The U.S. Food and Drug Administration (FDA) approved Zoryve (roflumilast) cream 0.3 percent for the treatment of plaque psoriasis, including intertriginous areas (where skin rubs against other skin) in people 12 years of age and older, according to a press release issued by Arcutis, the manufacturer of the drug. Once-daily Zoryve is the first and only approved topical phosphodiesterase-4 (PDE4) inhibitor, the first and only FDA-approved steroid-free cream in its class.
PDE4 inhibitors suppress the immune system by reducing the action of an overactive enzyme (phosphodiesterase 4), thereby reducing inflammation.
“It is always great to have another topical option to treat psoriasis, so this approval is exciting,” says Marisa Garshick, MD, a board-certified dermatologist at MDCS Dermatology in New York City. Zoryve will be a good choice for those patients who prefer to avoid a topical steroid, she adds.
This approval offers yet another steroid-free option for people with plaque psoriasis; in May, the FDA approved Vtama (tapinarof) cream 1 percent for topical treatment of mild, moderate, or severe plaque psoriasis in adults.
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Nearly Half of Patients Treated With Zoryve Achieved Clear or Almost Clear Skin
FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled (Zoryve was compared to a placebo or “dummy” cream) trials that included a total of 881 people, called the DERMIS1 and DERMIS2 studies, presented at the 2021 Clinical Dermatology Conference in Las Vegas, Nevada.
The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear skin with at least a 2-grade improvement from baseline, and at least a 2-grade IGA score improvement from baseline at eight weeks. In the 2 trials, 42.4 percent and 37.5 percent of the patients treated with Zoryve achieved an IGA success rate, compared with 6.1 percent and 6.9 percent in the control groups, respectively.
Nearly 3 in 4 people (73.5 percent) completed 52 to 64 weeks of treatment, and fewer than 1 percent of participants discontinued because the medication didn't work.
Zoryve Helped Relieve Itching
In addition to clearing the skin, Zoryve improved the severity and impact of itch. Of participants with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or higher at baseline, 2 out of 3 people using Zoryve achieved at least a 4-point reduction at week 8. The WI-NRS is a questionnaire that asks patients to rate their itch from 0 (no itch) to 10 (worst imaginable itch) in the past 24 hours, according to an article published October 23, 2021, in BMC Health and Quality of Life Outcomes.
Zoryve Gives People With Plaque Psoriasis Another Steroid-Free Treatment Option
While topical steroids are a very effective option for psoriasis, their use over time should be limited, says Dr. Garshick. “There are certain locations on the body, including the face and skin folds, where their use should be limited to prevent thinning of the skin,” she adds.
Zoryve is the only topical that has data specifically focusing on the treatment of intertriginous plaques (those found in skin folds), said Frank Watanabe, the president and CEO of Arcutis, in the statement. For people who have psoriasis in those areas, which can include areas such as the underarms, under the breasts, or the groin area, Zoryve can be a safe and effective option, says Garshick.
Unlike steroids, there is no restriction on how long Zoryve can be used to treat plaque psoriasis, according to the approval statement. When used chronically (over a long period of time), topical steroids can cause stretch marks in areas like the thighs or the armpits, according to the American Academy of Dermatology (AAD).
In general, Zoryve is safe and easy to tolerate for those with psoriasis, says Garshick. The most commonly reported side effects in people using Zoryve were diarrhea (3.1 percent), headache (2.4 percent), insomnia (1.4 percent), nausea (1.2 percent), application site pain (1 percent), upper respiratory tract infection (1 percent), and urinary tract infection (1 percent).
How Much Will Zoryve Cost?
The current wholesale acquisition cost (WAC) pricing is $825 for a 60 gram (g) tube of Zoryve, according to Arcutis. The actual cost to the patient will depend on insurance coverage.
The company offers a savings program; people with commercial insurance that provides Zoryve coverage will pay $25 a tube, and those with commercial insurance that does not cover Zoryve will pay $75 a tube. Financially eligible patients who don’t have insurance or who are underinsured may access the cream through the Arcutis Cares Patient Assistance Program.