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Dupilumab improves histologic, symptomatic, and endoscopic features of EoE regardless of concurrent FED: Post hoc LIBERTY analysis

IMMUNOLOGY & ALLERGY
30 May 2025

STUDY DESIGN

Eosinophilic esophagitis (EoE) is a chronic, progressive, type 2 inflammatory disease of the esophagus.1 While food elimination diets (FED) are an established treatment for EoE, their impact on the efficacy of medical therapy remains unclear.1 Dupilumab, approved in the United States and European Union for patients aged ≥1 year and weighing ≥15kg, offers a targeted treatment option.1 A post hoc analysis of the LIBERTY EoE TREET trial evaluated whether the efficacy of once-weekly (QW) dupilumab differs in adolescents and adults with or without concurrent FED.1 This post-hoc analysis included patients from parts B and B-C of the phase 3 LIBERTY EoE TREET trial.1 In part B, patients received dupilumab 300mg or placebo weekly until week 24 (W24), while those continuing into part C received dupilumab 300mg weekly until W52.1 At screening, 60 patients (38.0%) were following FED and were instructed to maintain it throughout the study.1 The key efficacy outcomes assessed, including histologic remission (≤6 eosinophils per high-power field [eos/hpf]) and absolute mean changes from baseline in Dysphagia Symptom Questionnaire (DSQ) score, Endoscopic Reference Score (EREFS), and EoE Histologic Scoring System (EoE-HSS) grade/stage, were analyzed based on concurrent FED status at W24 and W52.1

“Dupilumab QW improved histologic, symptomatic, and endoscopic features of EoE in adolescents and adults up to 24 weeks vs. placebo, irrespective of concurrent FED. Improvements were sustained up to 52 weeks"

Dr. Antonella Cianferoni

The Children’s Hospital of Philadelphia, Pennsylvania, United States

FINDINGS

Efficacy endpoints:

  • The efficacy outcomes assessed were the proportion of patients achieving  6 eos/hpf and absolute mean change from baseline in DSQ score, EREFS, and EoE-HSS grade/stage1

  • At week 24, dupilumab significantly improved all efficacy endpoints compared to placebo, regardless of concurrent FED status:

    • The proportion of patients achieving  6 eos/hpf with dupilumab vs. placebo was 61.3% vs. 3.4% (p<0.0001) with FED and 57.1% vs. 8.0% (p<0.0001) without FED1

    • DSQ score was improved with dupilumab vs. placebo by -26.25 vs. -18.27 with FED and -21.43 vs. -10.39 without FED (p<0.001)1

    • EREFS score was improved with dupilumab vs. placebo by -3.81 vs. 0.23 with FED and -4.82 vs. -1.14 without FED (p<0.0001 for both)1

    • EoE-HSS grade score was improved with dupilumab vs. placebo by -0.75 vs. -0.04 with FED and -0.87 vs. -0.20 without FED (p<0.0001 for both)1

    • EoE-HSS stage score was improved with dupilumab vs. placebo by -0.73 vs. -0.06 with FED and -0.85 vs. -0.16 without FED (p<0.0001 for both)1

    • At week 52, improvements in all EoE efficacy endpoints were maintained in patients continuing dupilumab, regardless of FED status. Patients who switched to dupilumab also demonstrated similar improvements1
Safety:
  • The safety data of dupilumab was consistent with its established safety profile1

 

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Dupilumab treatment in younger children with AD may improve lifelong growth outcomes

STUDY DESIGN 

A 2007-2008 assessment of atopic dermatitis (AD) severity and height revealed that adolescents with moderate to severe AD had significantly higher odds of having a height <25th percentile on Center for Disease Control (CDC) growth reference chart.1 In particular, children with AD and in the ≤25th height percentile have a greater risk of having low bone mineral density and alkaline phosphatase (ALP) levels.1 The underlying mechanisms of this phenomenon remain unclear but may be linked to chronic sleep disruption associated with AD, the use of oral and topical glucocorticoids, and the effects of prolonged inflammation.1

Dupilumab was previously shown to significantly increase the levels of bone ALP in serum compared to placebo in children aged 6 to 11 with moderate-to-severe AD enrolled in a phase 3 trial and it’s open-label extension (OLE) study.1 In the LIBERTY-AD PEDS trial, the proportion of children aged 6 to 11 years with severe AD and lower stature who reached a ≥5-percentile improvement in height following 16 weeks of treatment with dupilumab compared to those in the placebo group was reported.1

LIBERTY-AD PEDS was a double-blind, randomized, placebo-controlled study that enrolled 304 children aged 6 to 11 years with severe AD.1 Participants were randomized 1:1 to receive 300mg dupilumab every 4 weeks or placebo, in addition to mild or moderately potent topical corticosteroids.1 The height and weight of the participants were collected at baseline and at week 16 in a post-hoc analysis.1
DERMATOLOGY
08 Feb 2025