For a study, it was determined that for teenagers with moderate-to-severe illness, atopic dermatitis was a chronic inflammatory disorder with a significant burden and few therapeutic choices. Significantly more individuals who received dupilumab compared to placebo obtained Investigator’s Global Assessment 0/1. Researchers wanted to determine how dupilumab therapy compared to placebo affected clinically relevant improvements in atopic dermatitis signs, symptoms, and quality of life.
The phase III clinical trial R668-AD-1526 LIBERTY AD ADOL was a randomized, double-blind, parallel-group study. Dupilumab 300 mg every 4 weeks (q4w; n=84), dupilumab 200 or 300 mg every 2 weeks (q2w; n=82), or placebo (n=85) were administered to 251 adolescents with moderate-to-severe atopic dermatitis. At week 16,214 patients with Investigator’s Global Assessment, more than one underwent a post-hoc subgroup analysis. Atopic dermatitis signs, symptoms, and quality of life were evaluated. A clinically meaningful improvement in one or more of three domains of signs, symptoms, and quality of life was defined as a 50% improvement from baseline in the Eczema Area and Severity Index, a 3 point improvement in the Peak Pruritus Numerical Rating Scale, or a 6 point improvement in the Children’s Dermatology Life Quality Index.
At week 16, 80.5% [66/82] of patients receiving dupilumab q2w experienced clinically meaningful improvements in atopic dermatitis signs, symptoms, or quality of life (vs. placebo, 20/85 [23.5%], difference 57.0% [95% CI 44.5–69.4]; q4w vs. placebo, 53/84 [63.1%], difference 39.6% [95%CI 25.9–53.3]; both. At week 16, the results were comparable in adolescents with Investigator’s Global Assessment more than one (q2w, 46/62 [74.2%] vs. placebo, 18/83 [21.7%], difference 52.5% [95% CI 38.5–66.6]; q4w, 38/69 [55.1%] vs. placebo, difference 33.4% [95% CI 18.7–48.1]; both p<0.0001).
Dupilumab demonstrated clinically significant improvements in signs, symptoms, and quality of life in adolescents with moderate-to-severe atopic dermatitis who had an Investigator’s Global Assessment of 1 or above. Such clinically meaningful patient-reported outcome indicators should be used to interpret treatment responses.
Reference:link.springer.com/article/10.1007/s40257-019-00478-y
