Visible results with DUPIXENT

In DUPIXENT clinical trials including infants to preschoolers, 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).
Actual patients in a Phase 3 DUPIXENT trial (AD-1539) in infants to preschoolers (aged 6 months to 5 years). Patients were prescribed concomitant low-potency TCS based on the clinical trial program. Patients 1, 2, and 3 were considered clinical responders. Individual results may vary.

Patient 1: 4-year-old achieved a 2-point improvement in IGA

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Patient 2: 4-year-old achieved a 3-point improvement in IGA

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Patient 3: 3-year-old achieved a 2-point improvement in IGA

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Patient 4: 2-year-old achieved a 2-point improvement in IGA

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

  • Patient 4 did not meet the primary endpoint in the clinical trial based on their IGA score at Week 16

Clearer skin demonstrated in infants to preschoolers

6 MONTHS TO
5 YEARS OF AGE
Skin clearance at Week 16 (primary endpoint)1,2,a,b

Definitive conclusions cannot be made for time points earlier than Week 16 as those data were not multiplicity-controlled and P value was nominal.

aFull Analysis Set includes all subjects randomized.

bIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.