Significant Improvements in Itch and Itch-Related Sleep Loss with Roflumilast Cream

Results from Arcutis Biotherapeutics’ phase 2b trial show patients with chronic plaque psoriasis, treated with once daily roflumilast cream (0.3% and 0.15%) showed significantly greater improvements in itch by week 2 compared to those treated with vehicle.

The study was published in the American Journal of Clinical Dermatology. The patients were assessed by the Worst Itch Numeric Rating Scale (WI-NRS) and Psoriasis Symptom Diary (PSD). Roflumilast is a selective, highly potent phosphodiesterase-4 inhibitor (PDE4), with greater affinity for PDE4 and approximately 25- to >300-fold more potency than other FDA-approved PDE4 inhibitors. In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects aged 18 to 89 years were randomized to roflumilast 0.3%cream, roflumilast 0.15%cream or vehicle in a 1:1:1 ratio. The patients applied the roflumilast cream or vehicle once daily to all psoriasis lesions for 12 weeks.

Leading author, Linda Stein Gold, MD, director of Dermatology Clinical Research and Division Head of Dermatology at Henry Ford Healthy System in Detroit, Michigan said the data shows that roflumilast cream is an important non-steroidal treatment option; able to address the problem and provide rapid relief to those suffering from chronic, intense itch.

The study showed that improvement in WI-NRS was greater in patients treated with the cream in both arms, compared to vehicle at week 2(p ≤ 0.002), which was the first timepoint measured. They also showed greater improvements in severity of itch and bother of itch, measured by PSD, compared to vehicle at weeks 2 to 12 (p< 0.012 and p < 0.010, respectively). Both groups treated by the cream experienced improvements in itch-related sleep loss, as measured by NRS. Furthermore, roflumilast-treated patients experienced significantly greater improvements in itch-related sleep loss in weeks 6 through 12.

Chronic itch is the most bothersome symptom reported by patients with psoriasis. The US Food and Drug Administration approved roflumilast in July 2022 for the topical use in adults and adolescents with mild to severe plaque psoriasis.

Resources:

1. Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2022 Nov 12. doi: 10.1007/s40257-022-00739-3. Epub ahead of print. PMID: 36370336.