A multicenter, prospective, real-world study found that dupilumab was safe and effective for the treatment of moderate to severe atopic dermatitis (AD) among adolescents aged 12 to 17 years. These findings were published in the Journal of The European Academy of Dermatology and Venerology.
Prospective data were collected for this study from adolescents (N=139) with AD receiving dupilumab treatment, dosed according to body weight, at 30 referral centers in Italy from December 2020 to February 2021. Treatment efficacy was evaluated using Eczema Area and Severity Index (EASI), numeric rating scale (NRS) itch, NRS sleep loss score, and Children Dermatology Life Quality Index (CDLQI).
The study cohort comprised 54.0% boys, aged mean 15.1 (range, 12-17) years, and 74.6% had serum total immunoglobulin (Ig)E levels above the normal range. The most common symptoms were flexural eczema (84.9%), head and neck eczema (84.2%), hand eczema (49.6%), and portrait-like dermatitis (20.1%). The patients had previously taken antihistamines (90.7%), corticosteroids (77.7%), cyclosporine A (38.9%), phototherapy (20.1%), and methotrexate (0.7%).
At week 16, EASI scores had decreased by 79.8% (mean, 26.2 vs 5.3; P <.01), CDLQI scores by 72.9% (mean, 14.4 vs 3.9; P <.01), NRS sleep loss scores by 75.8% (mean, 6.6 vs 1.6; P <.01), and NRS itch scores by 64.6% (mean, 8.2 vs 2.9; P <.01). Among patients with high baseline IgE, 93.2% had a mean reduction of serum IgE from 2215.9 KU/ml to 1329.3 KU/ml by week 16.
EASI improvement of 50% or greater was achieved by 99.3%, 75% or greater by 64.3%, 90% or greater by 33.3%, and 100% by 15.9%. Stratified by EASI improvement, more girls achieved EASI-75 than boys (P <.05). No other trends were observed by the investigators on the basis of EASI improvement.
Adverse events occurred among 20.1% of patients, in which 10.8% had conjunctivitis, 3.6% had flushing, 2.9% injection-site reaction, 1.4% fatigue, 1.4% diarrhea, 0.7% headache, and 0.7% herpes simplex. No patient discontinued treatment.
The major limitation of this study was that 28.1% of study participants continued to use concomitant systemic therapy during the first 3 to 4 weeks of the trial, which may have affected the observed outcomes.
This real-world, prospective study conducted during the COVID-19 pandemic found that dupilumab was effective at treating AD among adolescents and had an acceptable safety profile.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Stingeni L, Bianchi L, Antonelli E, et al. Moderate to severe atopic dermatitis in adolescents treated with dupilumab: a multicenter Italian real-world experience.J Eur Acad Dermatol Venereol. Published online April 12, 2022. doi:10.1111/jdv.18141