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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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
StatePublished - Jan 1 2019

Fingerprint

Atopic Dermatitis
Therapeutics
Research Personnel
Body Surface Area
Eczema
Double-Blind Method
Safety

Keywords

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

ASJC Scopus subject areas

  • Dermatology

Cite this

Peppers, Johnny ; Paller, Amy ; Maeda-Chubachi, Tomoko ; Wu, Sterling ; Robbins, Kevin ; Gallagher, Kelly ; Kraus, John E. / A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. In: Journal of the American Academy of Dermatology. 2019 ; Vol. 80, No. 1. pp. 89-98.e3.
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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.",
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A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. / Peppers, Johnny; Paller, Amy; Maeda-Chubachi, Tomoko; Wu, Sterling; Robbins, Kevin; Gallagher, Kelly; Kraus, John E.

In: Journal of the American Academy of Dermatology, Vol. 80, No. 1, 01.01.2019, p. 89-98.e3.

Research output: Contribution to journalArticle

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T1 - A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis

AU - Peppers, Johnny

AU - Paller, Amy

AU - Maeda-Chubachi, Tomoko

AU - Wu, Sterling

AU - Robbins, Kevin

AU - Gallagher, Kelly

AU - Kraus, John E.

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N2 - 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.

AB - 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.

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