杜匹单抗治疗嗜酸性食管炎患儿既往吞下局部皮质类固醇疗效:亚组分析

Mirna Chehade,Salvatore Oliva,Dhandapani Ashok,Ruiqi Liu,Jennifer Maloney,Raolat M Abdulai,Margee Louisias,Allen Radin
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引用次数: 0

摘要

外用糖皮质激素(STCs)常用于治疗嗜酸性食管炎(EoE);然而,并不是所有的患者都有反应,有些患者可能不耐受或有禁忌症。在3期EoE KIDS研究中,我们评估了dupilumab在既往使用STC的EoE儿童以及既往对STC反应不足/不耐受/禁忌症(IRIC)的EoE儿童中的疗效。方法入选的患者年龄为1-11岁,EoE对质子泵抑制剂无反应。在A部分,患者被随机分配到体重分级高或低剂量dupilumab或安慰剂组,直到第16周。在B部分,dupilumab组继续治疗,而接受安慰剂的患者通过W52切换到更高或更低剂量的dupilumab。在W16和W52时评估既往STC状态的疗效。结果102例患者中,82例(80%)既往有STCs, 59例(58%)既往有IRIC。在W16时,与安慰剂相比,高剂量dupilumab改善了先前使用STC的患者的组织学缓解率(60.7% vs 0.0%,标称P < 0.0001)和先前使用STC的IRIC (60.9% vs 0.0%,标称P < 0.0001)。二次内镜和组织学结果相似。高剂量dupilumab组的反应维持在W52,从安慰剂切换到高剂量dupilumab组的患者观察到改善。低剂量dupilumab的结果相似或数值更低。尽管患者数量较少,但未使用STC或IRIC的患者的结果相似。Dupilumab的安全性与已知的安全性一致。dupilumab可能是既往使用STC的EoE儿童或既往使用STC的IRIC的有效治疗方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Dupilumab Efficacy in Children With Eosinophilic Esophagitis With Prior Swallowed Topical Corticosteroid Use: A Subgroup Analysis.
INTRODUCTION Swallowed topical corticosteroids (STCs) are commonly used to treat eosinophilic esophagitis (EoE); however, not all patients respond, and others may be intolerant or have contraindications. We assessed dupilumab efficacy in children with EoE with prior STC use, and with prior inadequate response/intolerance/contraindication (IRIC) to STCs in the phase 3 EoE KIDS study. METHODS Eligible patients were aged 1-11 years with EoE unresponsive to proton-pump inhibitors. In Part A, patients were randomized to weight-tiered higher- or lower-exposure dupilumab, or placebo up to Week (W)16. In Part B, dupilumab groups continued treatment, while patients receiving placebo switched to higher- or lower-exposure dupilumab through W52. Efficacy by prior STC status was assessed at W16 and W52. RESULTS Of 102 patients, 82 (80%) received prior STCs and 59 (58%) had prior IRIC to STCs. At W16, higher-exposure dupilumab improved rates of histologic remission vs placebo in patients with prior STC use (60.7% vs 0.0%, nominal P < 0.0001) and prior IRIC to STCs (60.9% vs 0.0%, nominal P < 0.0001). Secondary endoscopic and histologic outcomes were similar. Responses were maintained at W52 with higher-exposure dupilumab, with improvements observed in patients who switched from placebo to higher-exposure dupilumab. Results were similar or numerically lower with lower-exposure dupilumab. Findings appeared comparable in those without prior STC use or prior IRIC, although patient numbers were small. Dupilumab safety was consistent with the known safety profile. DISCUSSION Dupilumab may be an effective treatment in children with EoE with prior STC use, or prior IRIC to STCs.
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