Researchers in the JADE MONO-1 study investigated whether patients aged 12 years and older with moderate to severe atopic dermatitis would achieve with abrocitinib could achieve clear or almost clear skin with abrocitinib.
Abrocitinib led to a higher skin clearance as well as itch relief compared with a placebo in patients aged 12 years and older with moderate to severe atopic dermatitis (AD), according to a phase 3, 12-week, pivotal study called JADE MONO-1.
The findings showed that evaluated doses of abrocitinib (200 mg and 100 mg) were well tolerated and consistent with a companion study, JADE MONO-2, from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program.
Atopic dermatitis is the most common type of eczema, often appearing as a red, itchy rash normally on the cheeks, arms, and legs. Researchers in the JADE MONO-1 study investigated whether patients would achieve an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin and 2-point or greater improvement relative.
The secondary endpoints for the study were how many patients achieved a 4-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.
Approximately 43.8% and 23.7% of participants who received abrocitinib 200 mg and 100 mg, respectively, demonstrated a score of clear (0) or almost clear (1), whereas only 7.9% of patients achieved the same result with the placebo. Furthermore, 57.2% of patients with abrocitinib achieved an NRS ≥4-point improvement response rate compared with 15.3% in patients who received a placebo.
The most frequently reported adverse events (AEs) in abrocitinib-treated patients (200 mg, 100 mg) were short-lasting nausea (20.1%, 9.0%, respectively), headache (9.7%, 7.7%, respectively), and nasopharyngitis (11.7%, 14.7%, respectively), whereas for placebo, it was dermatitis (16.9%). Observed serious adverse events (SAEs) for abrocitinib 200 mg were inflammatory bowel disease, peritonsillitis, dehydration, and asthma.
The rate of SAEs was the same for both doses of abrocitinib at 3.2% and a 1.9% rate, respectively, for placebo. However, the rate of discontinuation due to an AE was 9.1% for the placebo and only 5.8% for either dose of abrocitinib.
If approved, abrocitinib may provide the first oral, once-daily treatment options for patients with AD.