Regeneron & Sanofi Report P-III Trial Results of Dupixent (dupilumab) for Eosinophilic Esophagitis in Children Aged 1 to 11 Years
Shots:
- The P-III trial evaluates Dupixent (high/low dose) vs PBO in 102 children aged 1 to 11yrs. with EoE
- The trial met its 1EPs of histological disease remission @16wks., 68% & 58% of children in a high & low dose. In high dose, 86% vs 21% reduction in peak esophageal intraepithelial eosinophil count from baseline; 0.88 & 0.84 vs 0.02 & 0.05 in disease severity & extent; 3.5 vs 0.3 point in abnormal endoscopic, improvement in the proportion of days & children experienced symptoms of EoE but not statistically significant
- The lower dose group's 2EPs were equivalent to the higher dose. The safety results were consistent with the safety profile of Dupixent in children & adults aged ≥12yrs., AEs (79% vs 91%) & treatment discontinuation due to AEs (0% vs 6%) @16wk.
Ref: PRNewswire | Image: Sanofi
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