Arcutis publishes long-term ZORYVE safety data for pediatric atopic dermatitis

Arcutis Biotherapeutics Inc. (NASDAQ: ARQT) announced that Pediatric Dermatology published data from a Phase 3 open-label extension study evaluating ZORYVE cream 0.05% in children aged 2 to 5 years with mild-to-moderate atopic dermatitis.

The INTEGUMENT-OLE study included 562 participants who applied ZORYVE cream once daily for up to 56 weeks. Children who achieved clear skin were transitioned to a twice-weekly maintenance regimen. The study's primary endpoint focused on safety assessment.

Treatment-emergent adverse events occurred in 280 participants (49.8%), with most events classified as mild or moderate. The most common adverse events included upper respiratory tract infection (8.7%), nasopharyngitis (5.0%), and fever (5.0%). Serious adverse events occurred in 18 participants (3.2%), none considered treatment-related.

At week 56, 63.1% of participants who completed treatment achieved clear or almost clear skin scores. Among children who continued ZORYVE treatment, 71.9% achieved at least 75% reduction in disease severity scores, while 76.0% of those who switched from placebo to ZORYVE achieved similar improvements.

Of the 170 participants who transitioned to twice-weekly dosing after achieving clear skin, the median duration of disease control was 238 days, according to the company's statement.

The data supported FDA approval of ZORYVE cream 0.05% for pediatric atopic dermatitis in October 2025. ZORYVE cream 0.05% is indicated for mild to moderate atopic dermatitis in pediatric patients aged 2 to 5 years, while the 0.15% formulation is approved for patients 6 years and older.

Atopic dermatitis affects approximately 9.6 million children in the United States, with about 90% of cases developing symptoms by age 5.

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