(6-11 years of age)1-3,a
DUPIXENT + TCS vs
placebo + TCS (AD-1652)
For patients 15 kg to <30 kg, a loading dose of 600 mg (2 x 300 mg SC injections) followed by 300 mg (1 SC injection) Q4W or for patients ≥30 kg to <60 kg, a loading dose of 400 mg (2 x 200 mg SC injections) followed by 200 mg (1 SC injection) Q2Wd
out of 72
out of 10
aThese baseline characteristics are not meant for comparison.
bAt baseline, mean disease duration was ≈7 years. Mean age was 8.5 years.
cEmollient background regimen was required. The study design tested both weight-tiered and non–weight-tiered dosing. Based on results, the approved dosing was weight tiered.
dStudied vs placebo.
eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).
Primary endpoint in the study with children was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16.1
Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%) and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16.1
EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SC, subcutaneous; TCS, topical corticosteroids.