Arcutis Data From INTEGUMENT-PED Phase 3 Trial in Atopic Dermatitis in Children

 

• Investigational roflumilast cream 0.05% met the primary endpoint and all secondary endpoints, showing significant improvement across multiple efficacy endpoints as early as Week 1
• 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint
• New data highlight rapid and significant reduction in itch as early as 24 hours following first application of roflumilast cream 0.05% based on daily Worst Itch Numeric Scale (WI-NRS)
• New data show 35.4% of children treated with roflumilast cream 0.05% achieved a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ at Week 4, with significant improvements seen as early as Week 1
• Results for roflumilast cream 0.05%, show consistent efficacy and favorable safety and tolerability profile from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials

https://www.globenewswire.com/news-release/2024/03/10/2843436/0/en/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-.html