Expanding the Largest
Clinical Development
Program in Atopic Dermatitis
With an Adolescent (12 to 17
Years) Patient Trial

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

DUPIXENT was evaluated in adolescent patients whose moderate-to-severe atopic dermatitis was inadequately controlled on topical Rx therapies1-3

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).

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  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.