In May, the Food and Drug Administration (FDA) approved a new prescription cream called Vtama (tapinarof) for the treatment of plaque psoriasis in adults. It’s intended for once-a-day use on affected areas.
The drug is the first in its class—called aryl hydrocarbon receptor agonists—and can be used in sensitive areas like the face, neck, and groin.
“As the first and only approved drug in its class in the U.S., the FDA’s approval of Vtama cream provides an effective new non-steroidal treatment option for millions of adults living with plaque psoriasis,” Todd Zavodnick, chief executive officer of Dermavant Sciences, which manufactures the drug, said in a statement.
There are other topical treatments available for psoriasis, but the most effective and widely used ones contain corticosteroids to control inflammation. Steroids have drawbacks, like leading to thinning of the skin, pigmentation changes, easy bruising, broken blood vessels, and redness. And they shouldn’t be used on sensitive skin areas. Topical steroids also tend to lose effectiveness over time, which limits their usefulness.
Having an effective non-steroid topical drug is important, Linda Stein Gold, MD, vice president of the American Academy of Dermatology and a co-author of two Vtama studies, told Verywell. Stein Gold served as a consultant for Dermavant Sciences.
“Topical steroids are an important component of treatment for psoriasis, and I think they always will have a role, but they don’t always get patients under control for the long term,” Stein Gold said, noting many steroid prescriptions can only be used for up to two to four weeks. “They do work very quickly, so that’s a good thing, but there are limitations on use.”
While researchers aren’t completely sure why Vtama works, it appears to modulate the immune system and normalize the skin barrier.
Three clinical trials have shown that it is effective against psoriasis with mild to moderate side effects. It’s also safe for long-term use.
Patients who had taken part in 12-week placebo-controlled clinical trials comparing cream with the drug to placebo cream were then enrolled in a 40-week trial with no placebo group. In the 12-week studies, 40% of patients had clear or almost clear skin with Vtama, compared to 6% of those given the cream with no drug. In the 40-week trial, almost 41% of patients had complete clearance of their psoriasis plaques, and nearly 60% had improvement.
Vtama also appears to send psoriasis into remission. Patients were able to go without the drug for about four months after they stopped using it and still have clear or almost clear skin, Stein Gold said.
“This is really the first time we’re talking to patients about potentially having a drug holiday,” she said.
In clinical trials, side effects of Vtama were generally mild to moderate, including inflamed hair follicles, nose and throat irritation, contact dermatitis, itching, headache, and flu.
A general physician can diagnose psoriasis or may refer you to a dermatologist for diagnosis and treatment.
Vtama is available by prescription only and comes in a 60-gram tube. A tube should last about a month, according to Stein Gold, and costs about $1,400 out of pocket.
Health insurance companies may require that you try other topical medications before approving the use of Vtama. But most psoriasis patients have already tried other topical medications that didn’t work or that have lost effectiveness already, she added.