Pfizer has reported positive results from the Phase III JADE MONO-1 clinical trial of its investigational Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients with moderate to severe atopic dermatitis.
The 12-week study compared a 200mg and 100mg dose of abrocitinib with placebo in 387 patients aged 12 years and over.
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JADE MONO-1 forms part of Pfizer’s JADE global development programme.
The trial’s primary endpoint was the proportion of patients experiencing a score of clear (zero) or almost clear (one) skin on the Investigator Global Assessment (IGA), and a two-point or higher improvement relative to baseline.
The co-primary endpoint was the proportion of participants achieving at least a 75% or greater change in Eczema Area and Severity Index (EASI) score from baseline.
Key secondary endpoints were a four-point or greater decrease in itch severity on the pruritus numerical rating scale (NRS) and the magnitude of reduction in Pfizer’s pruritus and symptoms assessment for atopic dermatitis (PSAAD) scale.
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By GlobalDataAbrocitinib met all co-primary and secondary endpoints and displayed significant improvements in IGA, EASI-75, NRS ≥4-Point and EASI-90 response rates compared to placebo.
Improvements were observed to be significantly greater with both doses.
The most frequent abrocitinib-related treatment-emergent adverse events were short-lasting nausea, headache and nasopharyngitis, while subjects treated with placebo experienced dermatitis more frequently.
Pfizer Global Product Development Inflammation & Immunology chief development officer Michael Corbo said: “There is a critical need for additional treatment options for patients living with moderate to severe atopic dermatitis.
“We are pleased by these findings, which together with the recently reported positive top-line results from our second Phase III trial, encourage us that, if approved, abrocitinib may provide the first oral, once-daily treatment option for these patients.”
The company expects to report new data from the JADE programme early next year.
