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

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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