克罗恩病患者转换使用抗TNF药物或其他生物制剂的真实世界转归：一项使用德国医保理赔数据的回顾性分析
Real-world outcomes associated with switching to anti-TNFs other biologics in Crohn's Disease patients: A retrospective analysis using German claims data.
作者信息
Zhuleku Evi, Antolin-Fontes Beatriz, Borsi Andras, Nissinen Riikka, Bravatà Ivana, Barthelmes Jennifer Norma, Le Bars Manuela, Lee Jennifer, Passey Alun, Maywald Ulf, Deiters Barthold, Bokemeyer Bernd, Wilke Thomas, Ghiani Marco
机构信息
Cytel Inc., Potsdamer Str. 58, Berlin 10785, Germany.
Cytel Inc., Berlin, Germany.
出版信息
Therap Adv Gastroenterol. 2022 Nov 4;15:17562848221130554. doi: 10.1177/17562848221130554. eCollection 2022.
BACKGROUND
The positioning of new biologic agents for the treatment of Crohn's disease (CD) following failure of initial anti-tumor necrosis factor (anti-TNF) therapy remains a challenge in the real world.
OBJECTIVES
This study aims to investigate the real-world outcomes associated with the sequential use of biologics in CD patients that newly initiate anti-TNFs, specifically comparing those that switch to another anti-TNF biologics with other modes of action.
DESIGN
Retrospective cohort study.
METHODS
We identified CD patients who newly began anti-TNF therapy between 1 October 2014 and 31 December 2018 using two German claims databases. Patients were classified as within-class switchers (WCS) if they switched to another anti-TNF or outside-class switchers (OCS) if they switched to vedolizumab (VDZ) or ustekinumab (UST). To compare WCS and OCS, baseline covariates were adjusted through inverse probability of treatment weighting (IPTW), and time-to-event analyses were performed using Cox Proportional Hazard regressions. Results from both databases were meta-analyzed using an inverse variance model.
RESULTS
Overall, 376 prevalent adult CD patients who initiated anti-TNFs and switched to another biologic were identified. After IPTW, there were 152 and 177 patients in the WCS and OCS group, respectively. WCS were more likely to receive prolonged corticosteroid therapy [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.17-2.27, = 0.004], switch a second time to a different biologic (HR: 2.44, 95% CI: 1.63-3.66, < 0.001), and discontinue treatment (HR: 1.71, 95% CI: 1.25-2.34, = 0.001) than OCS.
CONCLUSION
This study suggests that CD patients exhibit more favorable outcomes when switching outside the anti-TNF class to VDZ or UST after initial anti-TNF failure than switching to a second anti-TNF. With loss of response to anti-TNFs as a concern in the real world, comparative evidence from claims data assessing sequential use of biologics can help optimize treatment algorithms of patients after anti-TNF failure.
背景
在现实世界中，初始抗肿瘤坏死因子（anti-TNF）治疗失败后，新型生物制剂用于治疗克罗恩病（CD）的定位仍然是一项挑战。
目的
本研究旨在调查新开始使用抗TNF药物的CD患者序贯使用生物制剂的真实世界结局，特别比较那些换用另一种抗TNF生物制剂与其他作用方式生物制剂的患者。
设计
回顾性队列研究。
方法
我们使用两个德国索赔数据库，确定了2014年10月1日至2018年12月31日期间新开始抗TNF治疗的CD患者。如果患者换用另一种抗TNF药物，则分类为同类转换者（WCS）；如果换用维多珠单抗（VDZ）或乌司奴单抗（UST），则分类为异类转换者（OCS）。为比较WCS和OCS，通过治疗权重逆概率（IPTW）调整基线协变量，并使用Cox比例风险回归进行事件发生时间分析。使用逆方差模型对两个数据库的结果进行荟萃分析。
结果
总体而言，共确定了376例开始使用抗TNF药物并换用另一种生物制剂的成年CD患者。经过IPTW后，WCS组和OCS组分别有152例和177例患者。与OCS相比，WCS更有可能接受长期糖皮质激素治疗[风险比（HR）：1.63，95%置信区间（CI）：1.17-2.27，P = 0.004]，第二次换用不同生物制剂（HR：2.44，95%CI：1.63-3.66，P < 0.001），以及停止治疗（HR：1.71，95%CI：1.25-2.34，P = 0.001）。
结论
本研究表明，初始抗TNF治疗失败后，CD患者从抗TNF类药物换用VDZ或UST比换用第二种抗TNF药物表现出更有利的结局。鉴于在现实世界中对抗TNF药物反应丧失的担忧，来自索赔数据评估生物制剂序贯使用的比较证据有助于优化抗TNF治疗失败后患者的治疗方案。
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