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ADOLESCENT STUDY DESIGN

In the treatment of adolescents (12-17 years) with uncontrolled
moderate-to-severe atopic dermatitis

DUPIXENT was studied in 1 pivotal trial

251 adolescent patients
studied 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

Adolescent (12-17 years of age)1,2
Number of
patients

251

Pivotal
trials

1 Monotherapy
(AD-1526)

Dosingb

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

Disease severity
at baseline
Moderate atopic
dermatitis (IGA 3)
Severe atopic
dermatitis (IGA 4)
46%
54%
Disease extent
at baseline
Mean EASI score
Mean body surface area involvement
36
out of 72
57%
Itch severity at baselined
Peak
Pruritus NRS
8
out of 10

aThese baseline characteristics are not meant for comparison.

bEmollient background regimen was required.2

cStudied vs placebo.

dWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).1

Primary endpoint in the adolescent clinical trial: 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 and a ≥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.

View PEAK PRURITUS NRS RESULTS View iga results View easi results View safety profile VIEW REAL-WORLD STUDIES IN ADULTS AND ADOLESCENTS VIEW AD WITH HAND AND/OR FOOT INVOLVEMENT DATA (AGES 12+ YEARS)

Dosage and administration

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