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

Arcutis Biotherapeutics, Inc. 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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