Dupilumab is efficacious for eosinophilic esophagitis irrespective of prior swallowed budesonide or fluticasone, or prior treatments used alongside swallowed topical corticosteroids: results from the phase 3, randomized, placebo-controlled, LIBERTY EoE TREET trial.

IF 3.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Albert J Bredenoord, Evan S Dellon, Christoph Schlag, Antonella Cianferoni, Changming Xia, Tiffany Pela, Sandy Durrani, Amr Radwan, Juby A Jacob-Nara
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引用次数: 0

Abstract

Background: Standard treatments for eosinophilic esophagitis (EoE) may present adherence, tolerance, and efficacy challenges. Dupilumab 300 mg weekly is approved for the treatment of EoE in patients ≥ 1 year old, weighing ≥ 15 kg. This analysis aimed to evaluate dupilumab efficacy in patients from the LIBERTY EoE TREET trial (NCT03633617), with prior history of different EoE interventions.

Research design and methods: This analysis included patients from Parts B/B - C of LIBERTY EoE TREET. Dupilumab efficacy was analyzed according to prior swallowed budesonide or fluticasone use and in those patients with previously trialed food elimination diet, esophageal dilation, or baseline proton pump inhibitor use, as stratified by prior swallowed topical corticosteroid (STC) use or STC inadequate response/intolerance/contraindication.

Results: Dupilumab improved the proportion of patients achieving peak intraepithelial eosinophil count ≤ 6 eosinophils/high-power field, absolute change in Dysphagia Symptom Questionnaire score, and other histologic, symptomatic, and endoscopic endpoints vs. placebo at Week (W) 24, irrespective of prior swallowed budesonide/fluticasone use. Improvements were maintained at W52. Similar results were observed across the other subgroups.

Conclusion: Dupilumab was efficacious in patients with EoE irrespective of prior treatments/interventions.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT03633617.

Dupilumab对嗜酸性食管炎是有效的,与之前吞下布地奈德或氟替卡松无关,或之前与吞下局部皮质类固醇一起治疗:来自3期随机、安慰剂对照的LIBERTY EoE TREET试验的结果。
背景:嗜酸性粒细胞性食管炎(EoE)的标准治疗可能存在依从性、耐受性和疗效方面的挑战。Dupilumab每周300 mg被批准用于治疗≥1岁,体重≥15 kg的EoE患者。该分析旨在评估dupilumab对LIBERTY EoE TREET试验(NCT03633617)患者的疗效,这些患者既往有不同的EoE干预史。研究设计和方法:本分析纳入了LIBERTY EoE街B/B - C部分的患者。根据既往吞咽布地奈德或氟替卡松的使用情况,以及先前试验过食物消除饮食、食管扩张或基线质子泵抑制剂使用的患者,对Dupilumab的疗效进行分析,并根据既往吞咽外用皮质类固醇(STC)或STC不充分反应/不耐受/禁忌症进行分层。结果:与安慰剂相比,Dupilumab在第24周提高了达到上皮内嗜酸性粒细胞计数峰值≤6 /高倍视场的患者比例,吞咽困难症状问卷评分的绝对变化,以及其他组织学、症状和内镜终点,无论是否服用过布地奈德/氟替卡松。W52保持了改善。在其他亚组中也观察到类似的结果。结论:Dupilumab对EoE患者有效,与既往治疗/干预无关。临床试验注册:www.clinicaltrials.gov标识符:NCT03633617。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Expert Review of Gastroenterology & Hepatology
Expert Review of Gastroenterology & Hepatology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
6.80
自引率
2.60%
发文量
86
审稿时长
6-12 weeks
期刊介绍: The enormous health and economic burden of gastrointestinal disease worldwide warrants a sharp focus on the etiology, epidemiology, prevention, diagnosis, treatment and development of new therapies. By the end of the last century we had seen enormous advances, both in technologies to visualize disease and in curative therapies in areas such as gastric ulcer, with the advent first of the H2-antagonists and then the proton pump inhibitors - clear examples of how advances in medicine can massively benefit the patient. Nevertheless, specialists face ongoing challenges from a wide array of diseases of diverse etiology.
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