Improvement in plaque psoriasis seen in phase 3 trials of tapinarof cream
Tapinarof cream showed positive results in treating plaque psoriasis in two phase 3 clinical trials, Dermavant Sciences announced in a press release.
The identical, multicenter, randomized, vehicle-controlled, double-blind, parallel PSOARING 1 and PSOARING 2 studies evaluated the efficacy and safety of tapinarof cream 1% in 1,025 adult subjects with plaque psoriasis.
Patients were randomly assigned in a 2:1 ratio to receive once-daily tapinarof cream or vehicle cream.
At week 12, 35.4% of treated subjects in PSOARING 1 and 40.2% of treated subjects in PSOARING 2 had a Physician’s Global Assessment score of clear or almost clear, with at least a two-grade improvement, compared with 6% and 6.3% of subjects, respectively, in the control groups (both P < .0001).
In addition, a 75% or more improvement in Psoriasis Area and Severity Index was recorded in 36.1% and 47.6% of patients in the treatment groups at week 12 compared with 10.2% and 6.9% in the vehicle groups (both P < .0001).
“Based on previously published data and my firsthand experience as an investigator, these highly statistically significant phase 3 results point to tapinarof as an effective potential new treatment for psoriasis,” Mark G. Lebwohl, MD, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai and the lead investigator for the PSOARING 1 study, said in the release. “As a nonsteroidal topical cream with the level of efficacy demonstrated in the PSOARING studies, and the potential versatility to be used across mild, moderate and severe plaque psoriasis, including intertriginous and other sensitive skin areas, I believe tapinarof could become an important treatment for adult patients suffering from this skin disorder.”
Adverse events were consistent with those in the phase 2b trial and included folliculitis, nasopharyngitis and contact dermatitis. No serious adverse events related to tapinarof were reported.