Arcutis To Present New Long-Term Results Of ZORYVE Cream at 2025 Revolutionizing Atopic Dermatitis Conference

Author: Benzinga Newsdesk | June 06, 2025 08:03am

• New data from the Phase 3 INTEGUMENT-OLE long-term open label study show durable improvement in the signs and symptoms of atopic dermatitis (AD), including almost half of participants achieving no or minimal itch with ZORYVE cream 0.15% or ZORYVE cream 0.05%
• New data demonstrate that for children ages 2 to 5 who achieved disease clearance and switched to proactive twice-weekly application of investigational ZORYVE cream 0.05%, the median duration of disease control was 238 days
• Consistent efficacy, safety, and tolerability profile observed with ZORYVE cream

WESTLAKE VILLAGE, Calif., June 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will present five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, which is taking place in Nashville, TN, from June 6-7, 2025.

Importantly, the Company will present new data from its INTEGUMENT-OLE study demonstrating the long-term safety and durable efficacy of investigational ZORYVE cream 0.05% in children ages 2 to 5 with AD, consistent with previous studies. Starting at Week 4 of INTEGUMENT-OLE, participants who achieved a validated Investigator Global Assessment (vIGA-AD) score of clear (0), switched to proactive twice-weekly application (170 participants; 30.2% of study population). For participants who switched to twice-weekly application, the median duration of disease control (maintaining vIGA-AD of clear or almost clear with adequate control of signs and symptoms on the twice-weekly schedule application) was 238 days (34 weeks), consistent with the 281 days observed for adults and children down to age 6 who used twice-weekly dosing.

Additional poster presentations will present data demonstrating that in individuals 2 years of age and older with AD, ZORYVE cream 0.15% or investigational ZORYVE cream 0.05% decreased signs and symptoms of AD — including a clinically meaningful improvement in itch as well as reduction in mean percent body surface area (BSA) affected over time — and these improvements were maintained or improved further with long-term treatment, including in those who switched to twice-weekly application. Specifically, at the end of the parent studies (Week 4), 32.7% of participants 6 years and over, and 28.8% of participants 2 to 5 years achieved vIGA-AD 0/1, which improved to 55.7% and 63.1%, respectively, by the end of the INTEGUMENT-OLE study (Week 52), amounting to up to 56 weeks of treatment. In addition, itch was improved, with 30.9% of participants 6 years and over and 41.2% of participants 2 to 5 years achieving clinically meaningful reduction in Worst Itch Numeric Rating Scale (WI-NRS) (≥4-point reduction) at the conclusion of the parent studies, improving to 55.3% and 60.7%, respectively, after up to 56 weeks of treatment. Substantial proportions of participants also achieved no or minimal itch by end of treatment (47.1% of those aged ≥6 years and 40.7% of those aged 2–5 years as measured by WI-NRS of 0 or 1).

Posted In: ARQT