Dermavant Sciences releases VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist for the topical treatment of plaque psoriasis in adults, the first of its kind.
The data from two similar multi-centre, randomized, double-blind, vehicle-controlled, Phase III clinical trials named PSOARING-1 and PSOARING-2 were used by the US FDA to approve Vtama.
The trials were carried out to determine the safety and efficacy of Vtama cream for the treatment of plaque psoriasis in adults. The studies enrolled a total of 1,025 people who were randomly assigned to Vtama cream or vehicle cream for once-daily administration for 12 weeks in a 2:1 ratio.
The clinical response of the patients after 12 weeks was the primary outcome of the investigations. The Physician's Global Assessment (PGA), a five-point scale, was used to categorize disease severity (PGA). Complete disease clearance (PGA=0) or practically clear skin (PGA=1), as well as a two-grade improvement from baseline, were considered treatment successes.
In the PSOARING-1 research, 36% of patients who received Vtama cream had normal or almost clear skin, compared to only 6% of those who received vehicle cream. In the PSOARING-2 research, 40% of patients treated with Vtama cream had clear or almost normal skin, compared to only 6% of those treated with vehicle cream.
After stopping therapy with Vtama cream, the median duration of clear or almost clear skin was about four months. The usage of Vtama cream weekly resulted in a response that lasted up to 52 weeks.
Patients who completed the PSOARING 1 or 2 trials were offered the opportunity to participate in PSOARING 3, a Phase III long-term extension (LTE) investigation. The Phase III LTE study was chosen by 92% of eligible patients. A 40-week open-label treatment with Vtama cream was used in the study, followed by a four-week follow-up.
At some point during the study period, more than 40% of the patients in the LTE study achieved complete illness clearance (PGA=0). Following the completion of the LTE research, the patients were treated with Vtama cream for up to 52 weeks. Vtama cream was deemed more beneficial by 81.7% of patients than earlier topical therapies.
The PSOARING 1 and 2 investigations, as well as the LTE studies, found Vtama cream to be safe and tolerable.
Folliculitis (red raised bumps around hair pores), pain or swelling in the nose and mouth, contact dermatitis, headache, itching, and influenza were the most common side effects observed in individuals treated with Vtama cream.
Plaque psoriasis is a chronic inflammatory skin condition marked by rashes that develop on the skin as red or flaky white scales. Genetic and environmental factors are primarily responsible for the condition.
Tapinarof is an aryl hydrocarbon receptor (AhR) modifying medicinal drug (TAMA). The exact mechanism through which the cream works to treat psoriasis has yet to be discovered.