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

Abstract

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 swallowed topical corticosteroids (STC) use and with prior inadequate response, intolerance, and/or contraindication (IRIC) to STCs in the phase 3 EoE KIDS study. Eligible patients were aged 1-11 years with EoE unresponsive to proton-pump inhibitors. In part A, patients were randomized to weight-tiered higher-exposure or lower-exposure dupilumab, or placebo up to week (W)16. In part B, dupilumab groups continued treatment, whereas patients receiving placebo switched to higher-exposure or lower-exposure dupilumab through W52. Efficacy by prior STC status was assessed at W16 and W52. 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 seemed comparable in those without prior STC use or prior IRIC, although patient numbers were small. Dupilumab safety was consistent with the known safety profile. Dupilumab may be an effective treatment in children with EoE with prior STC use or prior IRIC to STCs.