Study Finds Long-Term Safety and Efficacy for Roflumilast Cream for Chronic Plaque Psoriasis

A poster presentation at the 2023 Winter Clinical Dermatology Conference in Kohala Coast, Hawaii shared the results from a long-term study of roflumilast cream 0.3% (Zoryve) for chronic plaque psoriasis¹. In summer 2022, the US Food and Drug Administration (FDA) approved the treatment for adolescents and adults. The phase 2 long-term safety study results found the once-daily, nonsteroidal topical phosphodiesterase 4 (PDE4) inhibitor was well-tolerated with a safety profile consistent with the previous 2b trial.

This 52-week phase 2 safety trial was conducted at 30 testing centers in the US and Canada and was supported by Arcutis Biotherapeutics, Inc. In the study, adults with chronic plaque psoriasis (N=332) were split into 2 cohorts. Cohort 1 included patients (N=230) who had completed the last 2b phase trial through week 12. During the last stretch of the study, patients were permitted to stop treatment for cleared lesions. Cohort 2 (N=102) included eligible patients who were newly enrolled to the study. To qualify for the study, patients had to be at least 18 years old, diagnosed with at least a mild case of plaque psoriasis for a minimum of 6 months, and have 2-25% body surface area (BSA) affected by plaque psoriasis. Patient demographics and clinical characteristics at baseline were similar across both cohorts.

Percentages of patients achieving Investigator Global Assessment (IGA) Success and an IGA of clear or almost clear were consistent over time. Among patients with intertriginous area involvement, roflumilast cream provided consistent improvement. The median durability of IGA clear/almost clear for the 185 patients who achieved such during the open label trial was 10 months (40.1 weeks).

Safety was also consistent with the parent trial. More than 90% of adverse events (AEs) were rated mild or moderate in severity, and 97% of AEs were unrelated or unlikely to be related to plaque psoriasis, as determined by study clinicians. More than 97% of patients had no evidence of irritation to the cream during each of their visits. In addition, the study authors found no evidence of tachyphylaxis.

Reference

1. Lebwohl M, Gold LS, Gooderham MJ et al. Durability of Efficacy and Safety of Roflumilast Cream 0.3% in Adults With Chronic Plaque Psoriasis From a 52-Week, Phase 2 Open-Label Safety Trial. Poster presented at: 2023 Winter Clinical Dermatology Conference - Hawaii (WCH23); January 13-18, 2023. Kohala Coast, HI.