions
Organisme : Janssen Biologics BV, Medical Affairs
Informations de copyright
© 2024 Johnson & Johnson Innovative Medicine. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.
Références
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