Pfizer announced that the complete results of the second critical phase 3 clinical trial of its JAK1 inhibitor abrocitinib for atopic dermatitis developed by the company were published on JAMA Dermatology. Abrocitinib is an investigational oral JAK1 inhibitor (once a day) used in patients with moderate to severe atopic dermatitis (AD) 12 years of age and older. Consistent with the first phase 3 monotherapy study, both doses of abrocitinib met all common primary endpoints and key secondary endpoints and were well tolerated.
Atopic dermatitis is a chronic, recurrent skin disease. The main symptoms are severe itching, chapped skin, and inflammation in any part of the body. Patients with moderate to severe atopic dermatitis may cause skin damage and insomnia due to severe itching. Like other chronic inflammatory diseases, atopic dermatitis is also a disease mediated by the immune system, and the complex interaction between immune cells and inflammatory cytokines plays an important role in the occurrence of the disease. As one of the most common chronic dermatitis, it affects up to 20% of pediatric patients and 10% of adult patients worldwide. And about half of these children suffer from recurring symptoms. Therefore, they need a new drug to control their condition.
Pfizer's abrocitinib is an oral small molecule-specific JAK1 inhibitor. JAK1 inhibitors control the condition by regulating a variety of cytokines related to atopic dermatitis pathology, including interleukins IL-4, IL-13, IL-31 and interferon gamma. Previously, abrocitinib has been awarded the breakthrough therapy designation granted by the US FDA.
JADE MONO-2 is a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of abrocitinib monotherapy for 12 weeks. 391 patients with moderate to severe atopic dermatitis participated in this clinical trial.
The test results show that using a variety of different symptoms detection methods, both doses of abrocitinib significantly improved the symptoms of dermatitis compared with placebo.
Dr. Michael Corbo, Chief Development Officer, Inflammation and Immunology, Pfizer Global Product Development, said: "The results of Abrocitinib's second key clinical trial further demonstrate its potential symptomatic relief for patients with moderate to severe atopic dermatitis, including itching. One of the most disturbing symptoms of AD. If abrocitinib is approved, we hope it will bring meaningful improvements to patients facing the daily challenges of this disease."