- Data show roflumilast produced robust efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of IGA success at eight weeks
- Roflumilast also demonstrated statistically significant improvements over vehicle in the key secondary endpoints of I-IGA success, PASI-75, and reduction in itch as measured by WI-NRS
- Improvement in itch occurred as early as two weeks and improved consistently through week eight
- Roflumilast safety and tolerability were similar to vehicle
Both Phase 3 trials achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at week eight, with significantly more patients treated with roflumilast cream 0.3% reaching IGA success compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs. 6.1%; DERMIS-2: 37.5% vs. 6.9%, respectively, P<0.001 for both). IGA success is defined as clear or almost clear with at least a 2-grade improvement from baseline.
“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,” said
Roflumilast also demonstrated statistically significant improvements over vehicle in key secondary endpoints, including the treatment of psoriasis presenting in intertriginous areas (i.e., where two skin areas may touch or rub together), as measured by intertriginous-IGA (I-IGA) success (clear or almost clear with at least a 2-grade improvement from baseline). When plaque psoriasis presents in intertriginous areas, it can be particularly challenging to treat, with physicians often needing to prescribe a regimen of multiple medications for a single patient. 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 (DERMIS-1: 71.2% vs. 13.8%, P<0.0001; DERMIS-2: 68.1% vs 18.5%, P=0.0004), with the vast majority of these patients achieving I-IGA=0 (clear).
“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,” said
Other key Phase 3 findings include:
- 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 (DERMIS-1: 41.6% vs 7.6%; DERMIS-2: 39.0% vs 5.3%, P<0.0001).
- 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 (DERMIS-1: 67.5% vs 26.8%; DERMIS-2: 69.4% vs 35.6%, P<0.0001). Itch improvement was notable by two weeks, the earliest timepoint measured (DERMIS-2: P=0.0026), with consistent improvements achieved through week eight.
- Roflumilast safety and tolerability were similar to vehicle, including pooled rates of treatment-related treatment-emergent adverse events (AEs) (3.9% roflumilast vs. 3.6% vehicle), any AE leading to discontinuation (1.0% roflumilast vs 1.3% vehicle) and application site pain (1.0% roflumilast vs 0.3% vehicle). There were no treatment-related serious AEs, and local tolerability was highly favorable for roflumilast as reported by patient and investigator assessment of irritation, burning, and stinging.
The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque Psorias
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Disclosure:
About Plaque Psoriasis
Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in
About Topical Roflumilast Cream
Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the
About Arcutis
Forward-Looking Statements
This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with
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