Long-term Safety and Efficacy of Roflumilast Cream 0.3% in Adult Patients with Chronic Plaque Psoriasis: Results from a 52-Week, Phase 2b Open-Label Study

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Abstract

Introduction: Roflumilast cream is a potent phosphodiesterase-4 inhibitor in development for plaque psoriasis. Favorable efficacy and safety of roflumilast cream in psoriasis from a phase 2b, 12-week study was recently published.1 Methods, Results: To evaluate long-term (52 weeks) safety of once-daily roflumilast cream, patients from that study could continue on open-label roflumilast cream 0.3% (Cohort-1, n = 230), and patients naïve to roflumilast were enrolled (Cohort-2, n = 102) (NCT03764475). All psoriasis lesions (except scalp) were treated, including face and intertriginous areas. 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% of patients completed the study; 3.9% discontinued due to adverse events (AE), and 0.9% due to lack of efficacy. Treatment-related AEs were reported in 2.7% patients; none were serious AEs. Investigator tolerability assessments at each visit demonstrated 99% of patients rated "no evidence of irritation." At Week 52, Investigator Global Assessment (IGA) of clear/almost clear and 2-grade improvement from baseline, was achieved by 34.8% of patients in Cohort-1 and 39.5% in Cohort-2. Of patients in Cohort-2, 40% of patients achieved IGA success at week 12. Of patients receiving roflumilast cream 0.3% in the parent trial who achieved IGA of clear/almost clear at 12 weeks and continued in the open-label trial, 66.7% achieved IGA of clear/almost clear at 64 weeks or their last visit. Conclusions: In this long-term safety study, roflumilast cream was well tolerated with no unexpected AEs, and effectively maintained clear/almost clear skin. 1Lebwohl MG, et al. NEJM 2020;383:229-239. Learning Objective To understand the safety and tolerability of once-daily roflumilast 0.3% cream over 52 to 64 weeks of treatment of psoriasis To understand the maintenance of efficacy of once-daily roflumilast 0.3% cream for the treatment of psoriasis up to 64 weeks To become aware of the low rate of patients discontinuing once-daily roflumilast 0.3% cream due to adverse events or lack of efficacy during this long-term study Takeaway Message In this long-term, open-label safety study, once-daily non-steroidal roflumilast cream was well-tolerated and effectively maintained clear/almost clear skin in patients with psoriasis.

Volume

25

Issue

1 SUPPL

First Page

75S

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