Roflumilast cream significantly improves patient burden and work productivity in patients with psoriasis

Document Type

Conference Proceeding

Publication Date

6-10-2022

Publication Title

Journal of Managed Care and Specialty Pharmacy

Abstract

BACKGROUND: Psoriasis can cause significant burden for patients, which can affect emotional health, sleep, and work performance. Roflumilast is a selective and highly potent topical phosphodiesterase-4 inhibitor in development for treatment of several dermatologic diseases, including psoriasis OBJECTIVE: To describe efficacy and safety of roflumilast cream 0.3% and 0.15% and effects on patient burden from a phase 2b randomized clinical trial. METHODS: Adults (aged ≥ 18 years) with chronic plaque psoriasis were randomized to once-daily roflumilast 0.3% (n = 109), roflumilast 0.15% (n = 113), or vehicle (n = 109) for 12 weeks (NCT03638258). The primary endpoint was the percentage of patients achieving Investigator Global Assessment (IGA) status of clear or almost clear at Week 6. Efficacy was also assessed by the Worst Itch Numeric Rating Scale (WI-NRS) and itch-related sleep loss NRS scores, Psoriasis Symptom Diary (PSD), and Work Productivity and Activity Impairment (WPAI; exploratory analysis). RESULTS: The primary endpoint was met by 28.0% of patients on roflumilast 0.3% (P < 0.001 vs vehicle), 22.8% on roflumilast 0.15% (P = 0.004 vs vehicle), and 8.3% on vehiclem (1). Significantly more patients with baseline WI-NRS ≥ 4 treated with roflumilast 0.3% achieved ≥ 4-point improvement on the WI-NRS and this difference occurred as early as Week 2 (P ≤ 0.034 vs vehicle); differences for roflumilast 0.15% were significant at weeks 6 and 12 (P ≤ 0.012 vs vehicle). Roflumilast-treated patients had greater improvement in itch-related sleep loss beginning at week 6 (P ≤ 0.022). Overall least squares (LS) mean change from baseline (CfB) in PSD total score (improvement) at week 12 was -42.0 for patients on roflumilast 0.3% (P < 0.001 vs vehicle), -44.2 for roflumilast 0.15% (P < 0.001 vs vehicle), and -20.9 with vehicle. Roflumilast also resulted in greater improvements on the individual PSD domains. In a post-hoc analysis, LS mean CfB in WPAI at week 12 favored roflumilast, including greater improvement in presenteeism (roflumilast 0.3%: -8.92 [nominal P = 0.013 vs vehicle]; roflumilast 0.15%: -7.63 [nominal P = 0.038 vs vehicle]; vehicle: -0.61) and general activity impairment outside of work (roflumilast 0.3%: -11.31 [nominal P = 0.011 vs vehicle]; roflumilast 0.15%: -8.75 [P = 0.103 vs vehicle]; vehicle: -4.40). Most treatment emergent adverse events were mild to moderate in severity and application site pain was uncommon and similar to vehicle. CONCLUSIONS: Once-daily roflumilast cream was well-tolerated with significant improvements in assessments of patient burden.

Volume

28

Issue

3-A

First Page

S62

Last Page

S63

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