Tapinarof Improves Plaque Psoriasis in Phase 3 Trials

PSOARING 1 and PSOARING 2 support the efficacy and safety of tapinarof for the treatment of mild to severe plaque psoriasis.

Tapinarof performed well in two Phase 3 plaque psoriasis trials, according to research published in the New England Journal of Medicine.

“This study reports that topical tapinarof cream, a new nonsteroidal cream for plaque psoriasis, is highly effective,” says study author Mark Lebwohl, MD, FAAD, Dean for Clinical Therapeutics and Waldman Professor and Chairman of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York, in a news release. “Efficacy is durable in those who continue on the medication; and for those who clear completely, psoriasis remains in remission for approximately four months after discontinuation of the treatment.”

And the treatment was safe, even on sensitive skin sites where there is a need for nonsteroidal therapy, he says. The most common side effect was mild to moderate folliculitis, and few patients discontinued for that.

PSOARING 1 and PSOARING 2 were identical double-blind, placebo-controlled pivotal trials that enrolled 1,025 patients aged 18-75 who had a Physician’s Global Assessment (PGA) baseline score of 2 (mild), 3 (moderate) or 4 (severe) and plaque psoriasis covering from 3 percent to 20 percent of their body surface area. Following a screening period, eligible patients were randomly assigned in a 2:1 ratio to tapinarof cream 1% or vehicle cream once daily. Participants were stratified at entry by baseline PGA score. Trial visits occurred at screening, baseline, and weeks 2, 4, 8 and 12 during the treatment period.

In August 2020, PSOARING 1 and PSOARING 2 met its primary efficacy endpoints, with tapinarof cream demonstrating a highly statistically significant improvement in proportion of patients achieving a PGA response – i.e., a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline – compared with vehicle at week 12.

 The studies also met all secondary endpoints, including proportion of patients who achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) score (PASI75) with high statistical significance, the percentage of patients with a PGA score of 0 or 1, the mean change in the percent of total body-surface are affected, and percentage of patients who had a reduction of at least 90% in the PASI (PASI90), all from baseline at week 12.