Mark G. Lebwohl, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted two identical phase 3 randomized trials of tapinarof in adults with mild-to-severe plaque psoriasis. Adults with a baseline Physician’s Global Assessment (PGA) score of 2 (mild) to 4 (severe) and 3 to 20 percent of total body-surface area affected were randomly assigned in a 2:1 ratio to 12 weeks of tapinarof 1 percent cream or vehicle cream once daily. A total of 510 and 515 patients were enrolled in trials 1 and 2, respectively.
The researchers found that a PGA response occurred in 35.4 and 6.0 percent of patients in the tapinarof and placebo groups, respectively, in trial 1 and in 40.2 and 6.3 percent of patients, respectively, in trial 2. For secondary end points and patient-reported outcomes, the results were mainly in the same direction. Folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus were adverse events associated with tapinarof cream.
“In these 12-week trials, the topical aryl hydrocarbon receptor-modulating agent tapinarof was superior to vehicle in reducing the manifestations of psoriasis but was associated with local adverse events and headache,” the authors write.