Centre for Pharmacoepidemiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
Cilag GmbH International, Medical Affairs, Zug, Switzerland.
Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5878. doi: 10.1002/pds.5878.
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.
在真实环境中，呈现一项评估产前戈利木单抗暴露后妊娠和婴儿结局的上市后安全性研究的主要发现。
这项观察性基于人群的队列研究纳入了 2006 年至 2018 年（芬兰）或 2019 年（丹麦、瑞典）妊娠结局的患者数据。鉴定出患有风湿性疾病或溃疡性结肠炎诊断的婴儿。根据从妊娠前 90 天至分娩期间的处方填写情况，将婴儿分配至四个药物暴露队列之一：戈利木单抗、其他抗 TNF 生物制剂、其他生物制剂和非生物制剂系统性治疗以及普通人群。评估婴儿出生后第一年的不良妊娠结局、死亡率、主要先天畸形（MCA）诊断和住院感染的发生率。计算了 MCA 和感染的比值比（OR）和 95%置信区间（CI）。
在戈利木单抗队列的 134 名婴儿中，无死胎或婴儿在出生后第一年死亡。戈利木单抗队列中婴儿的 MCA 诊断率为 4.5%，而其他抗 TNF 生物制剂、其他生物制剂、非生物制剂系统性治疗和普通人群队列中分别为 6.8%、10.9%、5.5%和 4.6%。戈利木单抗暴露婴儿的住院感染诊断率为 11%，而其他队列中婴儿的感染诊断率为 9%-11%。未调整和选定调整的比较均显示，与其他暴露队列或普通人群相比，产前戈利木单抗暴露与 MCA 或感染之间无关联。
产前戈利木单抗暴露的婴儿数量较少，但结果与其他抗 TNF 生物制剂的现有证据一致，令人放心。需要持续监测。
