Treatment of atopic dermatitis Pfizer JAK1 inhibitor Phase 2 single drug Phase III study reached double endpoint

Pfizer recently released the full results of the second key single-drug Phase III study (JADEMONO-2) for the oral JAK1 inhibitor abrocitinib treatment for atopic dermatitis (AD)The data were conducted in patients aged to severe AD aged 12 and older, and the data were consistent with the first single-drug Phase III study (JADE MONO-1): the study reached all common primary and critical secondary endpointsCompared to placebo, both doses of abrocitinib showed statistically significant advantages in improving skin damage removal, eczema area and severity, and itchingJADE MONO-2 is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of arocitinib monotherapy for 12 weeksIn the study, a total of 391 patients with moderate to severe AD were randomly assigned to a daily abrocitinib 200 mg, 100 mg, placebo treatmentThe end point of efficacy was skin damage removal, disease area and severity, and improvement of itchingThe common primary endpoint of thestudy was the percentage of patients who achieved the following goal: total assessment of the researchers in the 12th week of treatment (IGA) for complete removal of skin damage (IGA score of 0) or almost complete elimination (IGA score of 1) and relative baseline improvement of 2 points, treatment of the 12th week eczema area and severity index (EASI) score by 75% relative to the baselineThe critical secondary endpoint was in the 2nd, 4th, and 12th weeks of treatment, where the severity of itching as measured by the peak itching numerical scale (PP-NRS) decreased by 4 points compared to the baselineThe proportion of patients with eASI scores in the 12th week of treatment with a lower baseline score of .90% (EASI-90) was listed as a secondary endpoint in the studyRESULTS of JADE MONO-2 study: byto 12 weeks, the proportion of patients treated with abrocitinib was higher than in patients treated with aplacebo, IAComitinib, EASI-75, PP-NRS, EASI-90, and the common primary effect The end and secondary endpoint results are as follows:from week 2 to week 12, the proportion of patients who responded igA, EASI-75, PP-NRS, EASI-90 at every point in time was higher than placebo, and the response occurred as early as Week 2Safety results of theJADE MONO-2 study: Adverse events (TEAE) that were most commonly reported in thestudy were nausea, nasopharyngitis and atopic dermatitis, as follows: 2 patients in the 100mg treatment group were reported (herpes-like pharythalysis and staphylococcus infection) observed in thestudy 1 patient with cardiovascular risk factors died three weeks after taking the last dose of 100mg abrocitinib, which investigators believe was not related to the drug studies, leading to the most common adverse events of discontinuation, the 200mg treatment group was headache, the 100mg treatment group and the placebo group were the subjectitoderitis asexual dermatitis is a chronic skin disease characterized by skin inflammation and skin barrier defects, characterized by erythema (redness), itching, hard knots/papules, oozing/clumping, is one of the most common, chronic, recurrent skin diseases, affecting 10% of adults and 20% of children worldwide JADE MONO-2 is the second trial in the JAK1 Atopic Dermatitis Treatment and Safety Global Development Project (JADE) Pfizer recently announced the results of a third test of jade COMPARE positive Additional data from other studies of the JADE project will be available later this year in the United States, the FDA granted breakthrough drug eligibility for patients with moderate to severe AD treatment in February 2018 Pfizer plans to submit a new application for a new drug for arocitinib treatment for AD to the FDA later this year Reference source: Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology