FDA Approves First-of-Its-Kind Steroid-Free Cream for Psoriasis

Vtama (tapinarof), the first new topical psoriasis drug to get the agency’s okay in 25 years, is set to launch in early June.

Everyday Health Archive
FDA approval of Vtama Tapinarof Cream for Plaque Psoriasis
Unlike topical steroids, Vtama (tapinarof) is safe for long-term use.Adobe Stock; Canva

On May 24, the U.S. Food and Drug Administration (FDA) approved Vtama (tapinarof) cream 1 percent for the treatment of mild, moderate, or severe plaque psoriasis in adults.

It is the first unique topical medication to be launched for psoriasis in 25 years, according to a statement by Dermavant, Vtama’s manufacturer.

Unlike topical steroids, which doctors widely prescribe for psoriasis, Vtama is safe for long-term use.

“There’s tremendous enthusiasm for this product, in part because of the huge need for new treatments for people who have mild psoriasis,” says dermatologist Steven Feldman, MD, PhD, a psoriasis specialist at Atrium Health Wake Forest Baptist in Winston Salem, North Carolina. (Dr. Feldman is not affiliated with Dermavant and did not participate in any of the clinical trials.)

“Those patients just need an effective topical to put on their skin, and many of them are dissatisfied with what’s available. This cream could potentially be very helpful, especially if people are compliant and apply it as directed by their doctor,” says Feldman.

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Vtama Offers an Alternative to Steroid Creams

Topical steroids can have negative side effects, especially when used over a long period of time, says Mark Lebwohl, MD, a professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City and lead author of the phase 3 clinical trials evaluating tapinarof cream.

“There are a lot of drawbacks to using topical steroids long-term. That is particularly true when they are used in areas like the thighs or the armpits — they can cause stretch marks that can be permanent,” says Dr. Lebwohl.

When applied to the face, topical steroids can cause an acne-like rash called perioral dermatitis that can persist for months, Lebwohl says. “They can also thin the skin and cause bleeding under the skin because they can take away the collagen, which is the supporting material around blood vessels,” he adds.

Dermatologists commonly choose not to prescribe topical steroids for use on the face or genitals, Lebwohl says.

There are no such concerns with Vtama. It’s much safer, even if you have to use it long term, Lebwohl says.

“Hopefully, the many people who have been frustrated with psoriasis therapies in the past will take a look at this and maybe come back to the office and talk with their doctor about it,” Feldman notes.

Many People on Vtama Achieved Clear or Almost Clear Skin

The FDA approval of tapinarof was based on data from two identical phase 3 studies that included over 1,000 patients aged 18 to 75 years with plaque psoriasis. Participants were randomly assigned to receive tapinarof cream or placebo once daily for 12 weeks, applied to any lesion anywhere on their body.

At the end of the trials, 36 to 40 percent of patients achieved clear or almost clear skin as measured by their physician global assessment (PGA) score.

Following 12 weeks of treatment, over 90 percent of patients elected to continue taking Vtama for 40 more weeks in the long-term safety study. Of those, almost 10 percent of the patients treated with tapinarof achieved complete disease clearance (all outward signs of psoriasis on the skin disappeared) and so were instructed to stop using the drug.

Those people continued to have clear or almost clear skin for an average of approximately four months after stopping treatment.

Vtama Side Effects Appear to Be Mild

“Overall, the side effect profile (PDF) seems pretty minimal — mostly a little local irritation. It’s the perfect topical: Its anti-inflammatory effects work on the skin, but it doesn’t accumulate in the body or have any internal side effects,” says Feldman.

An estimated 20 percent of study participants reported folliculitis, which is inflammation of the hair follicles — like the small, white-headed pimples that can appear after shaving. Seven percent reported contact dermatitis (also known as a simple rash), and 4 percent reported headache.

Doctors can usually help patients manage these side effects by cutting back on the amount of medication prescribed, Feldman adds.

How Vtama Works in Plaque Psoriasis

Vtama cream works differently than other psoriasis topical treatments. Its active ingredient, tapinarof, is an aryl hydrocarbon (AHR) receptor agonist — AHR is a protein that has a role in regulating metabolism and immunity.

Tapinarof is a potent anti-inflammatory that reduces two sets of cytokines (proteins that affect the immune system) — one of which has a role in regulating the immune response in psoriasis, says Lebwohl.

Interestingly, the aryl hydrocarbon receptor is also the key target for coal tar therapy, which has been used for centuries in treating skin disorders, including psoriasis, says Feldman.

Researchers believe that tapinarof can provide many of the same anti-inflammatory benefits of coal tar without the potential carcinogenic side effects.

Vtama May Be Used by Itself to Treat Mild to Moderate Psoriasis or as an Add-On Therapy in More Severe Disease

If used on its own, Vtama is appropriate for mild disease, but it’s not meant to replace systemic therapy in people with severe disease, says Feldman. Systemic therapies for psoriasis are given by mouth or injection, such as a biologic treatments. “Topical treatment is simply not practical for people with severe plaque psoriasis with large areas of involvement,” he says.

“That being said, even with biologic treatments, a lot of people still have residual spots of psoriasis, so you could use this product along with biologics, just as we sometimes use topical steroids to help clear up the last few spots,” Feldman says.

When Will Vtama Be Available and How Much Will It Cost?

Vtama is expected to be available by prescription beginning in early June. According to a company shareholder presentation (PPT), the out-of-pocket cost for the cream will run $1,325 per tube.

Vtama is more expensive than generic topicals, including steroids and synthetic vitamin D, so it’s possible that insurance companies will require patients to try and fail those other medications first before agreeing to cover Vtama.

There’s no medical reason that people would need to try and fail other medications before moving on to Vtama; if insurers require this, it would be a cost-based decision, Lebwohl notes.