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

Publication date: Available online 26 October 2018

Source: Journal of the American Academy of Dermatology

Author(s): Kevin Robbins, Robert Bissonnette, Tomoko Maeda-Chubachi, Li Ye, Johnny Peppers, Kelly Gallagher, John E. Kraus

Abstract

Background

There is a significant need for novel, safe and efficacious topical treatments for psoriasis.

Objective

We assessed the safety and efficacy of tapinarof in a new cream formulation in 2 concentrations and 2 application frequencies in adults with psoriasis.

Methods

Double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in adults, with psoriasis with body surface (BSA) involvement ≥1% and ≤15% and PGA ≥2 at Baseline. Primary endpoint included PGA = 0 or 1 at Week 12, and a 2-grade improvement from Baseline. Additional analyses included PASI75 and mean percent change in PASI and BSA.

Results

Treatment success defined by PGA 0 or 1 and a 2-Grade Improvement at Week 12 were statistically significantly higher (at a 0.05 significance level) in the tapinarof groups than the vehicle groups: (65% [1%BID]; 56% [1%QD]; 46% [0.5%BID]; 36% [0.5%QD]; 11% [vehicle BID], and 5% [vehicle QD]) and was maintained for 4 weeks post-treatment. Treatment-emergent adverse events (TEAEs) were higher with tapinarof (85/152 patients [56%] compared to vehicle 19/75 patients [25%]) and mild-to-moderate in intensity. Severe TEAEs were reported in all tapinarof groups except 0.5% QD.

Limitations

Large confirmation trials are needed.

Conclusions

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