Mirna Chehade,Salvatore Oliva,Dhandapani Ashok,Ruiqi Liu,Jennifer Maloney,Raolat M Abdulai,Margee Louisias,Allen Radin
{"title":"Dupilumab Efficacy in Children With Eosinophilic Esophagitis With Prior Swallowed Topical Corticosteroid Use: A Subgroup Analysis.","authors":"Mirna Chehade,Salvatore Oliva,Dhandapani Ashok,Ruiqi Liu,Jennifer Maloney,Raolat M Abdulai,Margee Louisias,Allen Radin","doi":"10.14309/ajg.0000000000003599","DOIUrl":null,"url":null,"abstract":"INTRODUCTION\r\nSwallowed 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.\r\n\r\nMETHODS\r\nEligible 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.\r\n\r\nRESULTS\r\nOf 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.\r\n\r\nDISCUSSION\r\nDupilumab may be an effective treatment in children with EoE with prior STC use, or prior IRIC to STCs.","PeriodicalId":520099,"journal":{"name":"The American Journal of Gastroenterology","volume":"15 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"The American Journal of Gastroenterology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14309/ajg.0000000000003599","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.