Roflumilast Cream, a Once-daily, Potent Phosphodiesterase-4 Inhibitor, in Chronic Plaque Psoriasis Patients: Efficacy and Safety from DERMIS-1 and DERMIS-2 Phase 3 Trials

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Abstract

Introduction: Novel nonsteroidal topical therapies for psoriasis have not been approved in over 20 years. Recent data suggest roflumilast 0.3% cream, a potent phosphodiester ase-4 inhibitor, may represent a highly-effective, well-tolerated, nonsteroidal, once-daily treatment for long-term management of chronic plaque psoriasis, including the face and intertriginous areas. Methods, Results: Two identical Phase 3, randomized, double-blind, vehicle-controlled, multi-center trials (DERMIS-1 [n = 439; NCT04211363] and DERMIS-2 [n = 442; NCT04211389]) were conducted in patients ≥2 years old with chronic plaque psoriasis involving 2%-20% of body surface area. Patients were randomized 2:1 to receive roflumilast cream 0.3% or vehicle once-daily for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) success at Week 8. Significantly more roflumilast-treated patients reached IGA success (DERMIS-1: 42.4%; DERMIS-2: 37.5%) than vehicle-treated patients (DERMIS-1: 6.1%; DERMIS-2: 6.9%, P < 0.001 for both). In patients with intertriginous area involvement, significantly more roflumilast-treated patients reached intertriginous-IGA (I-IGA) success at week 8 than vehicle-treated (DERMIS-1: 71.2% vs. 13.8%, P < 0.0001; DERMIS-2: 68.1% vs 18.5%, P = 0.0004). A majority of these patients achieved I-IGA=0. Approximately 40% of patients achieved 75% reduction in Psoriasis Area Severity Index (PASI 75) by week 8 (DERMIS-1: 41.6% vs. 7.6%; DERMIS-2: 39.0% vs 5.3%, P < 0.0001). Patients with baseline Worst Itch-Numeric Rating Scale (WI-NRS) ≥4 achieved a 4-point reduction in WI-NRS at week 8 (DERMIS-1: 67.5% vs 26.8%; DERMIS-2: 69.4% vs 35.6%, P < 0.0001). Itch improvement was notable by 2 weeks, the earliest timepoint measured (DERMIS-2: P = 0.0026). Incidence of treatment-emergent adverse events (TEAE) were low and similar between roflumilast and vehicle groups. Pooled rates of TEAE leading to discontinuation (1.0% roflumilast vs 1.3% vehicle) and application site pain (1.0% roflumilast vs 0.3% vehicle) were low and comparable to vehicle. Conclusions: Roflumilast cream 0.3% demonstrated favorable safety and tolerability while delivering statistically superior efficacy vs vehicle across multiple endpoints in patients with chronic plaque psoriasis. Learning Objective To learn about the Phase 3 data demonstrating the efficacy, safety, and tolerability of once-daily, non-steroidal, roflumilast 0.3% cream, a potent PDE4 inhibitor, developed for the treatment of chronic plaque psoriasis To highlight the burdensome patient-reported outcome of itch in patients with chronic plaque psoriasis and the ability of once-daily roflumilast 0.3% cream to reduce itch. To learn about the efficacy and tolerability for intertriginous plaques demonstrating the ability to use roflumilast cream in these steroid-sensitive areas. Takeaway Message In two phase 3 studies, once-daily roflumilast cream 0.3% demonstrated favorable safety and tolerability while effectively improving chronic plaque psoriasis and burdensome signs and symptoms, such as itch.

Volume

25

Issue

1 SUPPL

First Page

78S

Last Page

79S

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