Arcutis Unveils Long-Term Efficacy, Safety For Zoryve Cream In Pediatric Patients With Atopic Dermatitis

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) announced it will present five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference.

Among them is new data from the INTEGUMENT-OLE study, showing that investigational ZORYVE cream 0.05% is safe and effective long-term for children aged 2 to 5 with atopic dermatitis (AD). By Week 4, 30.2% of participants (170 children) who achieved clear skin (vIGA-AD score of 0) transitioned to proactive, twice-weekly treatment.

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.

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Additional data from Arcutis Biotherapeutics shows that both ZORYVE cream 0.15% and investigational 0.05% significantly reduced signs, symptoms, and itch in individuals 2 years and older with atopic dermatitis (AD). Arcutis confirmed that these improvements — reduced body surface area (BSA) affected and clinically meaningful itch relief — were sustained with long-term use, including for those on twice-weekly maintenance therapy.

Key outcomes:

• vIGA-AD 0/1 (clear or almost clear) was achieved by:
  
  • 32.7% of participants aged 6+ and 28.8% of those aged 2–5 at Week 4
  • Increasing to 55.7% and 63.1%, respectively, by Week 52
• Clinically meaningful itch reduction (≥4-point WI-NRS drop):
  
  • 30.9% (6+) and 41.2% (2–5) after 4 weeks
  • Rising to 55.3% and 60.7%, respectively, after 52–56 weeks
• By Week 52, 47.1% (6+) and 40.7% (2–5) had no or minimal itch (WI-NRS of 0 or 1)

The treatment was well tolerated, with low rates of treatment-related adverse events (4.7% for ages 6+ and 2.5% for ages 2–5), and minimal reports of application-site pain (0.5% and 0.7%, respectively).

Price Action: ARQT stock is up 2.59% at $13.86 at the last check on Friday.

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