Arcutis Announces Publication Of Positive Data From INTEGUMENT-PED Trial Evaluating ZORYVE

Arcutis Biotherapeutics

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(RTTNews) - Arcutis Biotherapeutics, Inc.?(ARQT), Monday announced that Pediatric Dermatology published online positive results from INTEGUMENT-PED, the pivotal phase 3 randomized vehicle-controlled trial evaluating the efficacy and safety of?ZORYVE (roflumilast) cream 0.05%?as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis (AD) in children 2 to 5 years old.

The study found that treatment with investigational once-daily ZORYVE cream 0.05% resulted in significant improvements across multiple efficacy endpoints, including achieving a statistically significant improvement in the primary efficacy endpoint of IGA Success, as well as statistically significant improvements in additional endpoints, including 75% improvement in the Eczema Area and Severity Index (EASI-75) and Worst Itch Numeric Scale (WI-NRS) at Week 4. The data also show improvement in itch (pruritus) was observed as early as 24 hours after first application.

"AD is a chronic, inflammatory skin disease affecting 1.8 million children ages 2 to 5 in the United States with burdensome symptoms that often result in impaired quality of life for both patients and their caregivers," said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and lead author on the publication.?"Results from the INTEGUMENT-PED trial demonstrate that ZORYVE cream 0.05% can quickly and reliably improve the symptoms of AD, especially itch. The publication of these results and the entire clinical development program highlight that ZORYVE cream 0.05%, if approved, could fill a significant gap in the current treatment landscape for a once-daily steroid-free topical therapy that is appropriate for both the short and long-term management of AD, key concerns for young patients and their caregivers."