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Dupilumab Improves Endoscopic Features in Children Aged 1-11 Years With Eosinophilic Esophagitis: EoE KIDS Study
Shauna Schroeder1, Mirna Chehade2, Calies Menard-Katcher3,4
1Division of Gastroenterology, Hepatology, and Nutrition, Phoenix Children's Hospital, Phoenix, Arizona, USA.
Insights
Dupilumab significantly improved endoscopic features of eosinophilic esophagitis (EoE) in children within 16 weeks. Continuous treatment for 52 weeks led to higher rates of endoscopic normalization compared to switching to dupilumab later.
Area of Science:
- Gastroenterology
- Pediatric Gastroenterology
- Immunodermatology
Background:
- Eosinophilic esophagitis (EoE) is a chronic immune-mediated esophageal disease.
- Endoscopic evaluation is crucial for assessing EoE severity and treatment response.
- The Endoscopic Reference Score (EREFS) quantifies esophageal inflammation and fibrostenosis.
Purpose of the Study:
- To evaluate the impact of dupilumab on endoscopic features of EoE in children aged 1-11 years.
- To assess changes in EREFS scores, including total, inflammation, and fibrostenosis subscores.
- To determine the proportion of patients achieving endoscopic normalization with dupilumab treatment.
Main Methods:
- Post hoc analysis of the phase 3 EoE KIDS trial.
- Patients received weight-tiered higher-exposure (HE) dupilumab or placebo for 16 weeks, followed by an additional 36 weeks of dupilumab.
- EREFS scores and endoscopic normalization rates were assessed at Weeks 16 and 52.
Main Results:
- Dupilumab significantly reduced EREFS total and inflammation subscores at Week 16 compared to placebo.
- Improvements in fibrostenosis features were limited, potentially due to low baseline scores.
- Continuous dupilumab treatment for 52 weeks resulted in a higher rate of endoscopic normalization (30.3%) versus switching at Week 16 (12.5%).
Conclusions:
- Dupilumab effectively improves endoscopic features of EoE in children.
- Treatment benefits are sustained up to 52 weeks.
- Continuous dupilumab therapy maximizes the likelihood of achieving endoscopic normalization in pediatric EoE patients.
Introduction:
This post hoc analysis assessed the impact of dupilumab on endoscopic features of eosinophilic esophagitis (EoE) using the Endoscopic Reference Score (EREFS) in children 1-11 years of age in the phase 3 EoE KIDS trial.
Methods:
Patients who received weight-tiered higher-exposure (HE) dupilumab (N = 37) or placebo (N = 34) for 16 weeks (part A) and weight-tiered HE dupilumab for 36 additional weeks (N = 55) (part B) in EoE KIDS were included. Change from baseline in EREFS total score, EREFS inflammation and fibrostenotic subscores, component scores, and proportion of patients achieving endoscopic normalization (EREFS total score of 0), were assessed at week 16 and week 52.
Results:
At week 16, EREFS total score and inflammation subscore were reduced with dupilumab vs placebo (least squares mean difference -66.9% [95% CI -89.8 to -44.0] and -2.2% [-2.7 to -1.8], respectively); improvements in features of fibrostenosis were limited (-0.2% [-0.5 to 0.1]), partly because of low baseline scores in these features. At week 52, outcomes were maintained or further improved in patients continuing dupilumab and improved in placebo patients who switched to dupilumab at week 16. Continuous dupilumab treatment for 52 weeks led to a greater proportion of patients in endoscopic normalization vs switching to dupilumab at week 16 (30.3% vs 12.5%).
Discussion:
Dupilumab improved endoscopic features of EoE at week 16 vs placebo, and improvements were sustained up to 52 weeks. A greater proportion of patients treated with continuous dupilumab achieved endoscopic normalization at week 52 compared with those who switched to dupilumab at week 16.
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