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

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-termsafety, 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 achievedPGA=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,similar to 4-month off therapy remittive effect, durability on therapy, and consistent safety.