One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial

Bruce Strober, Linda Stein Gold, Robert Bissonnette, April W. Armstrong, Leon Kircik, Stephen K. Tyring, Stephen C. Piscitelli, Philip M. Brown, David S. Rubenstein, Anna M. Tallman, Mark G. Lebwohl

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


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.

Original languageEnglish
JournalJournal of the American Academy of Dermatology
StatePublished - Oct 2022


  • PSOARING 3 trial
  • plaque psoriasis
  • remittive effect
  • tapinarof
  • therapeutic aryl hydrocarbon receptor (AhR)-modulating agent


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