Arcutis Biotherapeutics presents quality of life, long-term data on ZORYVE

Arcutis Biotherapeutics (ARQT) announced that new data demonstrating ZORYVE 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. Roflumilast Cream 0.15% and 0.05% Effects on Sleep in Patients with Atopic Dermatitis: 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 greater than or equal to6 years and 2-5 years, respectively, throughout four weeks of treatment compared to vehicle. 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 was similar among the greater than or equal to6-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. Improvements from baseline were greater with ZORYVE cream versus vehicle throughout the trials including 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 to patients treated with vehicle in both INTEGUMENT-1/2 and INTEGUMENT-PED. ZORYVE was well tolerated, with treatment-related adverse events and serious AEs reported by less than or equal to6% and less than1% of patients, respectively, in the ZORYVE group, from any of the studies. Application-site pain AEs were reported for 13 of individuals in the ZORYVE group in INTEGUMENT-1/2 and 7 of individuals in INTEGUMENT-PED. Once-Daily Roflumilast Cream 0.15% and 0.05% Improve Atopic Dermatitis Signs and Symptoms that Can be Maintained with Proactive Twice-Weekly Treatment: Results From the 52-Week Phase 3 INTEGUMENT-OLE Trial in Patients Aged greater than or equal to2 Years: New long-term data from INTEGUMENT-OLE, a 52-week, Phase 3, multicenter, open-label extension trial in individuals aged greater than or equal to2 years with mild-to-moderate atopic dermatitis show that ZORYVE cream 0.15% and 0.05% were well tolerated, decreased signs and symptoms of atopic dermatitis, and maintained or increased improvements through up to 56 weeks of treatment in individuals aged greater than or equal to2 years. Study participants previously completed one of the pivotal Phase 3 trials, INTEGUMENT-1 or INTEGUMENT-2 or INTEGUMENT-PED. Key results include: As previously reported, the data demonstrate that, even in young children 2-5 years of age who have a higher body surface area affected, the decrease in mean BSA affected through 4 weeks of treatment with ZORYVE cream in pivotal Phase 3 trials was maintained and improved further over an additional 52 weeks of treatment in the OLE study. Starting at Week 4 of INTEGUMENT-OLE, participants who achieved a vIGA-AD3 score of ‘Clear’, switched to proactive twice-weekly application. For participants who switched to twice-weekly application, the median duration of disease control was 238 days in children 2-5 and 281 days in adults and children 6 years of age and older. As previously reported, ZORYVE cream maintained efficacy over time and demonstrated continued improvements in clearance as measured by vIGA-AD and itch as measured by WI-NRS. At 56 weeks, the percent of patients achieving vIGA-AD ‘Clear’ or ‘Almost Clear’ were 55.7% in the INTEGUMENT-1/2 populations and 63.1% in the INTEGUMENT-PED population, compared to 41.3% and 40.3% at Week 4 of the OLE study, respectively. At 56 weeks, the percent of patients achieving WI-NRS rating of no/minimal itch with ZORYVE cream were 41.4% in the INTEGUMENT-1/2 population and 40.7% in the INTEGUMENT-PED population, compared to 25.5% and 25.5% at Week 4 of the OLE study, respectively. The rate of treatment related adverse events during the OLE study was 2.5% in the INTEGUMENT-PED population and 4.7% in the INTEGUMENT-1/2 population, and application-site pain AEs less than1% across both populations.