Visible Results

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. 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).1,2

Significantly Clearer Skin in Children

6-11 years

Significant improvement with DUPIXENT demonstrated at Week 16 (primary 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.

Visible Results in Children

Actual patients in a Phase 3 pediatric DUPIXENT trial (Trial 8). All patients were prescribed concomitant TCS based on the clinical trial program. Patients 1, 2, and 3 were considered clinical responders. Individual results may vary.

6-year-old (Patient 1) achieved a 3-point improvement in IGA

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10-year-old (Patient 2) achieved a 3-point improvement in IGA

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9-year-old (Patient 3) achieved a 3-point improvement in IGA

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6-year-old (Patient 4) achieved a 1-point improvement in IGA

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A clinical responder was defined as a patient achieving IGA 0 or 1

See Changes in Adults Not Achieving IGA 0 or 1
See Changes in Adolescents (12 to 17 Years) Not Achieving IGA 0 or 1
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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.