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The FDA approved the topical PDE4 inhibitor roflumilast (Zoryve) for mild-to-severe plaque psoriasis, including for intertriginous areas, in patients ages 12 years and older, Arcutis Biotherapeutics .

Roflumilast cream 0.3% is the first FDA-approved topical PDE4 inhibitor and contains the same active ingredient as oral roflumilast (Daliresp), which is approved for severe chronic obstructive pulmonary disease. The once-daily treatment for plaque psoriasis has no limitations on duration of use.

"In multiple clinical trials, Zoryve was proven to be safe and effective, with improvements in disease clearance in hard-to-treat areas like knees and elbows, as well as in sensitive areas such as the face, genitalia, and intertriginous areas," said Mark Lebwohl, MD, of the Icahn School of Medicine at Mount Sinai in New York City, in a statement from Arcutis. "Zoryve is very well tolerated, which is an important consideration for treating a chronic skin disease such as plaque psoriasis."

Principal support for the approval came from the randomized, vehicle-controlled, phase III clinical trials and . In both trials, significantly more patients achieved Investigator Global Assessment (IGA) success at week 8 with roflumilast (42% and 37% vs 6% and 7% for vehicle, P<0.0001). More than twice as many patients randomized to topical roflumilast had at least a four-point reduction in itch score after 8 weeks (P<0.0001).

With respect to difficult-to-treat intertriginous psoriasis, four times as many patients randomized to roflumilast achieved IGA success at 8 weeks as compared with vehicle (72% vs 14%, 68% vs 17%, P<0.0001). The two clinical trials were the first to demonstrate superiority of a treatment specifically for intertriginous plaque psoriasis.

In both clinical trials, key secondary outcomes improved significantly more with roflumilast versus the control arm, including Psoriasis Area and Severity Index-75 and patient-reported symptoms. Significant improvements in psoriasis signs and symptoms with roflumilast became apparent during the first 4 weeks.

Among 239 patients who continued topical roflumilast for 52 weeks, 45% achieved IGA 0/1 ratings (clear/almost clear).

The most common adverse events that occurred more often with topical roflumilast than with vehicle were diarrhea (3%), headache (2%), and insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection (1% each).

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