Arcutis presents Phase 2 long-term data in adults with chronic plaque psoriasis

Arcutis Biotherapeutics announced new safety and efficacy durability data from its open label Phase 2 long-term safety study evaluating once-daily roflumilast cream in adults with chronic plaque psoriasis. Roflumilast cream 0.3% is a once-daily steroid free topical phosphodiesterase-4 inhibitor approved by the US Food and Drug Administration in July 2022. The study, which was presented at the Winter Clinical dermatology meeting, showed that during the trial, 57.1% of roflumilast cream-treated patients achieved an Investigator Global Assessment score of clear or almost clear at any time in study, and these participants had a median duration of IGA of clear or almost clear of more than 10 months. Additionally, the percentages of participants achieving IGA success and an IGA of clear or almost clear were maintained over the course of the 52 weeks, and were consistent with the DERMIS trials. Roflumilast cream was safe and very well tolerated, with the majority of adverse events mild-to-moderate in severity. In the multicenter, open-label, single-arm, long-term Phase 2 safety trial, two cohorts of participants were enrolled. Cohort-1 participants were those who completed the Phase 2b trial through Week 12, whereas Cohort-2 participants were newly enrolled. Safety data showed rates of discontinuations due to AEs were low, and greater than or equal to97% of patients had no evidence of irritation per investigator local tolerability assessment at each visit.