General Information

Vtama (tapinarof) cream 1% is an aryl hydrocarbon receptor agonist.

Vtama is specifically indicated for the topical treatment of plaque psoriasis in adults.

Vtama is supplied as a cream for topical administration. Apply a thin layer of cream to affected areas once daily. Wash hands after application, unless Vtama cream is for treatment of the hands.

Mechanism of Action

Vtama (tapinarof) is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic action in psoriasis patients are unknown.

Side Effects

Adverse effects associated with the use of Vtama cream may include, but are not limited to, the following:

• folliculitis
• nasopharyngitis
• contact dermatitis
• headache
• pruritus
• influenza

Clinical Trial Results

FDA approval of Vtama was based on two multicenter, randomized, double-blind, vehicle-controlled trials in adults with plaque psoriasis (PSOARING 1 and PSOARING 2. These trials were conducted in a total of 1,025 subjects randomized 2:1 to Vtama cream or vehicle cream applied once daily for 12 weeks to any lesion regardless of anatomic location. Baseline disease severity was graded using the 5-point Physician’s Global Assessment (PGA). The majority of subjects had “Moderate” disease (82%), while 10% had “Mild” disease, and 8% had “Severe” disease at baseline. The extent of disease involvement assessed by mean body surface area (BSA), excluding the scalp, palms, and soles, was 8%.

The primary efficacy endpoint in both studies was the proportion of subjects who achieved treatment success, defined as a PGA score of “Clear” (0) or “Almost Clear” (1) and at least a 2-grade improvement from baseline.

• PSOARING 1: PGA Treatment Success: 36% for Vtama patients versus 6% for placebo, a 29% treatment difference.
• PSOARING 2: PGA Treatment Success: 40% for Vtama patients versus 6%, for placebo, a 34% treatment difference.

Following 12 weeks of treatment, 73 subjects randomized to Vtama achieved complete disease clearance (PGA 0) and had Vtama withdrawn. These subjects were followed for up to 40 additional weeks with a median time to first worsening (PGA ≥ 2 [“Mild”]) of 114 days.