A Phase 2, Randomized Dose-Finding Study of Tapinarof (GSK2894512 Cream) for the Treatment of Atopic Dermatitis

Publication date: Available online 3 July 2018

Source: Journal of the American Academy of Dermatology

Author(s): Johnny Peppers, Amy S. Paller, Tomoko Maeda-Chubachi, Sterling Wu, Kevin Robbins, Kelly Gallagher, John E. Kraus

Abstract

Background

Safe and efficacious topical treatments are needed for atopic dermatitis (AD).

Objective

We assessed the safety and efficacy of tapinarof cream (2 concentrations; 2 application frequencies) in patients with AD.

Methods

Double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients aged 12-65 years, with body surface area (BSA) involvement ≥5% and ≤35% and Investigator Global Assessment (IGA) ≥3 (moderate-severe) at Baseline. Primary endpoint included IGA score of clear or almost clear (0 or 1), and minimum 2-grade improvement ("treatment success") at Week 12. Secondary analyses: ≥ 75% improvement in Eczema Area Severity Index (EASI 75), reduction of numeric rating scale (NRS) Itch from Baseline, and other prespecified endpoints.

Results

Treatment success rates at Week 12 were: 53% [1% BID]; 46% [1% QD]; 37% [0.5% BID]; 34% [0.5% QD]; 24% [vehicle BID]; 28% [vehicle QD]. The rate (53%) of 1% BID was statistically significantly higher than (24%) vehicle BID. Treatment success was maintained for 4 weeks after end of tapinarof treatment. Treatment-emergent adverse events (TEAE) were higher with tapinarof (93/165; 56%) vs. vehicle (34/82; 41%) and mild-to-moderate in intensity.

Limitations

Large confirmation trials are needed.

Conclusions

Tapinarof cream is efficacious and well tolerated in adolescent and adult patients with AD.