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

Abstract

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.

Keywords: dupilumab; eosinophilic esophagitis; pediatric; swallowed topical corticosteroids.