Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials.

INTRODUCTION: Roflumilast cream 0.3% contains a selective, highly potent phosphodiesterase 4 inhibitor approved to treat plaque psoriasis. The Psoriasis Area and Severity Index (PASI)-High Discrimination (PASI-HD) is more precise than PASI when psoriasis involves < 10% of the area of an anatomic region. Clinical trials of roflumilast utilized PASI and its modified version, PASI-HD, to assess disease improvement. The objective of this analysis was to demonstrate the effect of topical roflumilast in patients with psoriasis and to compare PASI-HD with PASI. METHODS: DERMIS-1 and DERMIS-2 were phase III, 8-week, randomized, vehicle-controlled trials of once-daily roflumilast cream 0.3% in patients aged ≥ 2 years with psoriasis involving 2-20% body surface area. PASI and PASI-HD were clinical endpoint measures. RESULTS: At week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved ≥ 75% reduction in PASI (40.3% vs 6.5%; P < 0.0001) and PASI-HD (59.9% vs 17.9%; P < 0.0001). Evaluations using PASI-HD resulted in larger effect sizes compared with PASI at higher levels of response. CONCLUSIONS: Roflumilast-treated patients experienced greater improvements in disease severity than vehicle-treated patients. The PASI-HD can more accurately assess disease changes compared with PASI. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: DERMIS-1, NCT04211363; DERMIS-2, NCT04211389.