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. 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. 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. Vedolizumab induced endoscopic improvements in patients with chronic pouchitis, which was associated with improved outcomes at W34, particularly in patients achieving MH at W14. ( number, NCT02790138.)

中文翻译：

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维多珠单抗治疗慢性储袋炎患者的粘膜愈合：EARNEST，一项随机、双盲、安慰剂对照试验


维多珠单抗在欧盟适用于治疗慢性储袋炎。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。 EARNEST 是一项随机、双盲、安慰剂对照研究，评估了维多珠单抗对成人慢性储袋炎的疗效和安全性。在基线、第 14 周和第 34 周进行集中读取内窥镜和组织学评估。评估了溃疡计数、育儿袋克罗恩病的简单内窥镜评分以及育儿袋炎疾病活动指数组织学成分。通过第 14 周的 MH 状态比较第 14 周和第 34 周时的贮袋炎疾病活动指数和炎症性肠病问卷缓解。治疗后，与安慰剂治疗患者相比，维多珠单抗治疗患者的溃疡平均数（标准差）在第 14 周从 15.1 (16.4) 减少至 5.0 (4.9)，在第 34 周从 2.7 (3.2) 减少至 11.8 (11.3)， 13.4 (18.4) 和 9.7 (13.8)（维多珠单抗与安慰剂差异[95% 置信区间]：W14：-8.4 [-14.3 至 -2.6]；W34：-7.0 [-12.0 至 -2.0]）。与安慰剂相比，更多接受维多珠单抗的患者溃疡性储袋表面积减少（第 14 周：52.4% 对比 20.0%；差异，32.4 个百分点 [pp] [9.7, 51.4]；第 34 周：52.1% 对比 12.9%；差异，40.2% [15.6] ，60.3]），无溃疡（第 14 周：23.8% vs 7.5%；差异，16.3pp [1.1, 31.6]；第 34 周：34.4% vs 15.6%；差异，18.8pp [−2.0, 39.5]），简单内镜评分克罗恩病缓解（第 14 周：23.8% vs 7.5%；差异，16.3pp [1.1, 31.6]；第 34 周：34.4% vs 15.6%；差异，18.8pp [−2.0, 39.5]）和 MH（第 14 周：16.7%） vs 2.5%；差异 14.2pp [1.9, 26.4]）。 第 14 周患有 MH 的患者在第 14 周和第 34 周的贮袋炎疾病活动指数和炎症性肠病问卷缓解率高于未患有 MH 的患者。维多珠单抗诱导慢性储袋炎患者内镜检查改善，这与第 34 周结果的改善相关，特别是第 14 周达到 MH 的患者。 （编号，NCT02790138。)