Dupilumab is a fully human monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL-13. Researchers assessed the effect of dupilumab on the severity, signs, symptoms, and quality of life in adolescent patients with moderate-to-severe atopic dermatitis (AD) and found that this treatment showed significant and clinically meaningful benefit in all measures studied. The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020.
The study included 251 patients from the randomized, double-blind, placebo-controlled LIBERTY AD ADOL study, which included patients aged 12 to 17 years who were randomized 1:1:1 to receive dupilumab 300 mg subcutaneously (SC) every four weeks, dupilumab 200-300 mg SC every two weeks, or placebo. In the current study, 84, 82, and 85 patients received each treatment option, respectively. Baseline characteristics were similar among the three cohorts.
At week 16, significantly more patients treated with dupilumab showed greater improvement in Eczema Area and Severity Index (EASI) compared with placebo: EASI-50 was 61% in the dupilumab two-week dosing cohort, 54.8% in the dupilumab four-week dosing cohort, and 12.9% in the placebo cohort (P<0.0001). EASI-75 was 41.5%, 38.1%, and 8.2%, respectively (P<0.0001), and EASI-90 was 23.2%, 19.0%, and 2.4%, respectively (P<0.001).
At week 16, significantly more patients treated with dupilumab achieved a ≥6-point improvement in Patient-Oriented Eczema Measure (63.4% and 46.4% in the dupilumab two- and four-week dosing cohorts vs. 9.5% in the placebo group; P<0.0001) and Children’s Dermatology Life Quality Index (60.6% and 59.2% vs. 19.7%, respectively; P<0.0001).
Significantly more patients treated with dupilumab achieved a ≥3-point improvement from baseline in Peak Pruritus Numerical Rating Scale compared with placebo (48.8% and 38.6% vs. 9.4%; P<0.0001). Dupilumab also induced significant improvement in body surface area affected by AD compared with placebo (−30.11 and −33.41 vs. −11.66; P<0.0001).
Treatment-related adverse events (AEs) were reported in in 59 patients (72.0%) in the dupilumab two-week dosing cohort, 53 (63.9%) in the dupilumab four-week dosing cohort, and 59 (69.4%) in the placebo group. Only one AE resulted in treatment discontinuation, which was in the placebo group. Exacerbations of AD, skin infections, and upper respiratory tract infections were common AEs in the placebo group, while conjunctivitis and injection-site reaction were more common with dupilumab treatment.Eichenfield LF, Silverberg JI, Gadkar A, et al. Dupilumab Improves Signs, Symptoms, and Quality of Life in Adolescents With Moderate-to-Severe Atopic Dermatitis. Presented during the AAD Virtual Meeting Experience 2020, June 12-14, 2020.