Abrocitinib extends its indication for the treatment of moderate-to-severe AD in teenagers

Abrocitinib is an oral selective Janus kinase (JAK) 1 inhibitor which modulates the function of key cytokines involved in the pathogenesis of atopic dermatitis (AD) and has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of moderate-to-severe AD in adults.1 In February 2023, the drug received supplementary approval from the FDA to extend its indication to include adolescent patients aged 12 to <18, following the positive results of the JADE TEEN trial, a phase 3 randomized, placebo-controlled, parallel-group study.2  

Around 20% of children and adolescents around the world suffer from AD.3 The chronic, relapsing inflammatory condition is reported to have the highest disability-adjusted life-years burden among all skin diseases.3 When compared with adults, adolescents suffering from AD are more likely to be affected by psychosocial and mental health problems, including sleep disturbance, depression, and anxiety, leading to interference with interpersonal relationships and physical activities.1,3 Young patients with uncontrolled moderate-to-severe AD are therefore in urgent need of an efficacious systemic therapy for stabilizing their conditions.1 An oral treatment is believed to be able to provide a more favorable benefit-risk profile for adolescents.1

JADE TEEN is a phase 3, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of oral abrocitinib added to topical therapy in adolescents with moderate-to-severe AD.1 A total of 287 patients aged 12-17 years were recruited and randomized 1:1:1, on top of topical therapy, to receive abrocitinib 100mg (n=95), abrocitinib 200mg (n=94), or a matched placebo (n=96) for 12 weeks.1 The co-primary endpoints of JADE TEEN, which were assessed at the end of the treatment period, included an Investigator’s Global Assessment (IGA) response of 0 (clear) to 1 (almost clear) with an improvement of ≥2 points from baseline, as well as a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) response.1

Results of JADE TEEN showed that at week 12, a substantially higher proportion of patients treated with abrocitinib 100mg (41.6%) and 200mg (46.2%) achieved an IGA response of 0/1 as compared with 24.5% with placebo.1 In addition, more patients achieved the EASI-75 endpoint with patients on abrocitinib 100mg (68.5%) and 200mg (72.0%) than the placebo group (41.5%).1

The most reported treatment-emergent adverse events (TEAEs) with abrocitinib were nausea and upper respiratory tract infection.1 The adverse events (AEs) of special interest, herpes-related AEs and conjunctivitis were infrequent.1 There were also no cases of serious infection, venous thromboembolism (VTE), cancers, major adverse cardiovascular events (MACEs), or deaths.1 Notably the rates of severe TEAEs were similar among all study arms.1 Overall, the safety profile shown in JADE TEEN was consistent with the previous studies in the adult population.2

The positive results of the JADE TEEN trial have provided a new oral treatment for adolescents burdened by moderate-to-severe AD.2 Abrocitinib provides a much-needed alternative for young patients who have yet to find relief with the current treatment options.2

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