Significant Skin Clearance

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, while adolescents <60 kg received 200 mg Q2W following a 400 mg loading dose. An endpoint included the change from baseline in the proportion of subjects with EASI‑75 at Week 16.1,2

Significant Skin Clearance

12-17 years

At least 75% improvement in lesion extent and severity (EASI‑75) at Week 16 with DUPIXENT in Trial 6 (secondary endpoint)1-3,a,b

Significant skin clearance was demonstrated in adolescents (primary endpoint)1-3,c

  • 24% of DUPIXENT patients achieved clear or almost‑clear skin (IGA 0 or 1) vs 2% with placebo at Week 16 in Trial 6 (primary endpoint; P<0.001).
  1. FAS includes all subjects randomized.
  2. In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders (59% and 21% in the placebo and DUPIXENT arms, respectively).
  3. 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 IGA scale at Week 16 (primary efficacy outcome).

Measuring Disease Extent and Severity and Patient‑Reported Symptoms

EASI combines the severity of the signs of eczema and the extent of skin involvement.4

The severity of each of 4 eczema signs is assessed on a scale of 0 to 35

The extent of lesions in each body region is evaluated based on the percentage of involvement and is given a value between 0 and 6. Each body region value is then weighted by a corresponding multiplier; lower extremities are weighted more while head and neck are weighted the least.4,5

Each region gets a total region score: Severity Score x Area Score x Multiplier = Region Score

The final EASI score is the sum of all 4 region scores. The composite score, on a scale from 0 to 72 determines the severity of the signs of eczema and the extent to which the patient is affected.4,5

An improvement of at least 75% in lesion extent and severity (EASI‑75) from baseline is a clinically meaningful change.1

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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  3. 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.
  4. Leshem YA. Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015:172(5):1353-1357.
  5. EASI User Guide. HOME-Harmonising Outcome Measures for Eczema. Accessed March 11, 2020. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf.