Effectiveness and safety of age-based dosing of abrocitinib in children and adolescents with moderate to severe atopic dermatitis: A two-center, prospective real-world study in China.

Abrocitinib have been approved for patients with moderate to severe atopic dermatitis (AD), but its effectiveness and safety in adolescents, especially children is not established in both clinical trial and real-world studies. We aimed to analyze real-world data of abrocitinib in the treatment of children and adolescents. We prospectively enrolled children and adolescents with moderate to severe AD from 2 centers, who were stratified based on age groups (<6 years, 6-11 years, 12-17 years) and treated with oral abrocitinib at dosages of 25, 50, or 100 mg daily accordingly. The study assessed various parameters, including the eczema area and severity index (EASI), scoring of atopic dermatitis, investigator's global assessment, numerical rating scale-itch, sleep-loss scores, children dermatology quality of life index/dermatology quality of life index, and safety at baseline and at weeks 2, 4, and 12 of treatment. This study included 28 children and adolescents with moderate to severe AD (4 patients aged < 6 years, 9 aged 6-11 years, and 15 aged 12-17 years). All patients combined exhibited a rapid and significant improvement in the clinical signs and symptoms of AD following the initial follow-up visit. By week 12, EASI-50, EASI-75, and EASI-90 responses were achieved by 100%, 60.7%, and 25.0% of all patients combined, respectively. 57.2% of all patients combined achieved investigator's global assessment 0/1, and 85.7% had a reduction in numerical rating scale-itch score of at least 4 points. The sleep-loss score and children dermatology quality of life index/dermatology quality of life index score were reduced by 78.8% and 78.5% of all patients combined, respectively. Similar trends in the data were observed across various age groups, including patients aged < 6 years, 6-11 years, and 12-17 years. Two adolescents (7.1%) experienced mild adverse events, including Kaposi's varicelliform eruption and nausea, with no occurrence of serious adverse events throughout the treatment period. The real-world application of age-based dosing of abrocitinib revealed favorable efficacy and well-tolerated safety profiles in treating moderate to severe AD among children and adolescents.