Arcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting - Seite 2

“For the pediatric patient population, tradeoffs between efficacy, tolerability, and safety are critical aspects of atopic dermatitis treatment decisions. In addition, tolerability is paramount, and if there are problems with tolerability, there is a hurdle for adherence,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, and study investigator. “These tradeoffs are further amplified in young children, which is why having a well-designed formulation that doesn’t disrupt the skin barrier benefits the patient and decreases the concerns of caregivers. The results from this study of once-daily application of roflumilast cream 0.05% in patients 2 to 5 years old are consistent with the findings from the INTEGUMENT-1 and INTEGUMENT-2 studies of patients down to the age of 6. If approved, this profile will be a welcome, easily adopted option for patients and clinicians alike.”

Roflumilast cream is an investigational once-daily, steroid-free topical cream formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area of 22% overall, and a range from 3% to 82%. The data reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.

New data highlighted in the session included 35.4% of children treated with roflumilast cream achieved vIGA-AD clear (0) or almost clear (1) compared to 14.6% of vehicle (P<0.0001) at the end of the study (Week 4), with improvements seen as early as Week 1. In addition, the data show improvement in itch with roflumilast cream 0.05% as early as 24 hours following first application, based on LS mean change from baseline in daily WI-NRS score (P=0.0014 vs vehicle).

“We are pleased to present these data from our pivotal Phase 3 INTEGUMENT-PED study of roflumilast cream in children aged 2 through 5, which provide strong support for the safety and efficacy in this young age group and are consistent with the results with roflumilast cream across our atopic dermatitis development program,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “Roflumilast cream 0.05% was also shown to be well-tolerated in young children as demonstrated by both investigator and patient-reported outcomes. We know that there is a significant unmet need for safe, tolerable, and efficacious topical treatments for this young patient population, and look forward to providing meaningful innovation through the continued development of roflumilast cream.”