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
