Roflumilast Cream Demonstrates Efficacy, Safety Treating Mild to Moderate Atopic Dermatitis in Children

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Long-term results from the INTEGUMENT-OLE study found that Arcutis Biotherapeutics’ roflumilast cream 0.05% demonstrated a durable efficacy and safety profile treating mild to moderate atopic dermatitis (AD) in children aged two to five years. According to the company, the study also found that the cream improved efficacy results over time from baseline in Eczema Area and Severity Index (EASI-75) after 56 weeks.¹

“When choosing a therapy for very young children, health care providers and caregivers are looking for treatments that provide both rapid relief and are well-tolerated and suitable for long-term use,” said INTEGUMENT trial investigator Adelaide Hebert, MD, professor, dermatology and pediatrics, UTHealth Houston, in a press release. “These results build upon the findings from the Phase III trial of roflumilast cream 0.05% that demonstrated rapid efficacy within the first 4 weeks of treatment, and further showed long-term durable efficacy and tolerability of investigational roflumilast cream, with continued improvement over the course of the long-term study.”

The Phase III multicenter, open-label extension INTEGUMENT-OLE trial evaluated the long-term safety of roflumilast cream 0.15% in adults and children aged 6 years and older with AD and roflumilast cream 0.05% in children ages 2 to 5 years. Amid completion of the INTEGUMENT-PED Phase III study, 562 patients were enrolled in the INTEGUMENT-OLE clinical trial. The primary endpoint was to assess the long-term safety of the cream, with secondary endpoints that included Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) of 0 or 1 at each assessment, vIGA-AD success defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, and EASI score over time.

Results found that 71.9% of participants achieved a 75% EASI improvement after 56 weeks. Additionally, 53.8% of participants who rolled over from the roflumilast cream treatment arm in INTEGUMENT-PED achieved a vIGA-AD of 0 or 1 plus a 2-grade improvement from baseline at 56 weeks.

The incidence of adverse events (AEs) was found to be minimal, with a majority being mild to moderate in nature. The most frequently reported AEs included upper respiratory tract infection, nasopharyngitis, pyrexia, influenza, COVID-19, and otitis media, with only 3% of trial participants discontinuing treatment as a result.¹

“Roflumilast cream is uniquely formulated with the AD patient in mind, to deliver treatment without sensitizing excipients and irritants, which can often disrupt the skin barrier. We are excited by these results, which reinforce the strength of our Zoryve product portfolio and specifically demonstrate the long-term efficacy, safety and tolerability profile of our once-daily roflumilast cream for the treatment of pediatric AD,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis, in the press release. “Based on these positive results, we are convinced that, if approved, roflumilast cream 0.05% can help provide immediate as well as long-term management of this burdensome skin condition, expanding the treatment population to children down to age 2.”

According to the Asthma and Allergy Foundation of America, AD occurs in 7.3% of adults in the United States. Of those with AD, 40% have moderate or severe symptoms.²

Arcutis plans to submit a supplemental New Drug Application to the FDA in early 2025 to expand the indication of roflumilast cream to children as young as 2 years of age. Currently, Zoryve (roflumilast) cream 0.15% is approved for the topical treatment of mild to moderate AD in adults and pediatric patients down to 6 years of age.¹

References

1. Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.05% Show Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis. Arcutis. August 28, 2024. Accessed August 29, 2024. https://www.arcutis.com/arcutis-announces-positive-long-term-results-of-roflumilast-cream-0-05-show-durable-and-improved-efficacy-over-time-and-favorable-safety-profile-in-treatment-of-children-aged-2-to-5-with-mild-to-moder/

2. Atopic Dermatitis in America. AAFA. Accessed August 29, 2024. https://aafa.org/asthma-allergy-research/our-research/atopic-dermatitis-in-america/