Efficacy and safety of once-daily roflumilast foam 0.3% for psoriasis of the scalp and body involving knees/elbows: Subgroup results from the phase 3 arrector trial

Summary: Abstract Body: Thick stratum corneum on knees/elbows can complicate topical psoriasis treatment. Roflumilast foam 0.3% (ROF) is approved for seborrheic dermatitis and is being investigated for psoriasis of the scalp and body. In the phase 3 ARRECTOR/NCT05028582 trial, patients aged ≥12 years with psoriasis of the scalp and body (maximum body surface area ≤25%, at least moderate Scalp-Investigator Global Assessment [IGA], and at least mild Body-IGA [B-IGA]) were randomized to once-daily ROF or vehicle(VEH) for 8 weeks. Endpoints included B-IGA success (clear/almost clear plus ≥2-grade improvement), ≥75% improvement in Psoriasis Area and Severity Index (PASI-75), and safety. Outcomes in patients with baseline knee/elbow involvement are described; all P values are nominal. At baseline, 71% (199/281) of the ROF group and 72% (109/151) of the VEH group had knee/elbow involvement. After 8 weeks, B-IGA success was significantly higher with ROF vs VEH (43% vs 18%; P<0.001). Significantly higher proportions (each P<0.001) of those with knee involvement achieved regional lower-limb PASI-75/100 with ROF(39%/31%) vs VEH(10%/8%); for elbow involvement, significantly higher proportions achieved upper-limb PASI-75/100 (42%/30% vs 19%/13%). Improvements with ROF vs VEH were also observed for individual PASI components. Safety in patients with knee/elbow involvement was consistent with the overall population. Once-daily ROF provided significant improvement across multiple efficacy measures in patients with psoriasis of the scalp and body involving knees/elbows. Melinda J. Gooderham², Tina Bhutani³, Melodie Young⁴, April Armstrong⁵, Mark Lebwohl⁶, Michael Bukhalo⁷, Laura K. Ferris⁸, Melissa S. Seal¹, Saori Kato¹, David Krupa¹, David H. Chu¹ 1. Arcutis Biotherapeutics, Inc., Westlake Village, CA, United States. 2. SKiN Centre for Dermatology, Probity Medical Research, Queen’s University, Kingston, ON, Canada. 3. Synergy Dermatology, San Francisco, CA, United States. 4. Mindful Dermatology, Modern Research Associates, Dallas, TX, United States. 5. University of California Los Angeles, Los Angeles, CA, United States. 6. Icahn School of Medicine at Mount Sinai, New York, NY, United States. 7. Rosalind Franklin University of Medicine and Science Chicago Medical School, Arlington Dermatology, Rolling Meadows, IL, United States. 8. University of North Carolina, Chapel Hill, NC, United States. Clinical Research: Interventional Research