Arcutis Reports Positive Long-Term Results for Roflumilast Cream in Young Children with Atopic Dermatitis

Arcutis Biotherapeutics, Inc., a biopharmaceutical company specializing in immuno-dermatology, has revealed promising results from their INTEGUMENT-OLE long-term study. This research focuses on the efficacy and safety of once-daily roflumilast cream 0.05% for treating mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The findings demonstrated robust and sustained efficacy over a 56-week period, with no new safety concerns arising.

The study underscores that roflumilast cream is well-tolerated among young children, maintaining safety and efficacy throughout the treatment. A notable 71.9% of participants who continued from the previous INTEGUMENT-PED study experienced a 75% improvement from their baseline in the Eczema Area and Severity Index (EASI-75) by week 56.

Adelaide Hebert, MD, a professor of dermatology and pediatrics at UTHealth Houston and an investigator for the INTEGUMENT trial, emphasized the importance of choosing treatments for young children that provide rapid relief and are safe for long-term use. She noted that the study's results build upon the positive findings from the Phase 3 trial, which initially demonstrated rapid efficacy within the first four weeks. The long-term study further confirmed the enduring effectiveness and safety of the roflumilast cream.

In addition to the EASI-75 results, 53.8% of participants from the INTEGUMENT-PED study achieved a validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success at 56 weeks. This success was defined by a vIGA-AD score of 0 or 1 plus a two-grade improvement from baseline. The study reinforced the positive safety profile seen in the initial four-week trial, with no new safety issues over the extended period. Adverse events were generally mild to moderate, with the most common being upper respiratory tract infection, nasopharyngitis, pyrexia, influenza, COVID-19, and otitis media. Only 3% of the participants discontinued due to adverse effects.

Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, highlighted that roflumilast cream is formulated to avoid sensitizing excipients and irritants that can disrupt the skin barrier. He expressed enthusiasm about the study results, which bolster the company's ZORYVE product portfolio and demonstrate the cream's long-term efficacy, safety, and tolerability for treating pediatric AD. Burnett believes that, if approved, roflumilast cream 0.05% could provide both immediate and long-term management for this challenging skin condition, expanding treatment options to very young children.

Arcutis plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 for the use of roflumilast cream 0.05% in children ages 2-5. Currently, ZORYVE® (roflumilast) cream 0.15% is approved for treating mild to moderate AD in patients aged six and older.

The INTEGUMENT-OLE study, a Phase 3 multicenter open-label extension, evaluated the long-term safety of roflumilast cream 0.15% in adults and children aged six and older, and roflumilast cream 0.05% in children aged 2 to 5. A total of 562 individuals participated after completing the INTEGUMENT-PED Phase 3 trial. Participants used roflumilast cream 0.05% as a monotherapy, with no rescue treatments allowed. From week 4, those achieving a vIGA-AD score of '0-Clear' switched to twice-weekly maintenance dosing, with the possibility of resuming once-daily dosing if needed.

Atopic dermatitis, the most common type of eczema, affects millions of children and adults in the U.S. It is characterized by a defective skin barrier, leading to immune reactions and inflammation, resulting in a red, itchy rash. Given the prevalence of AD in young children, safety is a crucial factor in treatment choices.

Roflumilast cream is a next-generation topical phosphodiesterase-4 (PDE4) inhibitor, targeting an enzyme involved in inflammatory responses. Various formulations are already FDA-approved for treating plaque psoriasis and mild to moderate AD in older children and adults.

Arcutis Biotherapeutics champions innovation in dermatology, aiming to address pressing needs in immune-mediated skin diseases. With multiple FDA-approved products and a robust pipeline, Arcutis continues to develop therapies for various inflammatory dermatological conditions.