Durability of Efficacy and Safety of Roflumilast Cream 0.3% in Adults with Chronic Plaque Psoriasis from a 52-Week, Phase 2 Open-Label Safety Trial
Author(s)
Lebwohl M1, Stein Gold L2, Gooderham M3, Papp KA4, Ferris LK5, Adam DN6, Hong HCH7, Kircik LH8, Zirwas M9, Burnett P10, Higham R10, Krupa D10, Berk DR10
1Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2Henry Ford Medical Center, Detroit, MI, USA, 3SKiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada, 4Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada, 5University of Pittsburgh, Pittsburgh, PA, USA, 6CCA Medical Research, Probity Medical Research and Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada, 7Probity Medical Research and University of British Columbia, Department of Dermatology and Skin Science, Surrey, BC, Canada, 8Skin Sciences, PLLC, Louisville, KY, USA, 9Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH, USA, 10Arcutis Biotherapeutics, Inc, Westlake Village, CA, USA
Presentation Documents
OBJECTIVES: Roflumilast cream is a potent phosphodiesterase 4 inhibitor recently approved in the United States for treatment of plaque psoriasis. An open-label trial was conducted to evaluate long-term safety (52 weeks) of once-daily roflumilast cream (NCT03764475). Durability of response was measured using Investigator Global Assessment (IGA) score of Clear or Almost Clear, percentage improvement in Psoriasis Area Severity Index (PASI) score, and reduction in body surface area (BSA) affected.
METHODS: Patients who completed a parent, phase 2b, 12-week randomized controlled trial could continue on open-label roflumilast cream 0.3% (Cohort-1, n=230); patients naïve to roflumilast were also enrolled (Cohort-2, n=102). All psoriasis lesions (except scalp) were treated for up to 52 weeks.
RESULTS: Overall, 73.5% of patients completed the study; 3.9% discontinued due to adverse events (AE) and 0.9% discontinued due to lack of efficacy. Treatment-related AEs were reported in 2.7% patients; none were deemed serious. Investigator tolerability assessments at each visit demonstrated 99% of patients rated “no evidence of irritation.” At Week 52, IGA Success (Clear/Almost Clear plus 2-grade improvement from baseline) was achieved by 34.8% of Cohort-1 and 39.5% of Cohort-2 patients. IGA Clear/Almost Clear was achieved by 46.8% of patients across both cohorts at week 12 and consistent through week 52 (44.8%). A 60.5% mean PASI improvement and 60.1% mean BSA improvement from baseline were observed at week 12 and consistent through week 52 (59.4% and 63.3%, respectively). Of the 185 patients who achieved IGA Clear/Almost Clear during the open-label trial, median durability of IGA of Clear/Almost Clear was 10 months (40.1 weeks); 50% maintained Clear/Almost Clear status for ≥10 months.
CONCLUSIONS:
In this long-term safety study, roflumilast cream was well tolerated with a safety profile consistent with the Phase 2b trial, and effectively maintained clear/almost clear skin with no tachyphylaxis observed. Sponsored by Arcutis Biotherapeutics, Inc.Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
CO45
Topic
Clinical Outcomes
Topic Subcategory
Clinician Reported Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas