Percentage of patients achieving
≥4-point reduction in Peak Pruritus NRS
Improvement seen as early as WEEK 4
(22% vs 5%)
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 two 300 mg loading doses, while adolescents <60 kg received 200 mg Q2W following two 200 mg loading doses. Eligible patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and body surface area involvement of ≥10%. At baseline, 46% had an IGA score of 3 (moderate atopic dermatitis), 54% had an IGA of 4 (severe atopic dermatitis), mean EASI score was 36, and weekly averaged Peak Pruritus NRS was 8 on a scale of 0 to 10.1 In adolescent patients, 92% had at least one comorbid allergic condition such as allergic rhinitis, asthma, or food allergy1. The safety and efficacy of DUPIXENT have not been established in the treatment of allergic rhinitis or food allergy.
The primary endpoint was the change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (24% of patients treated with DUPIXENT vs 2% with placebo in Trial 6, P<0.0001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 42% of patients treated with DUPIXENT vs 8% with placebo in Trial 6, P<0.0001) and reduction in itch as defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (37% of patients treated with DUPIXENT vs 5% with placebo in Trial 6, P<0.0001).1
Significant itch reduction (Peak Pruritus NRS) at Week 16 with DUPIXENT in Trial 6 (secondary endpoint)1,2,a,b
At least 75% improvement in lesion extent and severity (EASI-75) at Week 16 with DUPIXENT in Trial 6 (secondary endpoint)1,2,a
Efficacy Results of DUPIXENT
at Week 16 (FAS)
|Achieved clear or almost-clear skin (IGA 0 or 1)||24%||2%|
aFAS includes all subjects randomized.
bSubjects who received rescue treatment or with missing data were considered nonresponders (59% and 21% in the placebo and DUPIXENT arms, respectively).
cResponder was defined as a subject with an IGA 0 or 1 (clear or almost clear) and a reduction of ≥2-points on a 0-4 scale at Week 16 (primary efficacy outcome).
The safety profile of DUPIXENT at Week 52 was similar to the safety profile observed at Week 16 in Trial 6 (adolescent trial) and in all 3 adult trials. The long-term safety profile in adolescents was consistent with that seen in adults.1