Treat-to-Target Outcomes With Tapinarof Cream 1% in Phase 3 Trials for Plaque Psoriasis

The National Psoriasis Foundation (NPF) treatment targets aim to achieve 1% or lower body surface area (BSA) affected after 3 months of treatment. European psoriasis treatment guidelines aim to achieve similar goals based on improvements in Psoriasis Area and Severity Index (PASI) scores. We performed pooled analyses of the PSOARING phase 3 program, which evaluated treat-to-target outcomes for patients treated with tapinarof cream 1% once daily (QD) for up to 52 weeks. Our analyses included 915 patients from PSOARING 1 and PSOARING 2 who had Physician Global Assessment (PGA) scores of 2 or higher before undergoing treatment with tapinarof, including those who received the vehicle in PSOARING 1 and PSOARING 2 and then tapinarof in PSOARING 3. The treatment targets we analyzed included the proportion of patients achieving an absolute BSA of 1% or lower or an absolute total PASI score of 3 or lower. In total, 40% of patients achieved the stringent NPF target of BSA of 1% or lower within 3 months, and 61% achieved a BSA of 1% or lower at any time (median, ~4 months). Furthermore, 75%, 67%, and 50% achieved PASI scores of 3, 2, and 1 or lower, respectively, at any time (median, ~2-6 months). Our results indicated that a high percentage of patients with mild to severe psoriasis can achieve and exceed ambitious treatment targets when treated with topical tapinarof monotherapy for up to 1 year.