The P-III trial evaluating Dupixent (SC, high/low dose regimen) vs PBO in young children aged 1-11yrs. with EoE
The results showed that 68% in high dose & 58% in low dose achieved histological disease remission vs 3% @16wk., improvements in abnormal endoscopic findings of their esophagus in children with the higher dose regimen with a reduction of 3.5 vs 0.3 points, improvement in the proportion of days children experienced disease symptoms but not significant
In a prespecified exploratory analysis, a high dose led to a 3.09% vs 0.29% increase in body weight, safety results were consistent with the known safety profile of Dupixent in its approved EoE, AEs rate (79% vs 91%), AEs leads to treatment discontinuation before 16wk. (0% vs 6%)
Ref: PRNewswire | Image: Regeneron
