A new nonsteroidal agent, tapinarof cream 1%, is approved for adults with plaque psoriasis based on studies showing a high degree of efficacy and minimal risk of adverse events with daily use.
New Drugs: Tapinarof Cream
By Ted Rosen, MD
Tapinarof Cream 1% (Vtama, Dermavant) was recently FDA approved to treat mild, moderate, or severe plaque psoriasis in adult patients.
This is a first-in-class agent, a fully synthetic, hydroxylated stilbene compound, which works as an aryl hydrocarbon receptor agonist. It leads to down regulation of proinflammatory cytokine expression, particularly interleukin (IL)-17.
The agent also impacts barrier gene expression in human keratinocytes, a property perhaps more important in atopic dermatitis.
The approved dosage is once daily application to involved skin. Needless to say, it is not approved for oral, ophthalmic, or intravaginal use.
Approval was based upon the results of two randomized, double-blind, multicenter, vehicle-controlled clinical trials (PSOARING 1 and PSOARING 2). In these pivotal trials 1025 adults with plaque psoriasis were treated with VTAMA cream or vehicle cream once daily for up to 12 weeks. Study subjects ranged in age from 18 to 75 years, with an overall median age of 51 years. The majority of subjects were white (85%) and male (57%).
The majority of subjects had “moderate” disease (82%), while 10% had “mild” disease, and 8% had “severe” disease at baseline.
The primary efficacy endpoint in both studies was the proportion of subjects who achieved treatment success, defined as a Physician’s Global Assessment (PGA) score of “clear” (0) or “almost clear” (1) and at least a 2-grade improvement from baseline.
Treatment success was achieved by 36% to 40% in the tapinarof treated groups but only in 6% of the vehicle treated groups.
Seventy-three subjects who were randomized to tapinarof achieved complete disease clearance (PGA 0) and had the agent withdrawn. These subjects were followed for up to 40 additional weeks with a median time to first worsening (PGA ≥ 2 [“Mild”]) of 114 days.
The most common adverse events included folliculitis, nasopharyngitis, contact dermatitis (7%), headache, and itching. Folliculitis and contact dermatitis led to treatment discontinuation in just under 3% of study subjects.
Safety in pregnancy and during lactation is unknown.
This new non-steroidal agent offers a high degree of efficacy with daily use, without time limitations, and with minimal risk of adverse events. It represents a valuable addition to the topical armamentarium against psoriasis.
Suggested Reading:
Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. N Engl J Med. 2021;385(24):2219-2229. doi:10.1056/NEJMoa2103629.
Dr. Rosen is Professor of Dermatology, Baylor College of Medicine, Houston, Texas, and Editor-in-Chief of The Dermatology Digest.
