The Food and Drug Administration (FDA) has approved Zoryve™ (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
Zoryve is a once-daily, topical phosphodiesterase-4 (PDE4) inhibitor. The approval was based on data from the multicenter, randomized, double-blind, vehicle-controlled phase 3 DERMIS-1 (ClinicalTrials.gov Identifier: NCT04211363) and DERMIS-2 (ClinicalTrials.gov Identifier: NCT04211389) trials, which evaluated the efficacy and safety of Zoryve in a total of 881 patients with mild to severe plaque psoriasis and an affected body surface area (BSA) of 2% to 20%. Patients were randomly assigned 2:1 to receive either Zoryve or vehicle applied once daily for 8 weeks.
The primary endpoint was the proportion of patients who achieved Investigator Global Assessment (IGA) treatment success at week 8, defined as a score of “clear” (0) or “almost clear” (1) with a 2-grade improvement from baseline.
Results from DERMIS-1 and DERMIS-2 showed that 41.5% and 36.7% of patients treated with Zoryve achieved IGA treatment success at week 8, respectively, compared with 5.8% and 7.1% of patients who received vehicle (P <.0001 in both studies). Among patients with an intertriginous IGA (I-IGA) score of at least 2 at baseline, a greater percentage of patients in the Zorvye arm achieved I-IGA success at week 8 compared with those in the vehicle arm (DERMIS-1: 71.5% vs 13.8%; DERMIS-2: 67.5% vs 17.4%).
Additionally, among patients with a Worst Itch-Numerical Rating Score of 4 or higher at baseline, a greater percentage of patients in the Zoryve arm achieved at least a 4-point reduction in itch at week 8 vs the vehicle group (DERMIS-1: 67% vs 26%; DERMIS-2: 69% vs 33%; P <.0001). Statistically significant improvements in key secondary endpoints, including Psoriasis Area Severity Index-75 (PASI-75) and patient perceptions of signs and symptoms (eg, itching, pain, and scaling, as measured by the Psoriasis Symptoms Diary) were also observed with Zoryve.
As for safety, Zoryve is contraindicated for use in patients with moderate to severe liver impairment (Child-Pugh B or C). The most common adverse reactions reported with treatment included diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections.
“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, FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. “Zoryve is very well tolerated, which is an important consideration for treating a chronic skin disease such as plaque psoriasis.”
Zoryve is supplied in a 60g tube containing 3mg (0.3%) of roflumilast per gram. The product is expected to be available by mid-August.
- FDA approves Arcutis’ Zoryve™ (roflumilast) cream 0.3% for the treatment of plaque psoriasis in individuals age 12 and older. News release. Arcutis Biotherapeutics, Inc. Accessed July 29, 2022. https://www.globenewswire.com/news-release/2022/07/29/2488966/0/en/FDA-Approves-Arcutis-ZORYVE-Roflumilast-Cream-0-3-For-the-Treatment-of-Plaque-Psoriasis-in-Individuals-Age-12-and-Older.html
- Zoryve. Package insert. Arcutis Biotherapeutics, Inc.; 2022. Accessed July 29, 2022. https://www.arcutis.com/wp-content/uploads/USPI-roflumilast-cream-FDAapproved-V1-29Jul2022.pdf