TY - JOUR
T1 - One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis
T2 - Results from the PSOARING 3 trial
AU - Strober, Bruce
AU - Stein Gold, Linda
AU - Bissonnette, Robert
AU - Armstrong, April W.
AU - Kircik, Leon
AU - Tyring, Stephen K.
AU - Piscitelli, Stephen C.
AU - Brown, Philip M.
AU - Rubenstein, David S.
AU - Tallman, Anna M.
AU - Lebwohl, Mark G.
N1 - Publisher Copyright:
© 2022 American Academy of Dermatology, Inc.
PY - 2022/10
Y1 - 2022/10
N2 - 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, ∼4-month off therapy remittive effect, durability on therapy, and consistent safety.
AB - 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, ∼4-month off therapy remittive effect, durability on therapy, and consistent safety.
KW - PSOARING 3 trial
KW - plaque psoriasis
KW - remittive effect
KW - tapinarof
KW - therapeutic aryl hydrocarbon receptor (AhR)-modulating agent
UR - http://www.scopus.com/inward/record.url?scp=85135514563&partnerID=8YFLogxK
U2 - 10.1016/j.jaad.2022.06.1171
DO - 10.1016/j.jaad.2022.06.1171
M3 - Article
C2 - 35772599
AN - SCOPUS:85135514563
SN - 0190-9622
VL - 87
SP - 800
EP - 806
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 4
ER -