Results from the Phase III JADE TEEN study of abrocitinib in teen patients, ages 12 to 18, who have moderate to severe atopic dermatitis and were on background topical therapy, showed improvements in skin clearance, disease extent and a reduction in severity.
Pfizer’s oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, continues to post strong clinical trial results as a treatment for atopic dermatitis. On Wednesday, the company announced positive topline data from another Phase III study that continues the winning streak.
Results from the Phase III JADE TEEN study of abrocitinib in teen patients, ages 12 to 18, who have moderate to severe atopic dermatitis and were on background topical therapy, showed improvements in skin clearance, disease extent and a reduction in severity.
The JADE TEEN study includes 285 patients in the age range with moderate to severe atopic dermatitis. They were randomized to receive once-daily abrocitinib 200mg, abrocitinib 100mg, or placebo for 12 weeks while also on background topical therapy. 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, Pfizer said in its announcement. Pfizer noted that the percentage of patients who had a clinically significant reduction in itch by Weeks 2, 4, and 12 of treatment was statistically significantly higher at each time point for the 200mg abrocitinib dose, and at Week 2 for the 100mg abrocitinib dose, compared to placebo. The 100mg dose did not achieve a significant difference at Week 4, despite having achieved it at Week 2, Pfizer added.
Atopic dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Atopic dermatitis are characterized by redness, itching, induration and oozing. It is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.
With that significant number of adolescents affected by atopic dermatitis, Michael Corbo, Pfizer’s chief development officer of inflammation and immunology, said there remains a significant unmet need for new treatment options that may improve their care. In multiple late-stage studies, abrocitinib has made a significant impact in atopic dermatitis, in children and adult patient populations. JADE TEEN marks the fourth trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program.
“For children and adolescents, these findings build on the positive results of our companion Phase III monotherapy trials that included patients twelve years and older,” Corbo said in a brief announcement.
Full results from JADE TEEN will be submitted for presentation at a future scientific meeting and publication in a medical journal, Pfizer said.
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 AD, including interleukin (IL)-4, IL-13, IL-31, and interferon gamma. JAK pathways are linked to inflammatory processes and are implicated in signaling for over 50 cytokines and growth factors. Abrocitinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with moderate to severe atopic dermatitis in February 2018.
