A total of 251 adolescents in Trial 6 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W after a 600 mg loading dose, and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose.1,2
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
Primary endpoint in the adolescent clinical trial: Change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement1
|Adolescent (12-17 years of age)1|
|Number of patients||251|
|Pivotal trials||1 Monotherapy (Trial 6)|
|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)||54%|
|Disease extent at baseline
Mean EASI score
|36 out of 72|
|Mean body surface area involvement||57%|
|Itch severity at baselined
Peak Pruritus NRS
|8 out of 10|
Adolescent clinical trials included 1 monotherapy trial (Trial 6) and 1 open-label extension trial (Trial 7); both trials initiated with
2 DUPIXENT (200 mg or 300 mg) or placebo subcutaneous injections at Week 0 based on the adolescent’s weight. Emollient background regimen was required.1,3
EASI, Eczema Area and Severity Index: IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; SC, subcutaneous; TCS, topical corticosteroids.
aThese baseline characteristics are not meant for comparison.
bEmollient background regimen was required.
cStudied vs placebo.
dWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).