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FDA Approves Vtama, a Steroid-Free Topical Cream for Psoriasis

Posted on June 21, 2022
Medically reviewed by
Ariel D. Teitel, M.D., M.B.A.
Article written by
Maureen McNulty

  • The U.S. Food and Drug Administration (FDA) has approved a topical cream called Vtama — a formulation of tapinarof — as a treatment for plaque psoriasis.
  • Tapinarof is the first steroid-free topical medication for psoriasis, giving people with the condition access to a new type of treatment option.
  • Clinical trials show that tapinarof works long term and comes with minimal side effects.

The FDA approved a new medication called Vtama this past May for the treatment of plaque psoriasis. Approved for adults with mild, moderate, or severe plaque psoriasis, this is the first new type of topical psoriasis drug to be approved in the United States in 25 years. The cream is applied directly to the skin and can be used anywhere on the body.

Unlike other available topical psoriasis medications, tapinarof is not a steroid. Rather, it’s an aryl hydrocarbon receptor (AhR) agonist — a new type of medication that activates a protein called AhR in order to fight plaque psoriasis on two fronts. In immune cells, AhR turns off genes related to inflammation. In skin cells, it boosts the expression of genes that normalize skin barrier function. Whereas steroids can often only be used in the short term, tapinarof can be used for unlimited periods of time.

Clinical Trial Results

The FDA approval was based on clinical studies that found that tapinarof lessened psoriasis disease severity. Two identical clinical trials, PSOARING 1 and PSOARING 2, reported that 35 percent to 40 percent of study participants were clear or almost clear of psoriasis symptoms after three months of using the drug.

Researchers then conducted another follow-up study called PSOARING 3 to assess the long-term effects of tapinarof. After taking the drug for up to one year, more than 40 percent of study participants experienced a complete clearing of symptoms at some point while on the medication. After the participants stopped using tapinarof, it took an average of four months for symptoms to return.

Study participants reported high levels of satisfaction while using the drug, according to drug manufacturer Dermavent. About 82 percent of participants said they preferred tapinarof to other topical treatments they’d used in the past. Additionally, nearly 86 percent believed that this treatment could help them easily manage their psoriasis, and around 83 percent said they would use tapinarof cream in the future.

Study participants reported some side effects, although these were usually mild or moderate and primarily affected the area of skin in which the cream was applied. According to the FDA, the most common side effects include:

  • Folliculitis (inflammation or infection of the hair follicles, leading to small red or white bumps)
  • Contact dermatitis (a skin rash that is discolored, peeling, itchy, or burning)
  • Itchy skin
  • Nasopharyngitis (swelling or inflammation in the nose or throat)
  • Influenza (the flu)
  • Headache

Dr. Mark Lebwohl, professor at the Icahn School of Medicine at Mount Sinai in New York and one of the researchers leading the tapinarof clinical trials, expressed optimism for the new treatment. “Following 20-plus years of minimal innovation in the topical psoriasis treatment space, I believe the approval of Vtama cream is an important step in establishing a new treatment option for adults with mild, moderate, and severe plaque psoriasis,” Dr. Lebwohl said in a press release. “As a clinician, I’m excited to finally have a versatile, once-daily, steroid-free topical treatment that is backed by extensive clinical trial data supporting its favorable safety and efficacy profile.”

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What do you think about this new medication? Share your experience in the comments below, or start a conversation by posting on your Activities page.

All updates must be accompanied by text or a picture.
Ariel D. Teitel, M.D., M.B.A. is the clinical associate professor of medicine at the NYU Langone Medical Center in New York. Review provided by VeriMed Healthcare Network. Learn more about him here.
Maureen McNulty studied molecular genetics and English at Ohio State University. Learn more about her here.

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