Pfizer has presented positive phase 3 data at the 28th Congress of the European Academy of Dermatology and Venereology for abrocitinib in moderate to severe atopic dermatitis, in which abrocitinib met all co-primary and secondary endpoints in JADE MONO-1 study.
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today complete results from a Phase 3, 12-week, pivotal study (JADE MONO-1) in patients aged 12 and older with moderate to severe atopic dermatitis (AD). Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor, met all the co-primary and key secondary endpoints, which were related to skin clearance and itch relief compared to placebo. Safety data showed that both evaluated doses of abrocitinib (200mg and 100mg) were well tolerated and were consistent with a companion study (JADE MONO-2) from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. The results were shared as a Late-Breaking presentation at the 28th Congress of the European Academy of Dermatology and Venereology (EADV) taking place October 9-13, 2019 in Madrid, Spain.
The co-primary study endpoints in JADE MONO-1 were the proportion of patients who achieved an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin and two-point or greater improvement relative to baseline; and the proportion of patients who achieved at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score. The key secondary endpoints were the proportion of patients achieving a four-point or larger reduction in itch severity measured with the pruritus numerical rating scale (NRS), and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD), a patient-reported measurement scale developed by Pfizer. Other secondary endpoints included the proportion of patients who achieved a 90% or greater change in EASI score, and the percentage change from baseline in their SCORing Atopic Dermatitis (SCORAD) response at all scheduled time points.
“There is a critical need for additional treatment options for patients living with moderate to severe atopic dermatitis,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We are pleased by these findings, which together with the recently reported positive top-line results from our second Phase 3 trial, encourage us that, if approved, abrocitinib may provide the first oral, once-daily treatment option for these patients.”
JADE MONO-1 Study Efficacy Results1
Both doses of abrocitinib significantly improved the IGA and EASI-75 dose response outcomes compared to placebo. By week 12, the following co-primary efficacy and secondary endpoint results were seen:
|
|
Abrocitinib 200mg (N=154) |
Abrocitinib 100mg (N=156) |
Placebo (N=77) |
|
IGA Response Rate |
43.8% |
23.7% |
7.9% |
|
EASI-75 Response Rate |
62.7% |
39.7% |
11.8% |
|
NRS ≥4-Point Improvement Response Rate |
57.2% |
37.7% |
15.3% |
|
EASI-90 Response Rate |
38.6% |
18.6% |
5.3% |
The percentage changes in SCORAD were significantly greater at all time points in the 200mg and 100mg treatment arms compared to placebo.
JADE MONO-1 Safety Results1
The most frequently reported treatment-emergent adverse events in abrocitinib-treated patients (200mg, 100mg) were short-lasting nausea (20.1%, 9.0%), headache (9.7%, 7.7%), and nasopharyngitis (11.7%, 14.7%), while for placebo, it was dermatitis (16.9%). Observed serious adverse events (SAEs) for abrocitinib 200mg were inflammatory bowel disease, peritonsillitis, dehydration, and asthma (2 cases). SAEs seen for the 100mg dose included retinal detachment, acute pancreatitis, appendicitis, dizziness, and seizures. In the placebo arm, SAEs were condition aggravated, appendicitis, meniscal degeneration, and atopic dermatitis. Other safety findings included:
|
|
Abrocitinib 200mg (N=154) |
Abrocitinib 100mg (N=156) |
Placebo (N=77) |
|
Rate of Serious Adverse Events |
3.2% |
3.2% |
1.9% |
|
Rate of Discontinuation due to an Adverse Event |
5.8% |
5.8% |
9.1% |