Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase3 Trials in Adults with Mild to Severe Plaque Psoriasis.

Abstract

Patients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week trials: PSOARING1 (NCT03956355) and PSOARING2 (NCT03983980). Here, we present patient-reported pruritus outcomes from these trials. Outcomes included a Peak Pruritus Numerical Rating Scale (PP-NRS) score of 0 or 1 (itch-free state); Dermatology Life Quality Index (DLQI) itch item scores; and Psoriasis Symptom Diary (PSD) itch item scores. Analyses included 683 tapinarof- and 342 vehicle-treated patients. At baseline, mean pruritus scores were similar across trials with only 7-11% of patients reporting an itch-free state. At week12, the proportion of tapinarof-treated patients achieving an itch-free state was 50% in both trials compared with 32% (P = 0.0007) and 27% (P < 0.0001) in the vehicle groups. Improvements were apparent at the earliest assessments with continued improvement over the course of the trials. There were rapid and statistically significant improvements in the proportion of patients with a ≥ 4-point improvement in PP-NRS for tapinarof-treated patients versus vehicle from week2 with 68% vs 46% (P = 0.0004) and 60% vs 31% (P = 0.0001) at week12 achieving a response in each trial. Significantly greater reductions in itch with tapinarof versus vehicle were also demonstrated at week12 for DLQI itch item1 (P = 0.0026 and P < 0.0001), PSD item1 (both P < 0.0001), and PSD item2 (both P < 0.0001). Tapinarof was highly efficacious in reducing pruritus across multiple patient-reported outcome measures, with rapid, statistically significant, and clinically meaningful improvements. The high proportion of patients achieving the treatment target of an itch-free state at week12 (50%) is a noteworthy clinical outcome for a non-steroidal topical cream in the treatment of mild to severe plaque psoriasis. Clinical trial registration information: NCT03956355, NCT03983980.