Arcutis to Present New Quality of Life and Long-Term Data with ZORYVE® (roflumilast) Cream 0.15% and 0.05% for the Treatment of Atopic Dermatitis at the Fall Clinical Dermatology Conference

• New data from Phase 3 studies show once-daily ZORYVE cream helped reduce sleep disruptions in individuals with atopic dermatitis aged ≥2 years
• New long-term data demonstrate that ZORYVE cream was well-tolerated and provided continued disease control for individuals who switched to twice-weekly treatment

WESTLAKE VILLAGE, Calif. and LAS VEGAS, Oct. 24, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that new data demonstrating ZORYVE® (roflumilast) cream 0.15% and 0.05% improved quality of life, specifically by helping to reduce sleep disruptions, and provided long-term, durable disease control for individuals with atopic dermatitis aged 2 years and older will be presented at the 2025 Fall Clinical Dermatology Conference, taking place October 23–26, 2025, in Las Vegas.

“We continue to build upon the body of evidence for ZORYVE cream in atopic dermatitis with these presentations at Fall Clinical, including one of the first analyses to report on improvements in sleep as measured through patient reported outcome data. 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 with ZORYVE cream, which is meaningful improvement in children who often have more widespread disease across their smaller bodies,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis Biotherapeutics. “These findings reinforce ZORYVE as an advanced targeted topical treatment and a meaningful alternative to topical corticosteroids—providing effective, well-tolerated therapy for individuals living with atopic dermatitis in need of long-term disease control.”

Roflumilast Cream 0.15% and 0.05% Effects on Sleep in Patients with Atopic DermatitisM. Gonzalez, et al. New patient- and caregiver-reported outcomes on the impact of once-daily ZORYVE cream across three Phase 3, randomized, controlled trials demonstrate that ZORYVE cream 0.15% and 0.05% improved itch and reduced the negative impact of atopic dermatitis on sleep in individuals aged ≥6 years and 2–5 years, respectively, throughout four weeks of treatment compared to vehicle (INTEGUMENT-1/INTEGUMENT-2 aged ≥6 years; n=884 treated with ZORYVE cream 0.15%; n=453 treated with vehicle cream; INTEGUMENT-PED aged 2–5 years; caregiver-applied; n=436 treated with ZORYVE cream 0.05%; n=215 treated with vehicle cream).

Specific results include:

• ZORYVE cream reduced the impact of atopic dermatitis on sleep loss/disturbance for study participants and families as compared to vehicle across multiple patient-reported outcome measurements.1 In addition, the reduced impact of atopic dermatitis on sleep for individuals with atopic dermatitis (and their family, in patients aged ≤17 years) was similar among the ≥6-year and 2–5-year-old age groups.
• As previously reported, ZORYVE cream was also shown to reduce itch as measured by the daily Worst Itch Numeric Rating Scale (WI-NRS).2 Improvements from baseline were greater with ZORYVE cream versus vehicle throughout the trials including at Week 4 (INTEGUMENT-1/2: 2.6 vs 1.6; P