Roflumilast Cream Remains Effective, Tolerable for Plaque Psoriasis Over 24-Week Open-Label Extension

Roflumilast cream may provide long-term skin clearance while remaining tolerable and safe in patients with chronic plaque psoriasis, according to open-label findings.

In new phase 3 interim data, a team of investigators from the US and Canada reported findings from an open-label extension showing the PDE-4 inhibitor agent from Acrutis was associated with a majority of pediatric and adult patients with psoriasis achieved disease clearance with very little treatment treatment-related discontinuation nor reports of irritation.

The ongoing study from DERMIS-OLE further supports the long-term use of the topical agent in reducing psoriasis burden.

Led by Kim A. Papp, MD, PhD, Acrutis scientific advisor and president of Probity Medical Research, investigators are leading a 24-week, open-label extension of the DERMIS trial. In pooled phase 3 DERMIS data presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting this year, roflumilast cream provided a nearly 7-fold improved rate of Investigator’s Global Assessment (IGA) benefit for patients with psoriasis versus placebo, as well as 48% rate of IGA clear or almost clear skin at week 8.

In the extension trial, Papp and colleagues are assessing a cohort of patients aged ≥2 years with psoriasis who had successfully completed a prior regimen of roflumilast cream, as well as a cohort of patients aged 2-17 years old who are naive to both the PDE-4 inhibitor and vehicle cream.

Interim data from the first cohort was made available in the published results. The population included 264 patients from the pair of 8-week DERMIS 1 and 2 trials. Through December 2020, 84.1% of the cohort completed the trial, 3.8% were ongoing and 12.1% had discontinued.

Investigators reported 1 patient discontinuation due to an adverse event. Another 69 (26.1%) patients experienced a treatment-emergent adverse event, of which most were deemed mild or moderate in severity. Just 1 adverse event was considered likely related to roflumilast cream; 3 were potentially related, and none were serious in severity.

Regarding tolerability, the team reported that approximately 96% of patients had no evidence of topical treatment-related irritation at each clinical visit. Investigators confirmed safety and tolerability data were consistent with previous phase 2, 52-week trial findings for roflumilast cream.

Half (50.0%) of treated patients achieved IGA clear or almost clear skin status at 24 weeks; another >75% of patients with baseline intertriginous-IGA of mild or worse (≥2)achieved intertriginous IGA success.

Additionally, nearly half (43.8%) of treated patients achieved 75% reduction on the Psoriasis Area and Severity Index (PASI 75) at week 24, and approximately two-thirds (62.4%) of patients with a baseline Worst Itch-Numeric Rating Scale score of ≥4 achieved a 4-point improvement.

“In this long-term safety study, roflumilast cream demonstrated favorable tolerability with no unexpected adverse events and effectively maintained clear/almost clear skin,” the team concluded.

The study, “Long-term Safety and Efficacy of Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Interim Results from a 24-week, Phase 3 Open-label Study,” was published in JDPA.