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

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY Pharmacoepidemiology and Drug Safety Pub Date : 2024-08-01 DOI:10.1002/pds.5878

Pär Karlsson, Karin Gembert, Suzan Esslinger, Anja Geldhof, Mika Gissler, Maarit K Leinonen, Marijo Otero-Lobato, Lars Pedersen, Carolyn E Cesta

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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.

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2006-2019年丹麦、芬兰和瑞典产前接触戈利木单抗后的妊娠和婴儿结局。

目的：介绍一项授权后安全性研究的主要结果，该研究评估了在真实世界环境中产前接触戈利木单抗后的妊娠和婴儿结局：这项基于人群的观察性队列研究纳入了2006-2018年（芬兰）或2019年（丹麦、瑞典）结束的妊娠数据。对诊断患有风湿性疾病或溃疡性结肠炎的妇女所生的婴儿进行了鉴定。根据从怀孕前90天到分娩前的处方开具情况，婴儿被分配到四个药物暴露队列之一：戈利木单抗、其他抗肿瘤坏死因子生物制剂、其他生物制剂、非生物系统疗法和普通人群。对婴儿出生后第一年的不良妊娠结局、死亡率、重大先天性畸形（MCA）诊断和住院感染的发生率进行了评估。计算了MCA和感染的比值比和95% CI：在戈利木单抗队列的134名婴儿中，没有死胎或在出生后第一年死亡。戈利木单抗队列中有4.5%的婴儿确诊为MCA，而其他抗肿瘤坏死因子生物制剂、其他生物制剂、非生物系统疗法和普通人群队列中的MCA确诊率分别为6.8%、10.9%、5.5%和4.6%。在戈利木单抗暴露的婴儿中，有11%被诊断出住院感染，而在其他队列中，这一比例为9%-11%。与其他暴露队列或普通人群相比，未经调整和选定调整的比较结果显示，产前戈利木单抗暴露与MCA或感染之间没有关联：产前暴露于戈利木单抗的婴儿数量较少，但令人欣慰的是，其结果与其他抗肿瘤坏死因子生物制剂的现有证据一致。需要继续监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.