目的:介绍一项授权后安全性研究的主要发现,该研究在真实世界中评估产前戈利木单抗暴露后的妊娠和婴儿结局。
方法:这项基于人群的观察性队列研究包括了2006-2018年(芬兰)或2019年(丹麦,瑞典)。确定了患有风湿性疾病或溃疡性结肠炎的女性所生的婴儿。根据怀孕前90天至分娩前的处方配药,婴儿被分配到四个药物暴露队列之一:戈利木单抗,其他抗TNF生物制剂,其他生物制品,和非生物系统治疗,和普通民众。不良妊娠结局的患病率,死亡率,主要先天性异常(MCA)的诊断,并评估了婴儿出生后第一年的住院感染情况。计算MCA和感染的几率和95%CI。
结果:在戈利木单抗队列中的134名婴儿中,没有人在出生后的第一年就死产或死亡。在戈利木单抗队列中,4.5%的婴儿被诊断出MCA,与6.8%相比,10.9%,5.5%,其他抗TNF生物制剂中的4.6%,其他生物制品,非生物系统治疗和普通人群队列,分别。11%的戈利木单抗暴露婴儿被诊断出住院感染,与其他队列中9%-11%的婴儿相比。与其他暴露队列或普通人群相比,未经调整和选择的调整比较显示,产前戈利木单抗暴露与MCA或感染之间没有关联。
结论:产前戈利木单抗暴露的婴儿数量较少,但结果与其他抗TNF生物制剂的证据令人放心。需要继续监测。
OBJECTIVE: 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.