炎症性肠病患者连续使用生物制剂的真实持久性:来自 ROTARY 的研究结果。
Real-World Persistence of Successive Biologics in Patients With Inflammatory Bowel Disease: Findings From ROTARY.
发表日期:2023 Oct 31
作者:
Noa Krugliak Cleveland, Sabyasachi Ghosh, Benjamin Chastek, Tim Bancroft, Ninfa Candela, Tao Fan, Kandavadivu Umashankar, David T Rubin
来源:
Disease Models & Mechanisms
摘要:
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以及治疗顺序对结果的影响的数据有限。ROTARY(炎症性肠病患者治疗顺序的真实世界结果)研究是一项回顾性、观察性队列研究,使用来自 Optum Clinical 的数据进行数据库于2012年1月1日至2020年2月29日期间。纳入连续接受2种生物制剂的克罗恩病(CD)或溃疡性结肠炎(UC)成年患者。对生物治疗顺序进行了描述性分析。根据基线人口统计和临床特征进行调整的 Cox 比例风险模型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转换或停药的风险比。总共 4648 名患者确定患有 IBD(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治疗或维多珠单抗。作为 CD 患者的一线生物制剂,维多珠单抗和英夫利昔单抗的转换或停药率分别比阿达木单抗低 39.4% 和 34.6%,作为 UC 患者的一线生物制剂的换药或停药率分别低 30.8% 和 34.3%。维多珠单抗、英夫利昔单抗和乌特克单抗作为 CD 的二线生物制剂,其转换或停药率分别比阿达木单抗低 47.2%、40.0% 和 43.5%,作为二线生物制剂则比阿达木单抗低 56.5%、43.0% 和 45.6% UC 患者分别使用生物制剂。尽管抗 TNFα 治疗最常用,但阿达木单抗作为一线和二线生物制剂的调整后停药率高于维多珠单抗、英夫利昔单抗或优特克单抗。© 2023 Crohn's
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.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.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.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.© 2023 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.