Pfizer reveals positive data from Phase 3 trial of ABROCITINIB
Atopic Dermatitis (AD) is a chronic skin disease characterized by skin barrier defects and inflammation. It results in itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting and affects up to 10% of adults and up to 20% of children in the world. Many researchers and pharmaceutical firms are carrying out clinical trials to develop drugs to treat this disease.
Pfizer Inc. is one such organization which has reportedly announced results of its Phase 3, 12-week, pivotal study in patients who are suffering from atopic dermatitis. Abrocitinib, the firm’s investigational JAK1 inhibitor, has shown positive results and has met all key secondary as well as co-primary endpoints in patients aged 12 years and above.
According to the trial’s safety data, both assessed doses of abrocitinib (100mg and 200mg) were well tolerated and are consistent with companion study (JADE MONO-2) from the JADE (JAK1 Atopic Dermatitis Efficacy and Safety) global development program.
Moreover, the number of subjects who achieved each co-primary and secondary efficacy endpoint was statically higher with abrocitinib as compared to placebo by the end of week 12.
Reports cite that the co-primary endpoints of the trial were an IGA (Investigator Global Assessment) score of clear (0) or almost clear (1) skin and two-point or more improvement compared to baseline, and at least a 75% or greater change in their EASI score from baseline.
Furthermore, key secondary endpoints were a four-point or more decrease in itch severity assessed using the pruritus NRS (Numerical Rating Scale), and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD).
Apparently, a considerable number of patients showed a response during the first two to four weeks in the dosing period. Both doses were well-tolerated with patients. Moreover, discontinuation rates were noted to be low as compared to placebo.
Michael Corbo, Chief Development Officer, Inflammation & Immunology of Pfizer Global Product Development, stated that there is a vital need for additional treatment options for patients who are suffering from moderate to severe atopic dermatitis. Corbo added that, if the drug is approved, abrocitinib would be the first oral, once daily treatment option for patients.
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Mateen Dalal
A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few other portals. Channelizing his e...