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

• 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
  

SAN DIEGO, March 10, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (San Diego, CA, March 8 – 12) new data from its INTEGUMENT-PED pivotal Phase 3 study of investigational roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate atopic dermatitis. The study found that treatment with once-daily, steroid-free roflumilast cream 0.05% resulted in significant improvements in atopic dermatitis across multiple efficacy endpoints and all timepoints, including disease clearance as early as Week 1 and reduction in itch in the first 24 hours following application.

Results showed 25.4% of children treated with roflumilast cream 0.05% achieved the primary endpoint of IGA Success, defined as vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 10.7% treated with the vehicle (P<0.0001), with significant improvements also seen at Week 1 and Week 2. In the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P<0.0001).