Visible results with DUPIXENT
In DUPIXENT clinical trials including infants to preschoolers, the primary endpoint was the proportion of subjects with an Investigator’s Global Assessment (IGA) of 0 (clear) or 1 (almost clear) at week 16.1
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.1
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 11
- 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
5 YEARS OF AGE
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.1
bIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1
