Evaluated in 251 adolescent patients (12-17 years) in AD-15261
Clinical trials in adolescents included 1 monotherapy trial (AD-1526) and 1 open-label extension trial (AD-1434). In AD-1526, patients were initiated with 2 DUPIXENT (200 mg or 300 mg) doses or placebo (subcutaneous injection) at Week 0 followed by 1 DUPIXENT (200 mg or 300 mg) dose or placebo every 2 weeks, based on the adolescent’s weight.1
Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1,a
(12-17 years of age)1,2
For patients <60 kg, a loading dose of 400 mg (2 x 200 mg SC injections) followed by 200 mg (1 SC injection) Q2W or for patients ≥60 kg, a loading dose of 600 mg (2 x 300 mg SC injections) followed by 300 mg (1 SC injection) Q2Wc
out of 72
out of 10
aThese baseline characteristics are not meant for comparison.
bEmollient background regimen was required.3
cStudied vs placebo.
dWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).
Primary endpoint in the adolescent clinical trial: Change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement 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; SC, subcutaneous.