Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis - 11/02/19
, Robert Bissonnette, MD b, Tomoko Maeda-Chubachi, MD, PhD c, Li Ye, MS a, Johnny Peppers, PhD d, Kelly Gallagher, MS a, John E. Kraus, MD, PhD eAbstract |
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.
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
Plan
| Funding sources: Supported by GSK (protocol 203120). |
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| 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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| Reprints not available from the authors. |
Vol 80 - N° 3
P. 714-721 - mars 2019 Retour au numéro
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