A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013-2021.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-02-06 DOI:10.1007/s40264-025-01519-8

Annette Kjær Ersbøll, Zhiping Huang, Deanna D Hill, Simone Møller Hede, Vibeke Andersen, Kristian Bolin, Marie Skov Kristensen, Suzan Esslinger, Frida Richter Hansen, Erik Hertervig, Lila Kallio, Thora Majlund Kjærulff, Stine Kloster, Alexis Krumme, James D Lewis, Laila Mehkri, Niels Qvist, Lau Caspar Thygesen, Cindy Weinstein, Anders Green

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引用次数: 0

Abstract

Background: When golimumab (GLM) was approved for the treatment of moderate to severe ulcerative colitis (UC) in 2013, a post-authorization safety study was conducted.

Objective: Our objective was to examine whether exposure to GLM was associated with an increased incidence of all-cause total colectomy, colorectal cancer, and hepatosplenic T-cell lymphoma in Denmark and Sweden.

Methods: We conducted a new-user, active comparator cohort study of patients with UC in 2013-2021. Exposure to GLM, other anti-tumor necrosis factor (TNF) agents (infliximab and adalimumab) and thiopurines was a time-varying variable. Therapies were based on prescription redemptions and hospital-based administration of medications from national prescription and hospital registers. The association between exposure to study therapies and outcomes was evaluated using Poisson regression of incidence rates (IRs), presented as IR ratios (IRRs) and 95% confidence intervals (CIs).

Results: A total of 5177 and 7469 patients were included in Denmark and Sweden, respectively. The IR of all-cause total colectomy per 1000 person-years was higher in Denmark (IR 42.6; 95% CI 38.9-46.2) than in Sweden (IR 16.1; 95% CI 14.2-18.0). No significant difference was observed in all-cause total colectomy between GLM and other anti-TNF agents (Denmark: adjusted IRR [aIRR] 1.28; 95% CI 0.98-1.66; Sweden: aIRR 1.17; 95% CI 0.72-1.90). A significant difference was observed between GLM and thiopurines (Denmark: aIRR 13.62; 95% CI 8.73-21.26; Sweden: aIRR 4.52; 2.75-7.41). Privacy regulations prevented analysis of a few colorectal cancer events. No hepatosplenic T-cell lymphoma events were identified.

Conclusion: The IR of all-cause total colectomy with GLM was similar to that with other anti-TNF agents but was much higher than with thiopurines, probably related to confounding by indication.

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Golimumab治疗溃疡性结肠炎的纵向安全性研究：2013-2021年丹麦和瑞典的队列研究

背景：当golimumab （GLM）在2013年被批准用于治疗中重度溃疡性结肠炎（UC）时，进行了一项授权后安全性研究。目的：我们的目的是研究暴露于GLM是否与丹麦和瑞典全因结肠切除术、结直肠癌和肝脾t细胞淋巴瘤的发病率增加有关。方法：我们在2013-2021年对UC患者进行了一项新用户、活跃的比较队列研究。暴露于GLM、其他抗肿瘤坏死因子（TNF）药物（英夫利昔单抗和阿达木单抗）和硫嘌呤是一个时变变量。治疗是基于处方赎回和以医院为基础的国家处方和医院登记的药物管理。使用泊松回归发生率（IRs）评估研究治疗暴露与结果之间的关系，以IR比率（IRRs）和95%置信区间（CIs）表示。结果：丹麦和瑞典共纳入5177例和7469例患者。丹麦的全因结肠切除术每1000人年的IR更高(IR 42.6；95% CI 38.9-46.2)高于瑞典(IR 16.1；95% ci 14.2-18.0)。GLM与其他抗肿瘤坏死因子药物在全因全结肠切除术中无显著差异(丹麦：调整IRR [aIRR] 1.28；95% ci 0.98-1.66；瑞典：aIRR 1.17；95% ci 0.72-1.90)。GLM和硫嘌呤之间存在显著差异(丹麦：aIRR 13.62；95% ci 8.73-21.26；瑞典：aIRR 4.52；2.75 - -7.41)。隐私法规阻止了对一些结直肠癌事件的分析。未发现肝脾t细胞淋巴瘤事件。结论：GLM全因全结肠切除术的IR与其他抗tnf药物相似，但远高于硫嘌呤，可能与适应症混淆有关。

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

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.