- Federal regulators have approved a new medication for the treatment of plaque psoriasis in adults.
- Tapinarof cream 1% is a steroid-free topical cream applied once a day.
- Experts say the cream provides a non-steroidal alternative for dermatologists to prescribe.
The Food and Drug Administration (FDA) has approved a new topical cream for a type of psoriasis.
Tapinarof cream 1% is a steroid-free topical cream applied once a day. It treats mild, moderate, or severe plaque psoriasis in adults.
“As a dermatologist, I always welcome any new treatment option for my patients with plaque psoriasis. Tapinarof 1% cream is the latest breakthrough – a first in class medication that is entirely different from what is currently available on the market,” said Dr, Brian Toy, an attending dermatologist at Providence Mission Hospital and a clinical professor in the School of Medicine at the University of Southern California.
The FDA based their approval of tapinarof on three phase-three clinical trials, called Psoaring 1, Psoaring 2, and Psoaring 3, an open-label extension study.
About 1,000 adults between 18 and 75 enrolled in Psoaring 1 and Psoaring 2. The participants were randomized to use tapinarof or a placebo for up to 12 weeks. The primary endpoint was to have participants achieve the Physician Global Assessment score of “clear” or “almost clear” and improve at least two grades from their baseline.
At the end of 12 weeks, 36 percent of participants from Psoaring 1 and 40 percent of those from Psoaring 2 reached the primary endpoint, compared to 6 percent of the placebo group.
People taking tapinarof, which is sold under the brand name VTAMA cream, showed a significant improvement in all secondary endpoints versus vehicle from baseline at week 12, including a 75 percent or greater improvement in the Psoriasis Area and Severity Index.
In addition, 73 study participants who achieved the primary outcome continued to Psoaring 3, a 40-week extension study. During this phase, the researchers discontinued treatments. The participants retained their Physicians Global Assessment scores of 0 or 1 for around four months.
Adverse events were mild to moderate and included:
“The efficacy of this new drug is promising,” Toy told Healthline. “And the side effects appear limited to potential folliculitis, an acne-like rash. I look forward to prescribing it for my psoriasis patients and hope its efficacy and safety can match what was demonstrated in the clinical trials. The jury is still out, but I am cautiously optimistic.”
At the end of the study, 599 participants completed questionnaires. About 86 percent felt they could easily manage their psoriasis with tapinarof. About 84 percent were satisfied with the results and about 82 percent said tapinarof was more effective than previous topical treatments they had used.
The cream can be used on all body areas, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae.
“In the past decade, we have seen an exponential growth in the number and variety of treatment options for plaque psoriasis,” said Dr. M. Laurin Council, FAAD, FACMS, an associate professor in the Division of Dermatology at the Washington University School of Medicine in St. Louis.
“Traditionally, many topical agents used to treat psoriasis are steroid agents,” she told Healthline. “These must be avoided in certain areas due to side effects and absorption. Topical tapinarof is a nonsteroidal agent and has the advantage of topical application, which can be tailored to affected areas and carries a limited risk of side effects. It has the advantage of being used in some areas where steroid medications should be avoided.”
A new oral medication for psoriasis is now in the approval process.
Deucravacitinib, which is being developed by Bristol Myers Squibb, is a once-daily prescription medication.
Participants received 6mg per day during clinical trials. Company officials said the drug maintained efficacy for up to two years of treatment.
Bristol Myers Squibb has submitted their application to the FDA and expects to hear back by September.