The Food and Drug Administration (FDA) has approved Vtama® (tapinarof cream) for the topical treatment of plaque psoriasis.
Vtama contains tapinarof, an aryl hydrocarbon receptor agonist. While the exact mechanism by which the product exerts its therapeutic effect in psoriasis is unknown, it is believed that tapinarof modulates the expression of proinflammatory cytokines, including interleukin-17, as well as skin barrier protein expression.
The approval was based on data from 2 identical phase 3 studies, PSOARING 1 (ClinicalTrials.gov Identifier: NCT03956355) and PSOARING 2 (ClinicalTrials.gov Identifier: NCT03983980), which assessed the efficacy and safety of tapinarof in 1025 patients aged 18 to 75 years with plaque psoriasis. Patients were randomly assigned 2:1 to receive tapinarof cream or vehicle once daily for 12 weeks, applied to any lesion regardless of anatomic location.
The primary end point for both studies was the proportion of patients with a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline to week 12.
Results from PSOARING 1 and 2 showed that 36% and 40% of patients treated with tapinarof, respectively, met the primary end point at week 12 compared with 6% and 6% for vehicle (both P <.0001).
Following 12 weeks of treatment, 73 tapinarof-treated patients achieved complete disease clearance (PGA 0) and had tapinarof withdrawn. These patients were followed for up to 40 additional weeks with a median time to first worsening (PGA ≥2 [“mild”]) of 114 days (95% CI, 85-142).
“We are proud to have developed a topical treatment in Vtama cream that provides not only efficacy over 52 weeks but can also be used on all body areas, including on sensitive locations, such as face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “An approximately 4 month off-treatment remittive effect (median time to first worsening), leads us to believe that Vtama cream has the potential to become the preferred topical option for this chronically underserved patient population and among the physicians who treat them.”
The most common adverse reactions with treatment include folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
The safety and efficacy of Vtama cream have not been established in pediatric patients under 18 years of age.
Vtama is supplied in a 60g tube. Each gram of cream contains 10mg of tapinarof.
- FDA Approves Dermavant’s Vtama® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the U.S. in 25 years. News release. May 24, 2022. https://www.businesswire.com/news/home/20220519005802/en/FDA-Approves-Dermavant%E2%80%99s-VTAMA%C2%AE-tapinarof-cream-1-for-the-Treatment-of-Plaque-Psoriasis-in-Adults-First-Topical-Novel-Chemical-Entity-Launched-for-Psoriasis-in-the-U.S.-in-25-Years
- Vtama. Package insert. Dermavant Sciences; 2022. Accessed March 24, 2022. https://dermavantnowapproved.21gms.com/docs/DMVT_VTAMA_PI.pdf