Arcutis Biotherapeutics, Inc. announced new patient-reported outcome data that show topical roflumilast provides significant reductions in itch, a common and bothersome symptom of multiple dermatologic conditions. Once-daily roflumilast cream reduced both the severity and burden of itch, and improved quality of life, in the DERMIS-1 and DERMIS-2 Phase 3 pivotal studies in chronic plaque psoriasis. In addition, in two separate Phase 2 studies, topical roflumilast foam showed a robust and rapid reduction of itch in scalp and body psoriasis and seborrheic dermatitis. These data were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress (Sept 29 – Oct 2). Dr. Melinda J. Gooderham presented patient-reported outcome data from the DERMIS studies in patients with chronic plaque psoriasis treated with roflumilast cream that showed the mean reduction in Worst-Itch Numeric Rating Scale (WI-NRS) score was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as two weeks (mean change from baseline of -3.7 and -4.0 for roflumilast cream; -1.4 and -1.7 for vehicle; P<0.0001). In addition, more than two-thirds of patients with a WI-NRS of four or greater at baseline achieved a reduction of four-points or more with roflumilast cream compared to less than one-third of individuals using vehicle at week 8 (67.5% and 69.4% of patients using roflumilast cream compared to 26.8% and 35.6% using vehicle; P<0.0001). Overall quality of life was also improved with the use of once-daily roflumilast cream as measured by the Dermatology Life Quality Index (DLQI) with an improvement of 65.2% from baseline in the DLQI score for roflumilast cream vs 12.7% vehicle in DERMIS-1 and a 69.4% improvement from baseline DLQI score roflumilast cream vs 9.0% vehicle in DERMIS-2 (P<0.0001). In a separate poster presentation highlighting results from the Phase 2 randomized, double-blind, vehicle-controlled study of roflumilast foam in patients with plaque psoriasis on the scalp and body, 68.2% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 23.1% of patients using vehicle at week eight. These results are consistent with that observed specifically in the scalp with 71.0% of patients with a baseline Scalp Itch (SI)-NRS of four or greater at baseline achieving a four-point or greater improvement in SI-NRS as compared to 18.5% in the vehicle treated group. Likewise, data presented in a poster presentation from a Phase 2 study of patients with seborrheic dermatitis showed approximately 64.6% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 34.0% of patients using vehicle at week eight. In these studies, both roflumilast cream and roflumilast foam met their primary endpoints and were generally well-tolerated. Roflumilast cream 0.3% met its primary endpoint of Investigator Global Assessment Success rate at week 8 in 42.4% patients compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in the Phase 3 studies DERMIS-1 and DERMIS-2 respectively (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two). Roflumilast foam met its primary endpoint in the Phase 2 Scalp and Body study with a Scalp-Investigator Global Assessment success rate of 59.1% patients compared to a vehicle rate of 11.4% (P<0.0001). Of these, 34.3% of patients on roflumilast foam achieved a status of clear. Roflumilast foam met its primary endpoint in the Phase 2 seborrheic dermatitis study with 73.8% of roflumilast treated patients achieving IGA success at week 8 vs 40.9% of vehicle-treated patients (P<0.0001). Additionally, 35.5% of patients using roflumilast foam achieved an IGA status of clear at week 8 vs 15.2% of vehicle-treated patients.