Arcutis Presents Long-Term Data on Roflumilast Cream for Atopic Dermatitis

At the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, Arcutis Biotherapeutics, Inc., unveiled new findings from the INTEGUMENT-OLE long-term open-label study of roflumilast cream 0.15% for adults and children with atopic dermatitis (AD). These results demonstrated continued improvements in AD signs and symptoms, including itch, over 56 weeks of treatment.

Among participants treated with once-daily roflumilast cream 0.15%, 66.2% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 56. Notably, for participants switching to proactive twice-weekly application after achieving disease clearance, the median duration of disease control was 281 days.

Dr Melinda Gooderham, medical director at SKiN Centre for Dermatology, emphasized the importance of long-term, steroid-free treatment options for AD. She highlighted the study's findings, suggesting that roflumilast cream may offer proactive flare-free disease control, improving treatment adherence and long-term disease management.

Dr Emma Guttman-Yassky, Waldman Professor of Dermatology and Immunology at Icahn School of Medicine, echoed this sentiment, emphasizing the shift from reactive flare management to long-term flare-free disease control. She noted the significance of proactive twice-weekly application in maintaining disease control.

Additional results showed that 66.2% of participants achieved EASI-75, and 56.9% experienced a significant reduction in itch at week 56. Importantly, roflumilast cream maintained a favorable safety and tolerability profile, with no new safety signals observed up to 56 weeks.

Dr Patrick Burnett, chief medical officer at Arcutis, highlighted roflumilast cream's unique formulation, emphasizing its non-greasy, emollient properties that absorb quickly without compromising skin barrier integrity. He expressed optimism about the lasting symptom relief and long-term efficacy offered by roflumilast cream, positioning it as a vital steroid-free topical option for patients with AD.

Reference

Arcutis announces new long-term data of roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children down to age six presented at revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. Press release. Arcutis. June 10, 2024. Accessed June 11, 2024.