Abrocitinib flexibly dosed for moderate-to-severe atopic dermatitis

Expert Name
Dr Andrew Blauvelt
Expert Affiliation
Oregon Medical Research Center, USA
AAD 2021

Patients with atopic dermatitis (AD) suffer from chronic inflammation of the skin. It is a common and unpredictable skin disease, making it important to find an effective and safe treatment. Abrocitinib is a promising molecule for the potential treatment of AD. If approved, it could prevent inconvenient flares in patients.

AD is associated with uncertainty in daily life. The unpredictability of flares makes disease management challenging. The latest results from a phase 3 clinical trial were promising for the prevention of flares in AD patients. Dr Andrew Blauvelt (Oregon Medical Research Center, USA) presented the JADE REGIMEN study (NCT03627767) investigating abrocitinib, a small molecule that selectively inhibits JAK-1 [1]. This mechanism of action is thought to moderate cytokine production associated with the pathophysiology of AD, for JAK-1 reduces IL-4 and IL-13 signalling. The study evaluated the efficacy and safety of abrocitinib across different dosing regimens in patients aged ≥12 years with moderate-to-severe AD.

In this phase 3, double-blind, placebo-controlled trial, AD patients were randomly assigned to receive orally, once-daily 100 mg or 200 mg of abrocinitib or placebo. A total of 1,233 patients were enrolled globally for a study period of 52 weeks. After an induction period of 12 weeks, patients were continued on a higher dose of 200 mg abrocitinib, or switched to a lower dose of 100 mg based on their clinical response. Both doses of abrocitinib demonstrated a significant reduction of patients experiencing a loss of response requiring rescue treatment or flaring compared with patients on placebo. Of patients staying on a 200 mg dose, 81.1% did not have any reoccurrence of the disease. Of patients treated with an intermediate dose of 100 mg, 57.4% did not have flares. Overall, these results indicate a higher probability of not experiencing a flare for patients on either dose of abrocitinib.

  1. Blauvelt A. Abrocitinbib induction, randomized withdrawal and response recapture with rescue therapy in patients with moderate-to-severe atopic dermatitis: results from the JADE REGIMEN Phase 3 trial. Session S033: Late breaking abstracts. AAD VMX, April 23-25.