Roflumilast Cream Significantly Improves Chronic Plaque Psoriasis in Patients with Steroid-Sensitive Area Involvement

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Keywords

roflumilast, steroid, adult, clinical trial, conference abstract, controlled study, double blind procedure, drug efficacy, drug safety, drug therapy, drug tolerability, female, human, learning, major clinical study, male, neck, numeric rating scale, pharmacokinetics, phase 2 clinical trial, psoriasis vulgaris, randomized controlled trial

Abstract

Introduction: Roflumilast cream is a nonsteroidal, selective phosphodiesterase-4 inhibitor in development for plaque psoriasis (PsO). Methods, Results: A double-blind, phase 2b trial randomized adults with PsO to once daily roflumilast 0.3%, 0.15%, or vehicle for 12 weeks (NCT03638258).1 Efficacy was assessed using Investigator Global Assessment (IGA), Worst Itch Numeric Rating Scale (WI-NRS), and Psoriasis Symptom Diary (PSD). This posthoc analysis reports efficacy and safety in patients with steroid-sensitive area involvement (plaques on the face, neck, or in intertriginous areas). Of 331 patients, 160 had steroid-sensitive area involvement. The primary endpoint in the study, IGA status clear/almost clear at Week 6 was met by 27.2% patients with steroid sensitive areas (P = 0.007 vs vehicle), 22.3% (P = 0.026), and 6.3% on roflumilast 0.3%, roflumilast 0.15%, and vehicle, respectively; relative to 30.1% (P = 0.026), 24.1% (P = 0.098), and 12.0% patients without steroid-sensitive areas. Among patients with baseline WI-NRS score ≥4, 73.5%, 55.6%, and 32.6% of those with steroid-sensitive areas and 45.9%, 72.7%, and 23.7% of those without steroid-sensitive areas achieved a 4-point reduction with roflumilast 0.3%, 0.15%, or vehicle at Week 12. PSD improvement from baseline at Week 12 for patients with steroid-sensitive areas was -48.3 (P < 0.001), -43.1 (P = 0.012), and -24.9, and for patients without steroid-sensitive areas 35.7 (P = 0.003), 44.6 (P < 0.001), and -17.1. Most treatmentemergent adverse events were mild to moderate and there was no evidence of local irritation. Conclusions: Once-daily roflumilast cream was well tolerated with significant improvements in investigator and patientassessed PsO outcomes in patients with steroid-sensitive area involvement on the face, neck, or intertriginous areas. Reference 1. Lebwohl MG, et al. N Engl J Med. 2020;383(3):229-239. Learning Objective To understand the challenges in treating psoriasis in patients with steroid-sensitive area involvement (plaques on the face, neck, or in intertriginous areas). To understand the safety and efficacy of once-daily, non-steroidal roflumilast cream for treating psoriasis in patients with steroid-sensitive area involvement To understand the tolerability of once-daily roflumilast cream for treating psoriasis in patients with steroid-sensitive area involvement Takeaway Message Once-daily roflumilast cream provided significant improvements in psoriasis in patients with steroid-sensitive area involvement and was well-tolerated.

Volume

25

Issue

1 SUPPL

First Page

77S

Last Page

78S

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