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Roflumilast Cream Data Show Positive Outcomes for Plaque Psoriasis


Arcutis Biotherapeutics, Inc has released data from its DERMIS-1 and DERMIS-2 Phase 3 pivotal studies demonstrating that the topical significantly reduced the burden and severity of itch.

Arcutis Biotherapeutics, Inc announced new patient-reported data that demonstrated topical roflumilast application resulted in significant reductions of burden and severity of itch. The once daily application of roflumilast cream also improved the quality of life (QOL) of patients in the DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) phase 3 pivotal studies in chronic plaque psoriasis, according to the press release.1 These data were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress held from Sept 29 to Oct 2.

“Itch is the most frequently reported symptom associated with dermatologic conditions such as plaque psoriasis, scalp psoriasis, and seborrheic dermatitis, severely impacting patients’ quality of life. These robust and consistent data across multiple indications demonstrate that topical roflumilast significantly improved both the severity and burden of itch, that symptoms improved quickly and continued improving through the course of treatment,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in Chatham, New Jersey. 

He continued, “Meaningfully impacting symptoms that matter most to patients, such as itch, are at the core of Arcutis’ mission. Topical roflumilast continues to demonstrate strong efficacy with a safety and tolerability profile that, if approved, should enable chronic use and the ability to use across the body.”

Melinda J. Gooderham, MSc, MD, FRCPC, board certified dermatologist and medical director at the SKiN Center for Dermatology in Ontario, Canada, presented patient-reported outcome data from both DERMIS studies in patients with chronic plaque psoriasis treated with roflumilast cream at the conference. Her presentation was detailed in the release.

According to the release, it showed the mean reduction in Worst-Itch Numeric Rating Scale (WI-NRS) score was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as 2 weeks (mean change from baseline of -3.7 and -4.0 for roflumilast cream; -1.4 and -1.7 for vehicle; P<0.0001). 

Also, more than 2/3 of patients with a WI-NRS of 4 or greater at baseline achieved a reduction of 4 points or more with roflumilast cream compared to less than 1/3 of individuals using vehicle at week 8 (67.5% and 69.4% of patients using roflumilast cream compared to 26.8% and 35.6% using vehicle; P<0.0001). 

Overall QOL improved with the use of once-daily roflumilast cream as measured by the Dermatology Life Quality Index (DLQI). Study results showed improvement of 65.2% from baseline in the DLQI score for roflumilast cream versus 12.7% vehicle in DERMIS-1, and a 69.4% improvement from baseline DLQI score roflumilast cream versus 9.0% vehicle in DERMIS-2 (P<0.0001).1

Read more on topical roflumilast foam from our coverage of the 2 separate phase 2 studies that showed achieved reduction of itch in scalp and body psoriasis and seborrheic dermatitis.


1. New data highlighting itch reduction with topical roflumilast in multiple dermatologic conditions presented at European Academy of Dermatology and Venereology Congress. GlobeNewswire News Room. Published September 30, 2021. Accessed October 6, 2021. https://www.globenewswire.com/news-release/2021/09/30/2306185/0/en/New-Data-Highlighting-Itch-Reduction-with-Topical-Roflumilast-in-Multiple-Dermatologic-Conditions-Presented-at-European-Academy-of-Dermatology-and-Venereology-Congress.html 

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