Article record

临床试验：在随机临床试验中，度普利尤单抗较安慰剂改善嗜酸性食管炎结局，且不受合并症或治疗史影响。

Clinical Trial: Dupilumab Improves Eosinophilic Oesophagitis Outcomes Versus Placebo Regardless of Comorbidities or Treatment History in a Randomised Clinical Trial.

临床研究咽喉科IF 7Q1

文献信息

PMID	42836357
原文	在 PubMed 查看原文 ↗
发表日期	2026
作者	Evan S Dellon 查看其他 7 位作者 Marc E Rothenberg；Jonathan M Spergel；Albert J Bredenoord；Antonella Cianferoni；Changming Xia；Margee Louisias；Allen Radin
作者单位	Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. 查看其他 6 条单位信息 Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.；Division of Allergy and Immunology, Children's Hospital of Philadelphia, Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.；Amsterdam University Medical Center, Amsterdam, the Netherlands.；Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.；Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.；Sanofi, Cambridge, Massachusetts, USA.
期刊	Alimentary pharmacology & therapeutics
SCI 分区	Q1
IF	7
研究类型	临床研究 · 临床
所属专科	咽喉科

中文摘要

背景： 嗜酸性食管炎（EoE）患者可表现出不同的疾病特征、治疗抵抗以及相关的2型炎症合并症。我们在LIBERTY EoE TREET研究中，评估了度普利尤单抗在EoE患者亚组中的疗效，涵盖了一系列人口统计学、特征、治疗和合并症。
方法： 根据体重（< 60 kg或≥ 60 kg）、体重指数（< 18.5 kg/m2、≥ 18.5至< 30 kg/m2、≥ 30 kg/m2）、研究入组前病程（< 5年、≥ 5至< 10年、≥ 10年）、2型炎症合并症史（伴/不伴哮喘、过敏性鼻炎、特应性皮炎或食物过敏）、消除饮食史、同时进行消除饮食、同时使用质子泵抑制剂以及既往食管扩张，将患者分为亚组。结局进行事后分析，包括达到每高倍视野≤ 6个嗜酸性粒细胞（eos/hpf）的患者比例，以及吞咽困难症状问卷（DSQ）和总内镜参考评分（EREFS）较基线的变化。
结果： 在第24周，与安慰剂相比，度普利尤单抗治疗提高了所有亚组中达到组织学缓解（峰值嗜酸性粒细胞计数≤ 6 eos/hpf）的患者比例。在第52周，继续度普利尤单抗治疗维持了改善。在第24周从安慰剂转换为度普利尤单抗的患者中，至第52周也观察到改善。DSQ和EREFS较基线变化也观察到类似结果。
结论： 与安慰剂相比，度普利尤单抗治疗改善了EoE患者的组织学、症状和内镜结局，无论人口统计学、疾病特征、治疗史或2型炎症性疾病合并症如何。
试验注册： ClinicalTrials.gov标识符：NCT03633617。

英文摘要

BACKGROUND: Patients with eosinophilic oesophagitis (EoE) can present with differing disease characteristics, treatment resistance, and associated type 2 inflammatory comorbidities. We assessed the efficacy of dupilumab in subgroups of patients with EoE from the LIBERTY EoE TREET study across a range of demographics, characteristics, treatments, and comorbidities.
METHODS: Patients were categorised by subgroups based on weight (< 60 kg or ≥ 60 kg), body mass index (< 18.5 kg/m2, ≥ 18.5 to < 30 kg/m2, ≥ 30 kg/m2), disease duration before study entry (< 5 years, ≥ 5 to < 10 years, ≥ 10 years), history of type 2 inflammatory comorbidities (with/without asthma, allergic rhinitis, atopic dermatitis, or food allergy), history of elimination diet, concurrent elimination diet, concurrent proton pump inhibitor use, and prior oesophageal dilation. Outcomes were analysed post hoc and included the proportion of patients achieving ≤ 6 eosinophils per high-power field (eos/hpf) and change from baseline in Dysphagia Symptom Questionnaire (DSQ) and total Endoscopic Reference Score (EREFS).
RESULTS: At Week 24, dupilumab treatment increased the proportion of patients achieving histological remission (peak eosinophil count ≤ 6 eos/hpf) versus placebo in all subgroups. At Week 52, improvements were maintained with continued dupilumab treatment. Improvements were also observed through Week 52 in patients who switched from placebo to dupilumab at Week 24. Similar results were observed for change from baseline in DSQ and EREFS.
CONCLUSIONS: Dupilumab treatment improved histological, symptomatic, and endoscopic outcomes versus placebo in patients with EoE, regardless of demographics, disease characteristics, treatment history, or type 2 inflammatory disease comorbidities.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03633617.