Vedolizumab Versus Other Biologics and the Risk of Venous Thromboembolism in Patients with Pediatric-Onset Inflammatory Bowel Diseases: A Target Trial Emulation Study.

IF 3.7 3区医学 Q1 PEDIATRICS

Pediatric Drugs Pub Date : 2025-11-01 Epub Date: 2025-10-08 DOI:10.1007/s40272-025-00717-2

Serena Yun-Chen Tsai, Ashwin N Ananthakrishnan, Harland S Winter, Kevin Sheng-Kai Ma

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引用次数: 0

Abstract

Background: Pediatric-onset inflammatory bowel diseases (IBD) are associated with an elevated risk of venous thromboembolism (VTE). However, data on the VTE risk in these patients treated with novel biologics, particularly vedolizumab, remain limited.

Aims: To evaluate the association between vedolizumab and the risk of VTE compared with other biologics in patients with pediatric-onset Crohn's disease (CD) or ulcerative colitis (UC).

Methods: We emulated a target trial using electronic health records from the TriNetX research network. The study included patients with CD or UC diagnosed before the age of 18 years who were treated with vedolizumab, ustekinumab, or anti-tumor necrosis factor (TNF) agents. Comparative groups were generated using 1:1 propensity-score matching based on relevant confounders. The primary outcome was the occurrence of any VTE within 12 months of follow-up. Cox proportional hazards models were used to compare the risk of VTE between vedolizumab-treated patients and those treated with anti-TNF agents and ustekinumab.

Results: A total of 1806 matched patient pairs were analyzed across four comparisons: patients treated with vedolizumab versus anti-TNF agents (CD = 407 pairs; UC = 443 pairs), and vedolizumab versus ustekinumab (CD = 563 pairs; UC = 393 pairs), respectively. Patients with CD receiving vedolizumab had a significantly higher risk of VTE compared with those receiving anti-TNF therapy (hazard ratio [HR] 8.63; 95% confidence interval [CI] 1.08-69.10; p = 0.014). A higher VTE risk was also observed in vedolizumab-treated patients with CD compared with those treated with ustekinumab (HR 4.64; 95% CI 1.35-15.97; p = 0.007). In contrast, no significant difference in VTE risk was found between vedolizumab and either comparator group in patients with UC.

Conclusions: Treatment with vedolizumab was associated with a higher incidence of VTE than anti-TNF agents or ustekinumab among individuals with CD. Prospective cohort studies are warranted to validate the safety of biologic therapy for pediatric patients with CD.

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Vedolizumab与其他生物制剂和儿科起病炎症性肠病患者静脉血栓栓塞的风险：一项目标试验模拟研究

背景：儿科起病的炎症性肠病（IBD）与静脉血栓栓塞（VTE）的风险升高相关。然而，使用新型生物制剂（特别是vedolizumab）治疗的这些患者的静脉血栓栓塞风险数据仍然有限。目的：评估与其他生物制剂相比，vedolizumab与儿科发病克罗恩病（CD）或溃疡性结肠炎（UC）患者VTE风险之间的关系。方法：我们使用来自TriNetX研究网络的电子健康记录模拟目标试验。该研究纳入了18岁之前诊断为CD或UC的患者，他们接受了维多单抗、乌斯特金单抗或抗肿瘤坏死因子（TNF）药物的治疗。采用基于相关混杂因素的1:1倾向得分匹配生成比较组。主要结局是随访12个月内静脉血栓栓塞的发生情况。Cox比例风险模型用于比较维多单抗治疗患者与抗肿瘤坏死因子药物和乌斯特金单抗治疗患者的静脉血栓栓塞风险。结果：共有1806对匹配的患者对通过四组比较进行了分析：分别使用vedolizumab与抗tnf药物治疗的患者（CD = 407对；UC = 443对），以及vedolizumab与ustekinumab （CD = 563对；UC = 393对）。与接受抗肿瘤坏死因子治疗的患者相比，接受vedolizumab治疗的CD患者发生静脉血栓栓塞的风险明显更高（风险比[HR] 8.63； 95%可信区间[CI] 1.08-69.10; p = 0.014）。与ustekinumab治疗的CD患者相比，vedolizumab治疗的CD患者的静脉血栓栓塞风险也更高（HR 4.64; 95% CI 1.35-15.97; p = 0.007）。相比之下，在UC患者中，vedolizumab与任何比较组之间的静脉血栓栓塞风险均无显著差异。结论：在乳糜泻患者中，与抗肿瘤坏死因子或乌斯特金单抗相比，使用vedolizumab治疗与更高的静脉血栓栓塞发生率相关。有必要进行前瞻性队列研究，以验证儿科乳糜泻患者生物治疗的安全性。

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

Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY

CiteScore

7.20

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. 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 Pediatric 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.