The FDA has approved Vtama cream for the treatment of plaque psoriasis in patients with mild, moderate or severe disease, Dermavant Sciences announced.
Vtama (tapinarof) 1%, an aryl hydrocarbon receptor agonist, is the first topical drug approved for the treatment of psoriasis in more than 25 years and the only nonsteroidal drug approved for this indication.
“Vtama represents a sort of watershed moment in dermatology. We’ve seen great innovation on the systemic side of the equation, but it’s really been lacking in regard to topicals,” Philip Brown, MD, JD, chief medical officer at Dermavant Sciences, told Healio. “Vtama represents a new benchmark as it comes into the environment that will enable patients to treat their condition anywhere on their body for any length of time.”
The approval was based on data from the PSOARING 1 and 2 phase 3 trials, as well as the PSOARING 3 long-term extension (LTE) study.
Philip Brown
A statistically significant improvement in PGA score of clear or almost clear, with at least a 2-grade improvement at week 12 was achieved in 36% of patients using Vtama in the PSOARING 1 trial and 40% of those in the PSOARING 2 trial, compared to 6% of those in each respective vehicle arm.
In the LTE study, 40% of patients who achieved a PGA of 0/1 during the initial trials showed a remittive effect while off therapy for a median of 4 months.
“We believe this is a highly differentiating characteristic for Vtama and a very novel observation for a topical product,” Brown said. “We believe this is going to have a significant place within the dermatology armamentarium for the management of psoriasis.”
PERSPECTIVE
Tapinarof represents the first new topical chemical entity for the treatment of psoriasis in 25 years. Tapinarof is a novel, first-in-class, nonsteroidal, small-molecule topical aryl hydrocarbon receptor agonist which works intracellularly to decrease the expression of Th17 cytokines, including interleukin (IL)-17A and IL-17F, reducing inflammation. It also reduces oxidative stress and normalizes the skin barrier.
Tapinarof is a 1% cream formulation that was studied once daily for 12 weeks in phase 3 clinical trials in mild, moderate and severe patients with body surface areas of 3% to 20%. Up to 40% of patients achieved clear or almost clear IGA response at week 12 with a 2-grade improvement. In the long term studies, patients who entered the study with clear skin had an average remittive response of 4 months.
Tolerability of the drug was good even in sensitive areas. The most common side effects of folliculitis and contact dermatitis were generally mild to moderate.
Tapinarof offers us a drug that is effective, well tolerated and able to be used on multiple body sites including the face and sensitive areas. It provides the possibility of a durable remittive effect that may allow patient to have a drug holiday for several months. I see this as an important new tool to help our psoriasis patients achieve success.
Linda Stein Gold, MD
Director of Clinical Research
Henry Ford Health
Vice President
American Academy of Dermatology
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