Zoryve Cream Improves Sleep in Atopic Dermatitis Patients | Fall Clinical Derm 2025

The use of Zoryve (roflumilast) cream improved quality of life, helping patients with atopic dermatitis to reduce sleep disruptions, according to data presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas. Additionally, new long-term data demonstrate that Zoryve cream was well-tolerated and provided continued disease control for patients who switched to twice-weekly treatment.

“Sleep disruption is a persistent and often overlooked but very real daily burden for those impacted by atopic dermatitis, including young children and their families,” Mercedes E. Gonzalez, M.D., medical director of Pediatric Skin Research, said in a news release. Gonzalez is an investigator for the INTEGUMENT-PED clinical trial and lead author of the poster presented at Fall Clinical Dermatology.

Atopic dermatitis is a chronic and recurring inflammatory skin condition that affects about 9.6 million children and 16.5 million adults in the United States.

Developed by Arcutis Biotherapeutics, Zoryve is a topical PDE4 inhibitor. PDE4 is an intracellular enzyme. In people with atopic dermatitis, PDE4 is overly active, which causes increased inflammation and red, itchy skin.

Zoryve is approved in several strengths and formulations to treat different skin conditions. In atopic dermatitis, Zoryve 0.05 is approved as a topical treatment of mild-to-moderate atopic dermatitis in pediatric patients 2 to 5 years of age. Zoryve 0.15 is approved for the same condition in adults and children 6 years of age and older.

In a presentation to investors earlier in the month, Arcutis Biotherapeutics executives said demand for Zoryve has grown, with 1 million prescriptions dispensed. In the second quarter of 2025, Zoryve cream generated $14.6 million in revenue

To assess patients’ sleep, new patient- and caregiver-reported outcomes were used across three phase 3 studies to understand the impact of Zoryve on sleep. Zoryve cream 0.15% and 0.05% improved itch and reduced the negative impact of atopic dermatitis on sleep in patients ≥6 years and young children 2 to 5 years of age.

Zoryve cream was previously shown to reduce itch as measured by the daily Worst Itch Numeric Rating Scale (WI-NRS). Improvements from baseline were greater with the cream compared with vehicle throughout the trials at week 4. On average, there was a greater reduction in mean WI-NRS scores within 24 hours of the first application among patients treated with Zoryve compared with patients treated with vehicle.

Additionally, new data from the phase 3 INTEGUMENT-OLE found that Zoryve cream 0.15% and 0.05% was well-tolerated, decreased signs and symptoms of atopic dermatitis, and maintained or increased improvements through up to 56 weeks of treatment in patients two years of age or older.

As previously reported, Zoryve cream maintained efficacy over time and demonstrated continued improvements in clearance as measured by the Validated Investigator Global Assessment Atopic Dermatitis (vIGA-AD), a 5-point scale to assess the overall severity of atopic dermatitis, and itch as measured by WI-NRS.

The rate of treatment-related adverse events (AEs) during the OLE study was 2.5% in the INTEGUMENT-PED population and 4.7% in the INTEGUMENT-1/2 population.

A separate poster presentation demonstrated that Zoryve cream decreased signs and symptoms of atopic dermatitis in children aged 2 years and older. Importantly, a decrease in the body surface area affected was maintained or improved over 52 weeks of treatment.

Zoryve is also approved as a foam to treat plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older and to treat seborrheic dermatitis in adult and pediatric patients 9 years of age and older. In an investor presentation earlier this month, the company said the demand for the foam formulation, with more than 405,000 prescriptions filled since it was launched in January 2024.