Clearer skin after the first dose (as measured at Week 2) in infants to preschoolers
≥75% improvement in lesion extent and severity (EASI-75) at Week 16 in AD-1539 (secondary endpoint)1,2,a,b
Definitive conslusion 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.
Measuring the extent and severity of lesional signs of atopic dermatitis
EASI combines the severity of the signs of eczema and the extent of skin involvement.3
THE SEVERITY OF EACH OF 4 ECZEMA SIGNS IS ASSESSED ON A SCALE OF 0 TO 33
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,c
An improvement of at least 75% in lesion extent and severity (EASI-75) from baseline is a clinically meaningful change.1
c In patients <8 years of age, the multipliers for the head and neck are 0.2, the trunk is 0.3, the upper extremities are 0.2, and the lower extremities are 0.3.
In patients ≥8 years of age, the multipliers for the head and neck are 0.1, the trunk is 0.3, the upper extremities are 0.2, and the lower extremities are 0.4.