There is a significant need for novel, safe, and efficacious topical treatments for psoriasis.
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.
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.
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.
Large confirmation trials are needed.
Tapinarof cream is efficacious and well tolerated in adult patients with psoriasis.Le texte complet de cet article est disponible en PDF.
Key words : GSK2894512, psoriasis, TAMA, tapinarof, therapeutic AhR (aryl hydrocarbon receptor) modulating agent
Abbreviations used : AE, AhR, BSA, CI, PASI, PASI75, PGA, PASI, IL, TEAE
| Funding sources: Supported by GSK (protocol 203120).
| Conflicts of interest: Dr Bissonnette served as a consultant, investigator, advisory board member, or speaker or received honorarium and/or grants from Abbvie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galderma, Immune Tolerance, Incyte, Janssen, Kineta, Leo Pharma, Merck, Novartis, Pfizer, Xenoport, and GSK. Dr Bissonnette is a shareholder of Innovaderm Research. Drs Maeda-Chubachi, Peppers, and Kraus were employees and stockholders of GSK when the study was conducted. Mr Robbins, Ms Ye, and Ms Gallagher are employees and shareholders of GSK.
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