(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT), on Friday announced it will present five poster presentations at the 2025 Revolutionizing Atopic Dermatitis or RAD Conference, including new long-term data from the Phase 3 INTEGUMENT-OLE study evaluating ZORYVE or roflumilast cream for atopic dermatitis or AD.
New results from the INTEGUMENT-OLE open-label extension study demonstrated that ZORYVE cream 0.15 percent and investigational ZORYVE 0.05 percent provided durable improvements in AD signs and symptoms for both children and adults.
Among children aged 2 to 5 who achieved disease clearance and transitioned to twice-weekly proactive application of ZORYVE 0.05 percent, the median duration of disease control was 238 days. For older patients, the duration reached 281 days.
By Week 52 of the study, 63.1 percent of participants aged 2-5 and 55.7 percent aged 6 and older achieved a vIGA-AD score of 0 or 1 with over half experiencing clinically meaningful reductions in itch.
Additionally, nearly half of participants reported no or minimal itch by the end of treatment.
ZORYVE was well tolerated across age groups, with low rates of treatment-related adverse events — 2.5 percent in children 2 to 5 years and 4.7 percent in patients aged 6 and older.
The findings support the long-term use of ZORYVE as a steroid-free treatment option, particularly in pediatric patients with sensitive skin.
ZORYVE 0.15 percent is currently approved by the FDA for atopic dermatitis in patients aged 6 and older.
The 0.05 percent formulation is under review by the FDA for children aged 2 to 5, with a PDUFA action date set for October 13, 2025.
The company's presentations at RAD 2025 reinforce ZORYVE's potential as a safe, effective, long-term topical treatment option for managing chronic AD in all age groups.
Currently, ARQT is trading at $13.82, up by 2.33 percent on the Nasdaq.
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