Visible Results

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. The primary endpoint was the change from baseline to Week 16 in the proportion of subjects with an Investigator's Global Assessment (IGA) of 0 (clear) or 1 (almost clear) and ≥2-point improvement.1,2

Significant skin clearance was demonstrated in adolescents (primary endpoint; P<0.001)1-3,a

Efficacy Results of DUPIXENT
at Week 16 (FAS)
DUPIXENT
(n=82)
PLACEBO
(n=85)
Achieved
clear or
almost‑
clear skin
(IGA 0 or 1)
24% 2%
  • a Responder 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).

Visible Results in an Adolescent Patient

Adolescent patient achieved a 2-point improvement in IGA

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Actual 12-year-old patient in the phase 3 adolescent DUPIXENT trial. Patient had a baseline IGA of 4 and EASI of 31. Individual results may vary.

A clinical responder was defined as a patient achieving IGA 0 or 1 and at least a 2-point
improvement from baseline1

  • This adolescent patient would not have met the primary endpoint in the clinical trials based on their IGA score at Week 16
See Changes in Adults Not Achieving
IGA 0 or 1

See Changes in Children (6 to 11 Years)
  • BSA, body surface area.
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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. 2019;80(1):158-167.
  3. Data on file, Regeneron Pharmaceuticals, Inc.