A total of 251 adolescent patients in Trial 6 (16-week trial) with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W following a 600 mg loading dose, while adolescents <60 kg received 200 mg Q2W following a 400 mg loading dose.1
|Adolescent (12-17 years of age)1|
|Number of patients||251|
|Pivotal trialsb||1 Monotherapy (Trial 6)|
|Dosagec||For patients <60-kg an initial dose of 400 mg followed by 200 mg Q2W or for patients ≥60 kg an initial dose of 600 mg followed by 300 mg Q2Wd|
|Mean disease duration (years)||≈12|
|Mean age (years)||14.5|
|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 baselinee
Peak Pruritus NRS
|8 out of 10|
Adolescent clinical trials included 1 monotherapy trial (Trial 6) and 1 open-label extension trial (Trial 7); all trials initiated with two 200 mg DUPIXENT or placebo subcutaneous injections at Week 0, and emollient background regimen was required.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
Primary endpoint across all 3 adult pivotal trials: 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
EASI, Eczema Area and Severity Index: IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.
aThese baseline characteristics are not meant for comparison.
bTrial 4 was a dose-ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. Trial 5 evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.
cEmollient background regimen was required.
dStudied vs placebo.
eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).