SDPA Presents 20th Annual Fall Dermatology Conference–Abstracts and Posters
November 16-20, 2022, Miami, FL
2. Efficacy and Tolerability of Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis Involvement on the Face, Intertriginous, or Genital Areas: A Post-hoc Analysis of Phase 3 Trials
Laura K. Ferris on behalf of the DERMIS investigators and authors
University of Pittsburgh, Department of Dermatology, Pittsburgh, PA, USA
Introduction & Objectives: Patients with psoriasis have reduced quality of life compared to the general population. Those with psoriasis involving special areas, such as the face, intertriginous, and genital areas, may have a disproportionate negative impact on their quality of life. Chronic use of current topical treatment options are limited due to risk of local skin side effects. Roflumilast cream 0.3% is a selective and highly potent phosphodiesterase-4 inhibitor that was studied as a once-daily treatment for long-term management of chronic plaque psoriasis. In this abstract, we describe pooled results from two Phase 3, randomized, double-blind, vehicle-controlled, multi-center trials of once-daily roflumilast cream 0.3% in patients with psoriasis, presenting subgroup analyses of patients with involvement of special areas (SA: defined as the face, and/or intertriginous, and/or genital areas).
Materials & Methods: DERMIS-1 (n=439; NCT04211363) and DERMIS-2 (n=442; NCT04211389) were identical Phase 3 trials conducted in patients ≥2 years old with chronic plaque psoriasis involving 2-20% of body surface area (BSA). Patients were randomized 2:1 to receive once-daily roflumilast cream 0.3% or vehicle for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) success (defined as achievement of Clear or Almost Clear status plus ≥2-grade improvement from baseline) at Week 8. Post-hoc analyses were conducted on those patients with psoriasis involving SA. P-values for this analysis are nominal and are not corrected for multiple comparisons.
Results: Overall, significantly more roflumilast-treated patients than vehicle-treated patients achieved IGA success (39.9% vs. 6.5%; P<0.001) at Week 8. Among patients with psoriasis involving SA, the percentages of roflumilast-treated patients with IGA Success at Week 8 was higher than in vehicle-treated patients (any SA: 41.7% vs 2.7%, P<0.0001; intertriginous: 40.4% vs 1.8%, P<0.0001; face: 42.1% vs 1.3%, P<0.0001; genital: 39.3% vs 5.4%, P<0.0036). Differences favoring roflumilast cream 0.3% were observed for secondary endpoints, including percentage of patients with baseline Worst Itch-Numeric Rating Scale (WI-NRS) ≥4 achieving a 4-point reduction at Week 8 (any SA: 67.5% vs 26.8%; P<0.0001) and least square mean percent change from baseline in Psoriasis Symptoms Diary scores (any SA: -76.5% vs -25.0%; P<0.0001). In patients with involvement in SA, local tolerability was highly favorable as reported by patient and investigator assessment of irritation, burning, and stinging, with ≥97.6% of patients having no evidence of irritation at Week 8 on investigator-rated assessments. Overall incidence of treatment-emergent adverse events (TEAE), serious adverse events, and TEAEs leading to discontinuation were low with similar rates between roflumilast and vehicle across both studies.
Conclusions: Roflumilast cream 0.3% provided improvement across multiple efficacy endpoints versus vehicle cream while demonstrating favorable safety and tolerability in patients with chronic plaque psoriasis involving intertriginous, and/or face, and/or genital areas in two Phase 3 trials.