Vipul Jairath , Brian G. Feagan , Mark S. Silverberg , Silvio Danese , Paolo Gionchetti , Mark Löwenberg , Brian Bressler , Marc Ferrante , Ailsa Hart , Dirk Lindner , Armella Escher , Stephen Jones , Bo Shen , Simon Travis
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引用次数: 0
Abstract
Background & Aims
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, −2.6]; W34: −7.0 [−12.0, −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.)
背景与目的：在欧盟，维多珠单抗适用于治疗慢性胃袋炎。我们评估了维多珠单抗是否能诱导粘膜愈合（MH），以及粘膜愈合是否与临床改善相关：EARNEST是一项随机、双盲、安慰剂对照研究，评估了维多珠单抗在成人慢性胃袋炎患者中的疗效和安全性。在基线、第14周和第34周进行了中央读取的内镜和组织学评估。评估内容包括溃疡数量、肠袋内克罗恩病简易内镜评分（SES-CD）以及肠袋炎疾病活动指数（PDAI）组织学成分。根据W14和W34时的MH状况，比较了PDAI和炎症性肠病问卷（IBDQ）在W14和W34时的缓解情况：治疗后，与安慰剂治疗患者相比，维多珠单抗治疗患者的平均（标清）溃疡数在W14时从15.1（16.4）减少到5.0（4.9），在W34时减少到2.7（3.2），相应值分别为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 [95%CI]）：W14：-8.4 [-14.3,-2.6]；W34：-7.0 [-12.0,-2.0]）。与安慰剂相比，更多接受维多珠单抗治疗的患者溃疡袋表面积减少（W14：52.4% vs 20.0%；差异32.4p.p [9.7，51.4]；W34：52.1% vs 12.9%；差异40.2p.p [15.6，60.3]），无溃疡（W14：23.8% vs 7.5%；差异16.3p.p [1.1, 31.6]；W34：34.4% vs 15.6%；差异 18.8p.p [-2.0, 39.5]）、SES-CD 缓解（W14：23.8% vs 7.5%；差异 16.3p.p[1.1，31.6]；W34：34.4% vs 15.6%；差异18.8p.p[-2.0，39.5]）和MH（W14：16.7% vs 2.5%；差异14.2p.p[1.9，26.4]）。W14时患有MH的患者在W14和W34时的PDAI和IBDQ缓解率高于未患有MH的患者：结论：维多珠单抗可改善慢性胃袋炎患者的内镜症状，这与W34时的预后改善有关，尤其是在W14时达到MH的患者。
期刊介绍：
Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion.
As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.
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