A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis - 13/12/18
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.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, GSK2894512, tapinarof, therapeutic aryl hydrocarbon receptor modulating agent
Abbreviations used : AE, AhR, BSA, CI, EASI, EASI75, IGA, NRI, NRS, TEAE
Plan
Funding sources: Supported by GlaxoSmithKline (protocol 203121). |
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Disclosure: Dr Paller has been a consultant with honorarium and investigator for GlaxoSmithKline (GSK). Drs Maeda-Chubachi, Peppers, and Kraus were employees and stockholders of GSK when the study was conducted. Mr Robbins, Mr Wu, and Ms Gallagher are employees and shareholders of GSK. |
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Reprints not available from the authors. |
Vol 80 - N° 1
P. 89 - janvier 2019 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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