Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006–2019

• Published in: Pharmacoepidemiology and drug safety 2024-08, Vol.33 (8), p.e5878-n/a
• Main Authors: Karlsson, Pär, Gembert, Karin, Esslinger, Suzan, Geldhof, Anja, Gissler, Mika, Leinonen, Maarit K., Otero‐Lobato, Marijo, Pedersen, Lars, Cesta, Carolyn E.
• Format: Article
• Language: English
• Subjects: Abnormalities, Drug-Induced - epidemiology; Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Biological products; Biopharmaceuticals; Cohort Studies; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - epidemiology; congenital anomalies; Congenital defects; Denmark - epidemiology; Female; Finland - epidemiology; golimumab; Humans; Infant; Infant, Newborn; Infants; infection; inflammatory bowel disease; Medicin och hälsovetenskap; Population studies; Pregnancy; Pregnancy Complications - drug therapy; Pregnancy Complications - epidemiology; Pregnancy Outcome - epidemiology; Prenatal experience; Prenatal Exposure Delayed Effects - chemically induced; Prenatal Exposure Delayed Effects - epidemiology; Rheumatic Diseases - drug therapy; Rheumatic Diseases - epidemiology; rheumatoid diseases; Sweden - epidemiology; tumor necrosis factor inhibitors; Ulcerative colitis; Young Adult
• ISSN: 1053-8569; 1099-1557; 1099-1557
• DOI: 10.1002/pds.5878

ABSTRACT Purpose 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. Methods 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. Results 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. Conclusions 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.