Dupilumab Efficacy in Children With Eosinophilic Esophagitis With Prior Swallowed Topical Corticosteroid Use: A Subgroup Analysis.

We assessed dupilumab efficacy in children with EoE with prior swallowed topical corticosteroids (STC) use and with prior inadequate response, intolerance, and/or contraindication (IRIC) to STCs in the phase 3 EoE KIDS study.

我们在EoE KIDS第三阶段研究中评估了既往使用过口服局部皮质类固醇(STC)且对STCs有先前不充分反应、不耐受和/或禁忌症(IRIC)的儿童EoE患者中dupilumab的疗效。

Methods

Eligible patients were aged 1-11 years with EoE unresponsive to proton-pump inhibitors.

符合条件的患者年龄在1-11岁之间，患有对质子泵抑制剂无反应的嗜酸性食管炎。

In part A, patients were randomized to weight-tiered higher-exposure or lower-exposure dupilumab, or placebo up to week (W)16.

在A部分，患者被随机分配到按体重分层的高剂量或低剂量的dupilumab治疗，或安慰剂，治疗至第16周。

In part B, dupilumab groups continued treatment, whereas patients receiving placebo switched to higher-exposure or lower-exposure dupilumab through W52.

在B部分，达普利单抗组继续接受治疗，而接受安慰剂的患者在第52周转为更高或更低剂量的达普利单抗治疗。

Efficacy by prior STC status was assessed at W16 and W52.

在第16周和第52周，根据先前的STC状态评估了疗效。

Results

Of 102 patients, 82 (80%) received prior STCs and 59 (58%) had prior IRIC to STCs.

在102名患者中，有82名（80%）接受了先前的STC治疗，59名（58%）有先前对STC的IRIC。

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).

在第16周，较高剂量的dupilumab在有先前STC使用史的患者中改善了组织学缓解率，与安慰剂相比（60.7%对0.0%，名义P<0.0001），以及在有先前对STC的IRIC的患者中（60.9%对0.0%，名义P<0.0001）。

Secondary endoscopic and histologic outcomes were similar.

次要内镜和组织学结果相似。

Responses were maintained at W52 with higher-exposure dupilumab, with improvements observed in patients who switched from placebo to higher-exposure dupilumab.

W52时，高剂量度普利尤单抗组的反应得以维持，从安慰剂转为高剂量度普利尤单抗的患者观察到改善。

Results were similar or numerically lower with lower-exposure dupilumab.

低暴露度度普利尤单抗的结果相似或数值上较低。

Findings seemed comparable in those without prior STC use or prior IRIC, although patient numbers were small.

在没有先前使用STC或IRIC的患者中，发现的结果似乎相当，尽管患者数量较少。

Dupilumab safety was consistent with the known safety profile.

Dupilumab的安全性与其已知的安全性档案一致。

Discussion

Dupilumab may be an effective treatment in children with EoE with prior STC use or prior IRIC to STCs.

对于之前使用过STC或对STC有先前免疫反应的儿童，Dupilumab可能是治疗EoE的有效方法。