度普利尤单抗改善嗜酸性粒细胞性食管炎患者的食管扩张性:REMODEL随机试验的24周结果
Dupilumab Improves Esophageal Distensibility in EoE: 24-Week Results From the REMODEL Randomized Trial.
文献信息
| PMID | 42861971 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Evan S Dellon |
| 作者单位 | Professor of Medicine, Director, Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. |
| 期刊 | The American journal of gastroenterology |
| SCI 分区 | Q1 |
| IF | 9.4 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的: 嗜酸性粒细胞性食管炎(EoE)是一种慢性、常呈进行性的2型炎症性疾病,以嗜酸性粒细胞浸润以及食管狭窄和功能障碍为特征。本分析呈现了4期REMODEL试验的24周结局,评估成人EoE患者的长期食管扩张性。
方法: 成人EoE患者按2:1随机分配至度普利尤单抗300 mg每周一次或安慰剂组。对患者进行总体评估,并按基线扩张性平台(DP)低(<17 mm)和正常(≥17 mm)亚组进行评估。第(W)24周终点包括:腔内功能管腔成像探头测量的食管DP直径较基线的绝对变化(主要终点),以及内镜参考评分(EREFS)和EoE组织学评分系统(EoEHSS)分级/分期评分较基线的变化。评估了安全性。
结果: 69例患者(46例度普利尤单抗,23例安慰剂)被随机分配。DP亚组中可评估患者为:30例低基线DP(19例度普利尤单抗,11例安慰剂)和33例正常基线DP(22例度普利尤单抗,11例安慰剂)。在第24周总体人群中,度普利尤单抗较安慰剂改善食管DP直径;最小二乘均值(LSM)(±SE)较基线的绝对变化:+1.28 mm(0.29)和-0.01 mm(0.42);LSM差异:+1.30 mm(95% CI:0.31,2.29;P < 0.05)。低DP亚组中较安慰剂的LSM差异为+2.21 mm(95% CI:0.78,3.63;名义P = 0.0024)。度普利尤单抗较安慰剂在EREFS中的总体LSM差异为-4.96(-6.06,-3.85),在EoEHSS分级和分期评分中分别为-0.71(-0.86,-0.57)和-0.65(-0.80,-0.51)(所有P < 0.0001)。未发现新的安全性信号。
结论: 度普利尤单抗显著改善了第24周食管扩张性结局,低基线DP亚组的改善大于总体人群。(ClinicalTrials.gov,编号NCT06101095)。
英文摘要
OBJECTIVES: Eosinophilic esophagitis (EoE) is a chronic, often progressive, type 2 inflammatory disease characterized by eosinophilic infiltration, and esophageal narrowing and dysfunction. This analysis presents 24-week outcomes from the phase 4 REMODEL trial, evaluating long-term esophageal distensibility in adults with EoE.
METHODS: Adult EoE patients were randomized 2:1 to dupilumab 300 mg once weekly or placebo. Patients were assessed overall and by low (<17 mm) and normal (≥17 mm) baseline distensibility plateau (DP) subgroups. Endpoints at week (W) 24 included: absolute change from baseline in esophageal DP diameter on endoluminal functional lumen imaging probe (primary), and changes from baseline in Endoscopic Reference Scores (EREFS) and EoE histology scoring system (EoEHSS) grade/stage scores. Safety was assessed.
RESULTS: Sixty-nine patients (46 dupilumab, 23 placebo) were randomized. Evaluable patients in the DP subgroups were: 30 low (19 dupilumab, 11 placebo) and 33 normal (22 dupilumab, 11 placebo) baseline DP. At W24 overall, dupilumab improved esophageal DP diameter vs placebo; least squares mean (LSM) (±SE) absolute change from baseline: +1.28 mm (0.29) and -0.01 mm (0.42); LSM difference: +1.30 mm (95% CI: 0.31, 2.29; P < 0.05). LSM difference vs placebo in the low DP subgroup was +2.21 mm (95% CI: 0.78, 3.63; nominal P = 0.0024). Overall LSM difference for dupilumab vs placebo was -4.96 (-6.06, -3.85) in EREFS, and -0.71 (-0.86, -0.57) and -0.65 (-0.80, -0.51) in EoEHSS grade and stage scores, respectively (all P < 0.0001). No new safety signals were identified.
CONCLUSION: Dupilumab significantly improved W24 esophageal distensibility outcomes, with greater improvements in the low baseline DP subgroup compared to the overall population. (ClinicalTrials.gov, number NCT06101095).