目的:Vedolizumab用于治疗欧盟的慢性囊炎。我们评估了维多珠单抗是否诱导粘膜愈合(MH)以及MH是否与临床改善相关。
方法:争取,一个随机的,双盲,安慰剂对照研究,评估了维多珠单抗在成人慢性囊炎患者中的疗效和安全性。在基线时进行中央读取内窥镜和组织学评估,周(W)14和W34。溃疡计数,适用于袋内克罗恩病的简单内镜评分(SES-CD),和囊炎疾病活动指数(PDAI)的组织学成分进行评估。在W14和W34时,PDAI和炎症性肠病问卷(IBDQ)缓解率通过W14时的MH状态进行比较。
结果:治疗后,与安慰剂治疗的患者相比,维多珠单抗治疗的患者的平均溃疡数(SD)从W14的15.1(16.4)减少到5.0(4.9),W34的2.7(3.2),相应的值为11.8(11.3),13.4(18.4),和9.7(13.8)(维多珠单抗与安慰剂的差异[95%CI]:W14:-8.4[-14.3,-2.6];W34:-7.0[-12.0,-2.0])。与安慰剂相比,接受维多珠单抗的患者更多的溃疡小袋表面积减少(W14:52.4%vs20.0%;差异32.4p。p[9.7,51.4];W34:52.1%对12.9%;差异40.2p。p[15.6,60.3]),没有溃疡(W14:23.8%vs7.5%;差异16.3p。p[1.1,31.6];W34:34.4%对15.6%;差异18.8p。p[-2.0,39.5]),SES-CD缓解(W14:23.8%vs7.5%;差异16.3p。p[1.1,31.6];W34:34.4%对15.6%;差异18.8p。p[-2.0,39.5])和MH(W14:16.7%vs2.5%;差异14.2p。p[1.9,26.4]).在W14时患有MH的患者在W14和W34时的PDAI和IBDQ缓解率高于没有MH的患者。
结论:维多珠单抗诱导慢性囊炎患者的内镜改善,这与W34时改善的结局相关,特别是在W14时达到MH的患者中。
结果:政府编号,NCT02790138。
OBJECTIVE: Vedolizumab is indicated for the treatment of chronic pouchitis in the European Union. We assessed whether vedolizumab induced mucosal healing (MH) and if MH was associated with clinical improvements.
METHODS: EARNEST, a randomized, double-blind, placebo-controlled study, evaluated vedolizumab efficacy and safety in adults with chronic pouchitis. Centrally read endoscopic and histologic evaluation was performed at baseline, Week (W)14, and W34. Ulcer count, adapted Simple Endoscopic Score for Crohn\'s Disease in the pouch, and Pouchitis Disease Activity Index histologic component were evaluated. Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 were compared by MH status at W14.
RESULTS: Following treatment, mean (standard deviation) number of ulcers in vedolizumab-treated patients reduced from 15.1 (16.4) to 5.0 (4.9) at W14 and 2.7 (3.2) at W34 versus placebo-treated patients with corresponding values of 11.8 (11.3), 13.4 (18.4), and 9.7 (13.8) (vedolizumab vs placebo difference [95% confidence interval]: W14: -8.4 [-14.3 to -2.6]; W34: -7.0 [-12.0 to -2.0]). More patients receiving vedolizumab versus placebo achieved reduction in ulcerated pouch surface area (W14: 52.4% vs 20.0%; difference, 32.4 percentage points [p.p] [9.7, 51.4]; W34: 52.1% vs 12.9%; difference, 40.2p.p [15.6, 60.3]), absence of ulceration (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [-2.0, 39.5]), Simple Endoscopic Score for Crohn\'s Disease remission (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [-2.0, 39.5]), and MH (W14: 16.7% vs 2.5%; difference, 14.2p.p [1.9, 26.4]). Patients with MH at W14 had higher rates of Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 than those without.
CONCLUSIONS: Vedolizumab induced endoscopic improvements in patients with chronic pouchitis, which was associated with improved outcomes at W34, particularly in patients achieving MH at W14. (ClinicalTrials.gov number, NCT02790138.).