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

Background

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.

Aims

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

Methods

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.

Results

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.

Conclusions

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.

Funding Agencies

Research sponsored by Sanofi and Regeneron Pharmaceuticals Inc.