Topical tofacitinib for atopic dermatitis: a phase IIa randomized trial

Area of Science:

• Dermatology
• Immunology
• Pharmacology

Background:

• A 15-year gap exists in topical therapies for atopic dermatitis (AD) with novel mechanisms.
• The efficacy of topical Janus kinase (JAK) inhibitors for AD remains unestablished.

Purpose of the Study:

• To investigate the efficacy and safety of topical tofacitinib for treating mild-to-moderate atopic dermatitis (AD).
• To evaluate tofacitinib's potential as a topical therapeutic agent for AD.

Main Methods:

• A 4-week, randomized, double-blind, vehicle-controlled Phase IIa study involving 69 adults with mild-to-moderate AD.
• Participants received either 2% tofacitinib ointment or a vehicle control twice daily.
• Primary endpoint was the percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 4; secondary endpoints included body surface area (BSA) involvement, clinical signs, Physician's Global Assessment (PGA), and pruritus.

Main Results:

• Topical tofacitinib demonstrated a significantly greater reduction in EASI score (-81.7%) compared to vehicle (-29.9%) at week 4 (P < 0.001).
• Significant improvements were observed for all efficacy endpoints, including pruritus, with tofacitinib versus vehicle.
• Early onset of action was noted, with improvements in EASI, PGA, and BSA by week 1, and pruritus by day 2. Safety and local tolerability were comparable between groups.

Conclusions:

• Topical tofacitinib ointment is significantly more effective than vehicle for treating atopic dermatitis (AD), demonstrating rapid and comparable safety.
• Topical delivery of Janus kinase (JAK) inhibitors represents a promising therapeutic strategy for AD management.