Arcutis Biotherapeutics announces publication of data on roflumilast cream

Arcutis Biotherapeutics announced the publication of patient-reported outcome itch data from its Phase 2b study evaluating once-daily roflumilast cream in adults with chronic plaque psoriasis. The study, which was published online in the American Journal of Clinical Dermatology shows that those treated with roflumilast cream 0.3% experienced significantly greater improvements in WI-NRS as well as severity and bother of itch by the earliest timepoint measured, Week 2, and itch-related sleep loss from Weeks 6 through 12, than those treated with vehicle. Roflumilast is a selective, highly potent phosphodiesterase-4 inhibitor, with greater affinity for PDE4 and approximately 25- to greater than300-fold more potency than other FDA-approved PDE4 inhibitors. In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects ranging from ages 18 to 89 years were randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle in a 1:1:1 ratio. Roflumilast cream or vehicle was applied once daily to all psoriasis lesions for 12 weeks. Improvement in WI-NRS was greater in individuals treated with roflumilast cream in both arms compared to vehicle beginning at Week 2, the first timepoint measured. Among a subgroup of participants with a baseline WI-NRS greater than6, significantly more of those treated with roflumilast 0.3% achieved an improvement of greater than or equal to4 compared to vehicle by Week 2. Those treated with roflumilast cream in both arms reported greater improvements in severity of itch and bother of itch, as measured by PSD, compared to vehicle at Weeks 2 to 12. Additionally, both roflumilast-treated groups experienced similar improvements in itch-related sleep loss as measured by itch-related sleep loss NRS, which was greater than the vehicle-treated group beginning at Week 6. Improvement on the Dermatology Life Quality Index Score was observed at Week 6 for those treated with roflumilast cream 0.3% compared to those treated with vehicle and for both roflumilast-treated groups at Week 12.