Dermavant Sciences Vtama Cream

The FDA has approved tapinarof 1% cream (Vtama; Dermavant Sciences) for the topical treatment of plaque psoriasis in adults.1 Psoriasis affects approximately 8 million Americans and 125 million people worldwide, with plaque psoriasis being the most common. This condition is characterized by raised, scaly patches of skin that can be disfiguring, itchy, and painful.

Although the exact cause of psoriasis is unknown, risk factors and triggers can include cold or dry weather conditions, family history, genetics, heavy alcohol consumption, smoking, and stress. Patients with psoriasis have an increased risk of developing other health problems, such as diabetes, depression, hypertension, inflammatory bowel disease, obesity, and psoriatic arthritis. The condition can also significantly affect psychological health and quality of life.2

Clinical pharmacology

Vtama cream is an agonist of aryl hydrocarbon receptors. The exact mechanism by which Vtama cream exerts its effect in patients with psoriasis is unknown. Repeated topical application of the drug does not lead to accumulation. Plasma concentration was below quantifiable assay limits in 68% of pharmacokinetic samples.1

Dosage and administration

A thin layer of Vtama cream should be applied to the affected areas once a day. Patients should wash their hands after applying the medication, unless the treatment area is the hands. Vtama cream is not intended for intravaginal, ophthalmic or oral use.1

Clinical tests

The efficacy and safety of Vtama cream for the treatment of plaque psoriasis in adults was evaluated in 2 double-blind, multicenter, randomized, vehicle-controlled trials (PSOARIN 1 [NCT03956355] and PSOARING 2 [NCT03983980]). A total of 1025 participants were randomized 2:1 to apply either Vtama cream or vehicle cream once daily for 12 weeks to any lesion, regardless of location on the body. Baseline psoriasis severity was assessed using the 5-point Physician’s Global Assessment (PGA), which classified 10% of participants as having mild disease, 82% as having moderate disease, and 8 % as having a serious illness. The extent of disease involvement, which was assessed by mean body surface area (excluding palms, scalp and soles), was 8%, with a range of 3% at 20%.

The primary measure of effectiveness in both studies was the proportion of participants who achieved treatment success, defined as a clear or almost clear PGA score and an improvement of at least 2 grades from baseline. The results of both trials showed a statistically significant improvement in patients using Vtama cream compared to those using vehicle cream. In PSOARING 1, 36% of the Vtama cream group achieved therapeutic success versus 6% of the vehicle cream group. In PSOARING 2, treatment success was achieved in 40% of the Vtama cream group and 6% of the vehicle cream group.

Vtama Cream also demonstrated statistically significant improvement in all secondary endpoints, including a 75% or greater improvement in the Area Improvement Score and Psoriasis Severity Index from baseline to week 12. Additionally, after 12 weeks of treatment, 73 participants in the Vtama cream group achieved complete disease resolution and discontinued treatment with Vtama cream. These participants were followed for an additional 40 weeks and demonstrated a median time to first worsening, defined as a PGA of 2 or greater or categorization as mild, of 114 days.1.2

Contraindications, Warnings and Precautions

There are no contraindications to treatment with Vtama cream. The efficacy and safety of Vtama cream in patients under 18 years of age have not been established. In clinical trials, there were no differences in efficacy, safety or tolerability in elderly patients compared to younger adults. There are insufficient data to determine the risks associated with the use of Vtama cream while breastfeeding or during pregnancy. The most common side effects are contact dermatitis, folliculitis, headache, flu, nasopharyngitis and pruritus.1

References

1. Vtama cream. Prescribing Information. Derma-vant Sciences Inc; 2022. Accessed June 27, 2022. https://www.vtama.com/hcp/PI/

2. FDA approves Dermavant’s Vtama (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first new topical chemical entity launched for psoriasis in the United States in 25 years. Press release. Dermavant Sciences. May 24, 2022. Accessed June 27, 2022. https://www.dermavant.com/us-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/

About the Author

Monica Holmberg, PharmD, BCPS, is a pharmacist in Phoenix, Arizona, and a Pharmacy Times® contributor.

Dermavant Sciences Vtama Cream

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