One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial.
J Am Acad Dermatol
; 87(4): 800-806, 2022 10.
Article
en En
| MEDLINE
| ID: mdl-35772599
ABSTRACT
BACKGROUND:
Tapinarof cream 1% once daily, an aryl hydrocarbon receptor-modulating agent, was significantly more efficacious than vehicle and well tolerated in two 12-week phase 3 trials in adults with mild to severe plaque psoriasis.OBJECTIVE:
To assess long-term safety, efficacy, remittive effect, durability of response, and tolerability of tapinarof.METHODS:
Patients completing the 12-week trials were eligible for 40-weeks' open-label treatment and 4-weeks' follow-up. Treatment was based on the Physician Global Assessment (PGA) score. Patients entering with PGA≥1 received tapinarof until PGA = 0. Patients with PGA = 0 discontinued tapinarof and were monitored for remittive effect. Patients with PGA≥2 were re-treated until PGA = 0.RESULTS:
Overall, 91.6% (n = 763) of eligible patients enrolled; 40.9% of patients achieved complete disease clearance (PGA = 0), and 58.2% entering with PGA≥2 achieved PGA = 0 or 1. Mean duration of off therapy remittive effect for patients achieving PGA = 0 was 130.1 days. No new safety signals were observed. Most frequent adverse events were folliculitis (22.7%), contact dermatitis (5.5%), and upper respiratory tract infection (4.7%).LIMITATIONS:
Open-label; no control; may not be generalizable to all forms of psoriasis; remittive effect/response rate potentially underestimated.CONCLUSIONS:
Efficacy improved beyond the 12-week trials, with a 40.9% complete disease clearance rate, â¼4-month off therapy remittive effect, durability on therapy, and consistent safety.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Psoriasis
/
Receptores de Hidrocarburo de Aril
Tipo de estudio:
Diagnostic_studies
Límite:
Adult
/
Humans
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2022
Tipo del documento:
Article