Evaluated in 367 children (6-11 years of age) in AD-16521

Clinical trials in children included 1 trial with concomitant TCS (AD-1652) and 1 open-label extension trial (AD-1434). In AD-1652, 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 or 4 weeks, based on the child’s weight.1

Disease severity was defined by an IGA score of ≥4 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥21 on a scale of 0 to 72, and a minimum body surface area involvement of ≥15%.1

Children
(6-11 years of age)1-3,a
Number of
patients

367

Pivotal
trialsb

1 double-blind
DUPIXENT + TCS vs
placebo + TCS (AD-1652)

Dosingc

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

Disease severity at baseline
Severe atopic dermatitis
(IGA 4)

100%

Disease extent at baseline
Mean EASI score
Mean body surface
area involvement
38
out of 72

58%

Itch severity at baselinee
Peak Pruritus NRS
7.8
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.

See IGA Results

See EASI Results

See Peak Pruritus NRS Results

See safety profile