New data from the DERMIS-1 and DERMIS-2 pivotal phase 3 studies evaluating roflumilast cream (ARQ-151) show that the investigational once daily, topical PDE4 inhibitor for psoriasis achieved the primary efficacy endpoint of IGA success at week eight for chronic plaque psoriasis. Data are being presented at the European Association of Dermatology and Venereology (EADV) Spring Symposium. 

At week 8, significantly more patients treated with roflumilast cream 0.3% had an IGA of clear or almost clear, with at least a 2-grade improvement from baseline, compared to vehicle-treated controls. Roflumilast is in development by Arcutis Biotherapeutics.

“While nearly 90 percent of people with plaque psoriasis rely upon topical therapies, unfortunately, existing options often have significant shortcomings that force these patients and their dermatologists to make trade-offs between efficacy, safety, and tolerability,” says Patrick Burnett, MD, PhD, FAAD, Arcutis’ Chief Medical Officer. “We are excited to share these Phase 3 trial findings, which we believe reinforce roflumilast cream as a potential topical treatment that is uniquely suited to address this unmet need and help those who have been struggling to treat their condition.”

Roflumilast also demonstrated statistically significant improvements over vehicle in key secondary endpoints, including the treatment of psoriasis presenting in intertriginous areas, as measured by intertriginous-IGA (I-IGA) success. In the Phase 3 trials, roflumilast was highly effective for intertriginous plaques, with significantly more roflumilast-treated patients reaching I-IGA success at week eight than vehicle-treated patients.

“Historically, there has been a significant lack of innovation in the development of topical treatments for plaque psoriasis, with no novel nonsteroidal topical therapies approved in more than two decades,” says Mark Lebwohl, MD, Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and participant in the trial. “This needs to be remedied, as those who suffer from the burden of chronic plaque psoriasis and their doctors need and deserve better options. These data, which demonstrate a robust efficacy and safety profile for roflumilast cream, represent a hopeful sign for the possibility of advancing the care of this condition.”

Roflumilast was statistically superior to vehicle for improvement of psoriasis at all timepoints as measured by the Psoriasis Area Severity Index (PASI). Across both trials, approximately 40% of patients achieved a 75% reduction in PASI scores (PASI-75) by week eight.

Patients with clinically significant itch, as measured by a baseline Worst Itch-Numeric Rating Scale (WI-NRS) ≥4, achieved a 4-point reduction in WI-NRS at week eight. Itch improvement was notable by two weeks, the earliest timepoint measured, with consistent improvements achieved through week eight.