New patient-reported outcomes data show once-daily, topical roflumilast provides significant reductions in itch. 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.

Topical roflumilast foam reduced both the severity and burden of itch and improved quality of life in two separate Phase 2 studies in scalp and body psoriasis and seborrheic dermatitis. Topical roflumilast foam showed a robust and rapid reduction of itch. Data were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress and reported by topical roflumilast developer Arcutis.

Mean reduction in itch scores in plaque psoriasis patients was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as two weeks. 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, compared to 12.7% for vehicle in DERMIS-1 and a 69.4% improvement from baseline DLQI score roflumilast cream, compared to 9.0% for vehicle in DERMIS-2.

Roflumilast foam showed similar reductions in itch among subjects with body and scalp psoriasis or seborrheic dermatitis.

In these studies, both roflumilast cream and roflumilast foam met their primary endpoints and were generally well-tolerated. 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%. 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.