Real-World Persistence of Successive Biologics in Patients With Inflammatory Bowel Disease: Findings From ROTARY.

IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Noa Krugliak Cleveland, Sabyasachi Ghosh, Benjamin Chastek, Tim Bancroft, Ninfa Candela, Tao Fan, Kandavadivu Umashankar, David T Rubin
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Abstract

Background: Patients with inflammatory bowel disease (IBD) may receive multiple successive biologic treatments in clinical practice; however, data are limited on the comparative effectiveness of biologics and the impact of treatment sequence on outcomes.

Methods: The ROTARY (Real wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) study was a retrospective, observational cohort study conducted using data from the Optum Clinical Database between January 1, 2012, and February 29, 2020. Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) who received 2 biologics successively were included. Biologic treatment sequences were analyzed descriptively. Cox proportional hazards models, adjusted for baseline demographics and clinical characteristics, were used to estimate the hazard ratio of switching or discontinuation for each first- and second-line biologic compared with first- and second-line adalimumab, respectively.

Results: In total, 4648 patients with IBD (CD, n = 3008; UC, n = 1640) were identified. Most patients received tumor necrosis factor α antagonist (anti-TNFα) treatment followed by another anti-TNFα treatment or vedolizumab. Vedolizumab and infliximab had 39.4% and 34.6% lower rates of switching or discontinuation than adalimumab, respectively, as first-line biologics in patients with CD and 30.8% and 34.3% lower rates as first-line biologics in patients with UC, respectively. Vedolizumab, infliximab, and ustekinumab had 47.2%, 40.0%, and 43.5% lower rates of switching or discontinuation than adalimumab, respectively, as second-line biologics in CD and 56.5%, 43.0%, and 45.6% lower rates as second-line biologics in patients with UC, respectively.

Conclusions: Although anti-TNFα treatments were most commonly prescribed, the adjusted rates of discontinuation for adalimumab as both a first- and second-line biologic were higher than for vedolizumab, infliximab, or ustekinumab.

连续生物制品在炎症性肠病患者中的真实世界持久性:ROTARY的研究结果。
背景:炎症性肠病(IBD)患者在临床实践中可能会接受多次连续的生物治疗;然而,关于生物制剂的比较有效性和治疗顺序对结果的影响的数据有限。方法:ROTARY(炎症性肠病患者t反应序列中的真实wOrld ouTcomes)研究是一项回顾性观察性队列研究,使用Optum临床数据库的数据在2012年1月1日至2020年2月29日期间进行。包括先后接受2种生物制剂治疗的克罗恩病(CD)或溃疡性结肠炎(UC)成年患者。对生物处理序列进行描述性分析。Cox比例风险模型根据基线人口统计和临床特征进行了调整,用于估计每种一线和二线生物制剂分别与一线和二线阿达木单抗相比切换或停用的风险比。结果:共发现4648例IBD患者(CD,n=3008;UC,n=1640)。大多数患者接受肿瘤坏死因子α拮抗剂(抗TNFα)治疗,然后接受另一种抗TNFα治疗或维多利珠单抗。在CD患者中,韦多利珠单抗和英夫利昔单抗作为一线生物制剂的转换或停用率分别比阿达木单抗低39.4%和34.6%,在UC患者中,作为一线生物制品的转换或停药率分别低30.8%和34.3%。韦多利珠单抗、英夫利昔单抗和ustekinumab作为CD的二线生物制剂的转换或停用率分别比阿达木单抗低47.2%、40.0%和43.5%,作为UC患者的二线生物制品的转换或停药率分别低56.5%、43.0%和45.6%。结论:尽管抗TNFα治疗是最常见的处方,但阿达木单抗作为一线和二线生物制剂的调整停药率高于维多利珠单抗、英夫利昔单抗或ustekinumab。
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来源期刊
Inflammatory Bowel Diseases
Inflammatory Bowel Diseases 医学-胃肠肝病学
CiteScore
9.70
自引率
6.10%
发文量
462
审稿时长
1 months
期刊介绍: Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.
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