A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis

Johnny Peppers, Amy Paller, Tomoko Maeda-Chubachi, Sterling Wu, Kevin Robbins*, Kelly Gallagher, John E. Kraus

*Corresponding author for this work

Research output: Contribution to journalArticle

15 Scopus citations

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 and 2 application frequencies) in patients with AD. Methods: A double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients age 12 to 65 years, with body surface area involvement of at least 5% to 35% and an Investigator's Global Assessment score of 3 or higher (moderate to severe) at baseline. Primary end points included an Investigator's Global Assessment score of clear or almost clear (0 or 1) and a minimum 2-grade improvement (treatment success) at week 12. Secondary analyses included a 75% or greater improvement in Eczema Area and Severity Index score, reduction of numeric rating scale (NRS) score for itch from baseline, and other prespecified end points. Results: The rates of treatment success with tapinarof cream at week 12 were 53% (a concentration of 1% twice daily), 46% (a concentration of 1% once daily), 37% (a concentration of 0.5% twice daily), 34% (0.5% once daily), 24% (vehicle twice daily), and 28% (vehicle once daily). The rate with a concentration of 1% twice daily (53%) was statistically significantly higher than the rate with vehicle twice daily (24%). Treatment success was maintained for 4 weeks after the end of tapinarof treatment. The rate of treatment-emergent adverse events was higher with tapinarof (93 of 165 [56%]) than with vehicle (34 of 82 [41%]), and the events were 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.

Original languageEnglish (US)
Pages (from-to)89-98.e3
JournalJournal of the American Academy of Dermatology
Volume80
Issue number1
DOIs
Publication statusPublished - Jan 1 2019

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Keywords

  • GSK2894512
  • atopic dermatitis
  • tapinarof
  • therapeutic aryl hydrocarbon receptor modulating agent

ASJC Scopus subject areas

  • Dermatology

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