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
Patient 2: 4-year-old achieved a 3-point improvement in IGA
Patient 3: 3-year-old achieved a 2-point improvement in IGA
Patient 4: 2-year-old achieved a 2-point improvement in IGA
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 IN AD-1539
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
IGA assesses the overall severity of the clinical signs of atopic dermatitis2
A 0- to 4-point scoring system of the overall severity of atopic dermatitis skin lesions2
Severe erythema and severe
Moderate erythema and moderate
Mild erythema and mild
Just perceptible erythema, and
just perceptible papulation/infiltration
No inflammatory signs of atopic dermatitis
A clinical responder
was defined as a
patient achieving IGA 0
or 1 and at least a
IGA, Investigator's Global Assessment.
Example representation of IGA scoring.
Not an actual patient.