Pfizer announced positive top-line results from the Phase 3 JADE TEEN study of abrocitinib in patients 12 to <18 years of age with moderate to severe atopic dermatitis (AD) who were also on background topical therapy. Both doses of abrocitinib met the co-primary endpoints and were generally well tolerated.
JADE TEEN was a randomized, double-blind, placebo-controlled, parallel group study. A total of 285 subjects 12 to <18 years of age with moderate to severe atopic dermatitis were randomized to receive once daily abrocitinib 200mg, abrocitinib 100mg, or placebo for 12 weeks while also on background topical therapy. The co-primary endpoints in the study were the proportion of patients who achieved an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) and a two-point or greater reduction from baseline at Week 12; and the proportion of patients who achieved at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score at Week 12. Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically significantly higher with both doses of abrocitinib than with placebo.
Full results from JADE TEEN will be submitted for presentation at a future scientific meeting and publication in a medical journal.
JADE TEEN is the fourth trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. Additional data from other studies in the JADE program will be available later this year.
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
Abrocitinib received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate to severe AD in February 2018.
About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterized by erythema (redness), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting. Globally, AD affects up to 10% of adults and up to 20% of children.