A145 EFFECT OF DUPILUMAB ON WEIGHT IN PATIENTS AGED 1 TO 11 YEARS WITH ACTIVE EOSINOPHILIC ESOPHAGITIS (EOE): RESULTS FROM THE PHASE 3 EOE KIDS STUDY

TL;DR

Dupilumab treatment in children with EoE led to greater weight gain compared to placebo over 16 and 52 weeks.

Contribution

This study is the first to show dupilumab's impact on weight in children with EoE in a phase 3 trial.

Findings

At Week 16, dupilumab increased weight-for-age percentile more than placebo.

Improvements in BMI and weight z-scores were sustained at Week 52.

Switching from placebo to dupilumab also showed weight benefits.

Abstract

During the phase 3 eosinophilic esophagitis (EoE) KIDS study (NCT04394351), dupilumab improved histologic and endoscopic endpoints and quality of life vs placebo in children aged 1 to 11 years with active EoE.

This analysis assessed the effect of higher-exposure dupilumab vs placebo on weight in children with EoE enrolled in the KIDS study.

Part A was a 16-week, double-blind treatment period; patients were randomized to receive weight-tiered dupilumab or placebo. Patients who completed Part A were eligible to enter a 36-week, extended treatment period (Part B) in which dupilumab patients continued the same dupilumab regimen and placebo patients switched to pre-assigned dupilumab. Outcomes at Weeks 16 and 52 included mean absolute and percent change from baseline in: body weight-for-age percentile, body mass index (BMI)-for-age z-score for patients aged ≥2 years, weight-for-age z-score, and weight-for-length z-score.

At Week 16, mean percent changes (standard deviation) from Part A baseline for higher-exposure dupilumab vs placebo were +3.09 (+21%) vs +0.29 (+5%) in body weight-for-age percentile; +0.10 (+27%) vs -0.14 (+6%) in BMI-for-age z-score, and +0.12 (-20%) vs -0.01 (-1%) in weight-for-age z-score. At Week 52, improvements were maintained or increased with continued higher-exposure dupilumab; improvements were also observed in placebo patients who switched to higher-exposure dupilumab (Table). Dupilumab safety was consistent with its known safety profile.

Higher-exposure dupilumab was associated with a greater increase vs placebo in body weight-for age percentile at Weeks 16 and 52, and sustained trends for increased BMI-for-age and weight-for-age z-scores, in children with EoE aged 1 to 11 years.

Table. Effect of higher-exposure dupilumab on outcomes associated with weight increases at Weeks 16 and 52

Data are mean (standard deviation). n=number of patients at each visit. aPart A full analysis set. bPart B safety analysis set. cn=8.

BMI, body mass index.

Research sponsored by Sanofi and Regeneron Pharmaceuticals Inc.

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