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

Document Type

Conference Proceeding

Publication Date


Publication Title

The Journal of clinical and aesthetic dermatology


Background: Roflumilast cream is a potent phosphodiesterase 4 inhibitor recently approved in the United States for treatment of plaque psoriasis with no limitations on duration of use. An open-label trial was conducted to evaluate long-term safety (52 weeks) of once-daily roflumilast cream (NCT03764475). This abstract presents data on durability of response as measured by the percentage of patients with an 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), and patients naïve to roflumilast were also enrolled (Cohort-2, n=102). All psoriasis lesions (except scalp) were treated, including face and intertriginous areas for up to 52 weeks. If affected, palms and soles were treated, but not evaluated towards any efficacy assessments. Median duration of response was determined using the Kaplan-Meier method.

Results: With cumulative treatment up to 64 weeks in Cohort-1 and 52 weeks in Cohort-2, long-term safety and tolerability were consistent with the 12-week, Phase 2b study. Overall, 73.5 percent of patients completed the study; 3.9 percent discontinued due to adverse events (AE) and 0.9 percent discontinued due to lack of efficacy. Treatment-related AEs were reported in 2.7 percent patients; none were deemed serious. Investigator tolerability assessments at each visit demonstrated 99 percent of patients rated “no evidence of irritation.” At Week 52, IGA Success (demonstrating Clear/Almost Clear plus 2-grade improvement from baseline) was achieved by 34.8 percent of patients in Cohort-1 and 39.5 percent in Cohort-2. Of patients in Cohort-2, 40 percent of patients achieved IGA success at Week 12. IGA Clear/Almost Clear was achieved by 46.8 percent of patients across both cohorts at Week 12 and consistent through Week 52 (44.8%). Similarly, a 60.5 percent mean PASI improvement and 60.1 percent 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, the median durability of IGA of Clear/ Almost Clear was 10 months (40.1 weeks). Among patients who achieved an IGA of Clear or Almost Clear, 50 percent maintained Clear or Almost Clear status for at least 10 months.

Conclusion: In this long-term safety study, roflumilast cream was well tolerated with a safety profile consistent with the parent Ph2b trial, and effectively maintained clear/almost clear skin with no tachyphylaxis observed.





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