Pfizer has reported that Phase III JADE DARE clinical trial of its drug, abrocitinib, met the co-primary and key secondary efficacy endpoints in adults with moderate to severe atopic dermatitis (AD).
Comprising an oral small molecule, abrocitinib can specifically hinder Janus kinase (JAK) 1 to regulate various cytokines associated with AD pathophysiology.
The 26-week, randomised, double-blind, double-dummy, active-controlled, multi-centre Phase III trial assessed the efficacy of 200mg abrocitinib against 300mg dupilumab in adult AD patients who were receiving background topical treatment.
Subjects in the head-to-head trial were given either a once-daily oral 200mg abrocitinib tablet or subcutaneous dose of dupilumab every other week after an induction dose of 600mg.
The proportion of subjects attaining a minimum of a four-point improvement in the severity of the Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline at week two was one co-primary efficacy goal of the trial.
Eczema Area and Severity Index (EASI)-90 at week four was the other co-primary efficacy endpoint while the key secondary goal was the proportion of subjects attaining EASI-90 at week 16.
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According to the data from the trial, abrocitinib was statistically superior versus dupilumab in each analysed efficacy measure.
Furthermore, the safety profile of abrocitinib was in line with earlier trials in the JADE programme.
An increased percentage of subjects in the abrocitinib arm had adverse events versus the dupilumab arm.
Two deaths were reported among participants receiving abrocitinib but were found by trial investigators to be not linked to the drug.
No malignancies or venous thromboembolism events were noted through adjudication.
Pfizer Global Product Development Inflammation and Immunology chief development officer Michael Corbo said: “The results from our first formal head-to-head trial for abrocitinib illustrate its potential for meaningful symptom relief for patients and further build upon the substantial body of data from the JADE development programme.
“We’re pleased that the study findings show the potential impact abrocitinib could have to help people living with moderate to severe atopic dermatitis in reducing their itch significantly and in achieving near-complete skin clearance.”
The company anticipates submitting these results in the future to the US Food and Drug Administration (FDA) and various other regulators reviewing submissions for abrocitinib.
In October 2019, Pfizer announced promising results from its Phase III JADE MONO-1 study of abrocitinib in AD.