Second-Line Biologic Therapy Following Tumor Necrosis Factor Antagonist Failure: A Real-World Propensity Score-Weighted Analysis.
Second-Line Biologic Therapy Following Tumor Necrosis Factor Antagonist Failure: A Real-World Propensity Score-Weighted Analysis.
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肿瘤坏死因子拮抗剂失败后的二线生物治疗：现实世界倾向评分加权分析。
DOI：
10.1016/j.cgh.2023.01.038
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Ungaro,RyanC
中科院分区：
文献类型：
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作者：
Ibing,Susanne;Cho,JudyH;Böttinger,ErwinP;Ungaro,RyanC
背景与目的肿瘤坏死因子（TNF）拮抗剂常被用作治疗中重度炎症性肠病（IBD）的一线药物，但许多患者不能达到或维持反应。我们的目的是比较二线治疗的有效性在来自2个基于电子健康记录的队列的克罗恩病（CD）和溃疡性结肠炎（UC）患者中，在TNF拮抗剂暴露后（优特克单抗、维多珠单抗或第二种TNF拮抗剂），（CD，n = 527; UC，n = 165）和来自克罗恩病和结肠炎基金会的炎性肠病丛计划的前瞻性成人研究队列（CET）的研究（CD，n = 412; UC，n = 129）。治疗失败定义为任何IBD相关手术、IBD相关住院、口服/静脉注射皮质类固醇新处方或需要改用第三种生物制剂的复合事件。时间到事件的分析进行了治疗加权data.ResultsOverall，治疗失败发生在85%的MSHS和72%的CDMACD患者的逆概率。在Vedolizumab中，与Vedolizumab作为二线治疗相比，乌司奴单抗治疗失败的可能性显著降低（校正风险比，0.66; 95% CI，0.54-0.82;P< .001），这一趋势在MSHS中得到证实（校正风险比，0.89; 95% CI，0.77-1.04;P= .15）。在两个队列中，当将治疗失败视为类固醇或第三种生物制剂处方时，显示乌司奴单抗优于Vedolizumab。在UC，二线治疗组之间没有差异indicated.ConclusionsIn 2个独立的现实世界的队列设置，二线治疗CD与乌司奴单抗TNF拮抗剂治疗失败后与治疗失败的可能性较低比二线Vedolizumab。
Background& AimsTumor necrosis factor (TNF) antagonists often are used as first-line medications to treat moderate to severe inflammatory bowel disease (IBD), but many patients do not achieve or maintain response. Our aim was to compare the effectiveness of second-line treatments (ustekinumab, vedolizumab, or a second TNF antagonist) after TNF antagonist exposure in patients with Crohn’s disease (CD) and ulcerative colitis (UC) from 2 electronic health records–based cohorts.MethodsWe identified patients with prior TNF antagonist exposure who switched to a different biologic in the Mount Sinai Health System (MSHS) electronic health records (CD, n = 527; UC, n = 165) and the Study of a Prospective Adult Research Cohort (SPARC) from the Inflammatory Bowel Disease Plexus Program of the Crohn’s & Colitis Foundation (CD, n = 412; UC, n = 129). Treatment failure was defined as the composite of any IBD-related surgery, IBD-related hospitalization, new prescription of oral/intravenous corticosteroids, or need to switch to a third biologic agent. Time-to-event analysis was conducted with inverse probability of treatment-weighted data.ResultsOverall, treatment failure occurred in 85% of MSHS and 72% of SPARC CD patients. In SPARC, the likelihood of treatment failure was significantly lower with ustekinumab compared with vedolizumab as second-line treatment (adjusted hazard ratio, 0.66; 95% CI, 0.54–0.82;P< .001), a trend confirmed in MSHS (adjusted hazard ratio, 0.89; 95% CI, 0.77–1.04;P= .15). In both cohorts, the superiority of ustekinumab compared with vedolizumab was shown when considering treatment failure as prescription of steroids or a third biologic agent. In UC, no differences between second-line treatment groups were identified.ConclusionsIn 2 independent real-world cohort settings, second-line therapy in CD with ustekinumab after TNF antagonist treatment failure was associated with a lower likelihood of treatment failure than second-line vedolizumab.