Efficacy and tolerability of roflumilast cream 0.15% for atopic dermatitis: Pooled subgroup analysis of patients with face/eyelid involvement from phase 3 INTEGUMENT-1/2 trials

Summary: Abstract Body: Roflumilast cream 0.15% (ROF) was effective and well tolerated in patients with atopic dermatitis (AD) aged ≥6 years in 2 phase 3 trials (INTEGUMENT-1/2; NCT04773587/NCT04773600). Outcomes in patients with face/eyelid involvement included Validated Investigator Global Assessment for AD (vIGA-AD) success (clear/almost clear plus ≥2-grade improvement), ≥75% improvement in Eczema Area and Severity Index for all body regions (EASI-75) and ≥75%/100% improvement for the head region (hEASI-75/100), and safety/tolerability. Of 1337 patients, 567 (42%) had face and 277 (21%) had eyelid involvement at baseline. At week 4, efficacy was greater for ROF versus vehicle (VEH) overall (vIGA-AD success, 31% vs 14%; EASI-75, 43% vs 21%; hEASI-75, 32% vs 22%; hEASI-100, 23% vs 15%) and in those with face (27% vs 10%; 36% vs 14%; 43% vs 23%; 29% vs 13%) and/or eyelid (30% vs 5%; 36% vs 8%; 40% vs 20%; 24% vs 9%) involvement. Improvements in EASI component scores were also greater for ROF versus VEH in all subgroups. Application site pain was reported for ≤2% of patients across treatments and subgroups. In the ROF group, no irritation/minimal erythema and no/mild sensation were reported by physicians and patients, respectively, for ≥97% and ≥81% at all timepoints across subgroups. Roflumilast cream 0.15% was well tolerated and improved outcomes in patients with AD involving the face or eyelids. Eric Simpson³, Alexandra Golant⁴, Lawrence Eichenfield⁵, Amy Paller¹, Jonathan I. Silverberg⁶, Melinda J. Gooderham⁷, Mercedes E. Gonzalez⁸, H. Chih-ho Hong⁹, David Krupa², Diane Hanna², Patrick Burnett², David H. Chu², David R. Berk² 1. Northwestern University Feinberg School of Medicine, Chicago, IL, United States. 2. Arcutis Biotherapeutics, Inc., Westlake Village, CA, United States. 3. Oregon Health & Science University, Portland, OR, United States. 4. Icahn School of Medicine at Mount Sinai, New York, NY, United States. 5. Rady Children’s Hospital, University of California School of Medicine, San Diego, San Diego, CA, United States. 6. The George Washington University School of Medicine and Health Sciences, Washington, DC, United States. 7. SKiN Centre for Dermatology, Queen’s University; Probity Medical Research, Kingston, ON, Canada. 8. Pediatric Skin Research, Coral Gables, FL, United States. 9. University of British Columbia, Vancouver, BC, Canada. Clinical Research: Interventional Research