522 - Efficacy and safety of abrocitinib in combination with topical therapy in adolescents from China with moderate-to-severe atopic dermatitis: A post hoc analysis of the JADE TEEN phase 3 trial

Abstract

Abstract Background Atopic dermatitis (AD) has a reported prevalence of 3% in adolescents aged 13-14 years in China. However, studies evaluating the efficacy and safety of Janus kinase 1-selective inhibitors in AD in patients from China are limited. Abrocitinib is an oral, once-daily, Janus kinase 1–selective inhibitor approved for the treatment of moderate-to-severe AD in adults and adolescents in the United States and in adults in China. The efficacy of abrocitinib as monotherapy or in combination with medicated topical therapy has been demonstrated in multiple phase 3 clinical trials in adolescent and adult patients with moderate-to-severe AD. In a separate phase 3 trial of adolescent patients (JADE TEEN [NCT03796676]), abrocitinib administered in combination with medicated topical therapy was effective in improving the signs and symptoms of moderate-to-severe AD, with an acceptable safety profile. JADE TEEN was conducted in several countries, including China. Objective To assess the efficacy and safety of abrocitinib in combination with topical therapy in Chinese adolescents with moderate-to-severe AD enrolled in JADE TEEN. Methods In JADE TEEN, adolescent patients (aged 12 to 17 years) were randomly assigned (1:1:1) to receive abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 weeks in combination with medicated topical therapy. This post hoc analysis included data from patients enrolled in JADE TEEN from mainland China. Assessments included the proportion of patients at week 12 who achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline, ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75), and ≥4 point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS4; used with permission from Regeneron Pharmaceuticals, Inc., and Sanofi). Change from baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) total score at week 12 was also assessed. Safety was assessed by treatment emergent adverse event (TEAE) monitoring. Results Of 285 patients enrolled in JADE TEEN, 52 (18.2%) were enrolled from mainland China and consisted of 14, 18, and 20 patients who were randomly assigned to receive abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Median age at baseline was 15.0 years (interquartile range [IQR], 14.0-17.0 years), and median duration since onset of AD was 9.8 (IQR, 4.4-13.7) years. At week 12, a higher proportion of patients treated with abrocitinib at either dose compared with placebo achieved efficacy responses of IGA 0/1 (abrocitinib 200 mg, 46.2%; abrocitinib 100 mg, 46.7%; placebo, 22.2%), EASI-75 (69.2%; 73.3%; 27.8%), and PP-NRS4 (63.6%; 50.0%; 20.0%). Decreases from baseline in PSAAD total score were greater in patients treated with abrocitinib at either dose compared to placebo at week 12 (abrocitinib 200 mg, −3.4; abrocitinib 100 mg, −3.2; placebo, −1.8). Response rates were largely comparable between patients from China and the overall JADE TEEN study population, although CIs were wider in the China subgroup because of the small sample size. In the China subgroup, TEAEs were experienced by 13 (92.9%), 16 (88.9%), and 15 (75.0%) patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo groups, respectively. Compared to the overall population, there were no new safety signals identified in patients from China. Conclusions Abrocitinib administered in combination with medicated topical therapy was effective and well tolerated in adolescent patients from China with moderate-to-severe AD. Efficacy and safety findings were consistent with the overall JADE TEEN population.