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

Keywords

roflumilast, adult, clinical trial, cohort analysis, conference abstract, controlled study, cream, drug efficacy, drug safety, drug therapy, drug tolerability, female, human, learning, major clinical study, male, open study, pharmacokinetics, phase 2 clinical trial, psoriasis vulgaris, scalp

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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