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 dose1,2

DUPIXENT was evaluated in adolescent patients whose moderate-to-severe atopic dermatitis was inadequately controlled on topical Rx therapies.1-3

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)
46%
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).

Dosing and
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References:
  1. DUPIXENT Prescribing Information.
  2. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56.
  3. Data on file, Regeneron Pharmaceuticals, Inc.