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Comparative Effectiveness of Vedolizumab vs. Infliximab Induction Therapy in Ulcerative Colitis: Experience of a Real-World Cohort at a Tertiary Inflammatory Bowel Disease Center

机译:Vedolizumab与Infliximab诱导疗法在溃疡性结肠炎中的比较有效性:第三级炎症性肠病中心的真实队列研究

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Background: Vedolizumab (VDZ), an adhesion molecule inhibitor and infliximab (IFX), a tumor necrosis factor (TNF) blocker, are both approved as first-line induction agents in moderately to severely active ulcerative colitis (UC). However, there are no head-to-head studies comparing the relative effectiveness of the two agents. Here we provide a real-world comparison of these two agents.Methods: We conducted an ambidirectional cohort study of adult UC patients seen at our tertiary inflammatory bowel disease (IBD) center from 2012 to 2017. Each patient had moderately to severely active UC via partial Mayo score and was induced with IFX or VDZ. They were followed until assessment of clinical response. Poisson regression was used to calculate clinical response rates and rate ratios.Results: Of 59 patients who met inclusion criteria, 27 and 32 patients were induced with IFX and VDZ, respectively. Totally, 18/27 (66.7%) patients induced with IFX vs. 24/32 (78.1%) patients induced with VDZ were clinical responders. Response rates per 100 person-weeks (PW) were similar for VDZ (5.21) and IFX (5.38). The effectiveness in terms of induction of clinical response (incidence rate ratio, IRR) was not statistically significant for VDZ vs. IFX (IRR 0.97, 95% confidence interval (CI) 0.53 - 1.77). Among TNF blocker naive patients, IRR was also not statistically significant between VDZ (6.74/100 PW) and IFX (6.48/100 PW) (IRR 1.04, 95% CI 0.47 - 2.29). Among TNF blocker experienced patients, there was a higher response rate for VDZ (4.52) vs. IFX (2.29) per 100 PW, but the IRR did not reveal statistical significance (IRR 1.97, 95% CI 0.45 - 8.63) due to small sample size of TNF blocker experienced patients who received IFX. Five patients developed severe infection or adverse reaction during IFX induction requiring exclusion, whereas no VDZ patients were excluded for this reason.Conclusions: Our study revealed a higher proportion of patients who responded to VDZ vs. IFX; however when accounting for period between induction and assessment of clinical response, rates of clinical response were similar. A key difference between the two groups was the higher response rate in the VDZ group among TNF blocker experienced patients; however, a larger cohort is needed to further elaborate on this difference. VDZ held its own against IFX and this study strengthens its standing as a first-line agent among TNF blocker naive as well as TNF blocker experienced UC patients.Gastroenterol Res. 2018;11(1):41-45doi: https://doi.org/10.14740/gr934w.
机译:背景:维多珠单抗(VDZ)是一种粘附分子抑制剂,英夫利昔单抗(IFX)是一种肿瘤坏死因子(TNF)阻滞剂,均被批准作为中度至重度活动性溃疡性结肠炎(UC)的一线诱导剂。但是,目前尚无针对这两种药物相对有效性的正面研究。在这里,我们提供了这两种药物的真实世界比较。方法:我们对2012年至2017年在我们的三级炎症性肠病(IBD)中心就诊的成年UC患者进行了双向研究。部分Mayo评分,并由IFX或VDZ诱导。一直跟踪直到评估临床反应。结果:在符合入选标准的59例患者中,分别有27例和32例被IFX和VDZ诱发。总共有18/27(66.7%)的IFX诱导患者与24/32(78.1%)的VDZ诱导患者是临床缓解者。 VDZ(5.21)和IFX(5.38)的每100人周(PW)响应率相似。 VDZ与IFX相比,在诱发临床反应(发生率比,IRR)方面的有效性无统计学意义(IRR 0.97,95%置信区间(CI)0.53-1.77)。在未使用TNF阻断剂的患者中,VDZ(6.74 / 100 PW)和IFX(6.48 / 100 PW)之间的IRR差异也无统计学意义(IRR 1.04,95%CI 0.47-2.29)。在经历TNF阻滞剂治疗的患者中,每100 PW VDZ(4.52)高于IFX(2.29),但由于样本少,IRR并未显示出统计学意义(IRR 1.97,95%CI 0.45-8.63)接受IFX治疗的经验丰富的TNF阻滞剂患者。五名患者在IFX诱导期间发生严重感染或不良反应,需要排除,而没有VDZ患者因此被排除在外。结论:我们的研究显示,对VDZ做出反应的患者比例高于IFX。但是,在考虑诱导和评估临床反应之间的时间段时,临床反应率相似。两组之间的主要区别是,经历过TNF阻滞剂治疗的患者中VDZ组的反应率更高;但是,需要更大的队列来进一步阐明这种差异。 VDZ对IFX持反对态度,这项研究巩固了其作为TNF阻断剂天真和TNF阻断剂经验丰富的UC患者中一线药物的地位。 2018; 11(1):41-45doi:https://doi.org/10.14740/gr934w。

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