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J Am Acad Dermatol. 2019 Mar;80(3):714-721. doi: 10.1016/j.jaad.2018.10.037. Epub 2018 Oct 26.

Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis.

Author information

1
GSK, Collegeville, Pennsylvania. Electronic address: kevin.x.robbins@gsk.com.
2
Innovaderm Research Inc, Montreal, Canada.
3
Novan Inc, Morrisville, Raleigh.
4
GSK, Collegeville, Pennsylvania.
5
PRA Health Sciences, Raleigh.
6
ICON plc, Research Triangle Park, North Carolina.

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 at 2 concentrations and with 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 involvement ≥1% and ≤15% and Physician Global Assessment (PGA) score ≥2 at baseline. Primary endpoint included PGA of 0 or 1 at week 12 and a 2-grade improvement from baseline. Additional analyses included assessment of ≥75% improvement of Psoriasis Area and Severity Index and mean percent change in Psoriasis Area and Severity Index and body surface area involvement.

RESULTS:

Treatment success defined by PGA 0 or 1 and a 2-grade improvement at week 12 was statistically significantly higher (at a .05 significance level) in the tapinarof groups (65% [1% twice daily], 56% [1% once daily], 46% [0.5% twice daily], and 36% [0.5% once daily]) than in the vehicle groups (11% [twice daily] and 5% [once daily]) and was maintained for 4 weeks posttreatment. Treatment-emergent adverse events were more frequent in patients treated with tapinarof (85/152, 56%) than vehicle (19/75, 25%) and mild-to-moderate in intensity. Severe treatment-emergent adverse events were reported in all tapinarof groups except the 0.5% once daily group.

LIMITATIONS:

Large confirmation trials are needed.

CONCLUSIONS:

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

KEYWORDS:

GSK2894512; TAMA; psoriasis; tapinarof; therapeutic AhR (aryl hydrocarbon receptor) modulating agent

PMID:
30612986
DOI:
10.1016/j.jaad.2018.10.037
[Indexed for MEDLINE]

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