Significant Skin Clearance

A total of 367 children (6-11 years of age) in Trial 8 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. This study compared both weight-tiered and non-weight-tiered dosing regimens. From these results, the recommended dosing for children aged 6-11 years is as follows: Patients ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose. An endpoint included the change from baseline in the proportion of subjects with EASI-75 at Week 16.1,2

Long-lasting Skin Clearance

6-11 years

At least 75% improvement in lesion extent and severity (EASI-75) with DUPIXENT + TCS at Week 16 in Trial 8 (secondary endpoint)1,2,a,b

  1. Full Analysis Set 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.
  3. At Day 1, subjects (baseline weight <30 kg) received 600 mg of DUPIXENT.
  4. At Day 1, subjects (baseline weight ≥30 kg) received 400 mg of DUPIXENT.

Measuring Disease Extent and Severity and Patient-Reported Eczema Symptoms

EASI combines the severity of the signs of eczema and the extent of skin involvement.2

The severity of each of 4 eczema signs is assessed on a scale of 0 to 34

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.3,4

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.3,4

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. 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.
  4. EASI User Guide. HOME–Harmonising Outcome Measures for Eczema. Accessed March 11, 2020. www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf.