Arcutis Biotherapeutics Inc. (ARQT) Announces Publication of 0.3% Roflumilast Cream Results from the DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis
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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of the American Medical Association (JAMA) has published positive results from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) evaluating roflumilast cream 0.3% as a once-daily topical treatment for chronic plaque psoriasis. The study, which was published in the September 20 issue of JAMA, found that treatment with roflumilast cream resulted in significant improvements on several efficacy parameters, including plaque clearance and itchiness at eight weeks in adults and adolescents with plaque psoriasis by relative to the vehicle. ZORYVE was approved for topical use in plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.
“These data highlight the robust efficacy of ZORYVE as a new nonsteroidal treatment option for people with plaque psoriasis. Both studies met the primary endpoint of IGA success and demonstrated rapid plaque clearance and reduced itchiness,” said Patrick Burnett, MD, Ph.D., Arcutis Chief Medical Officer . “Coupled with favorable safety and tolerability data from ZORYVE, these results confirm that ZORYVE can offer patients a single topical treatment for use on all areas affected by psoriasis, including hard-to-treat areas such as elbows and knees and intertriginous areas. We are delighted that such a prestigious journal has published the results of our pivotal phase 3 trials.”
“The itching that can occur in patients with chronic plaque psoriasis has negative effects on patients’ quality of life,” said Mark Lebwohl MD, FAAD, Principal Investigator and Dean of Clinical Therapeutics and Chairman Emeritus of the Kimberly Department. and Eric J. Waldman. dermatology at the Icahn School of Medicine at Mount Sinai; and a paid consultant and investigator for Arcutis. “The data from these studies demonstrated that ZORYVE was effective in providing rapid and significant reduction in itchiness as early as the second week, and significantly improved itch-related sleep loss and scores on the Dermatologic Quality of Life Index (at week 6. In addition, ZORYVE rapidly cleared plaque in patients with mild, moderate, and severe disease, as well as in intertriginous areas.
The “Essays of POF4 muting with Rof Lumilast for the Mmanagement of plaque psoriasisIS“One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3, randomized, parallel, double-blind, vehicle-controlled, multinational, multicenter studies in which 0.3% roflumilast cream or corresponding vehicle cream were applied. once daily for eight weeks in subjects 2 years of age and older with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% of body surface area. DERMIS-1 enrolled 439 subjects and DERMIS-2 enrolled 442 subjects.
In both studies, significantly more patients treated with roflumilast cream achieved IGA success at week eight compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs. 1%; DERMIS-2: 37.5% vs. 6.9%, respectively, P
Other Phase 3 key results include:
- Roflumilast has been shown to be very effective for psoriasis in the intertriginous areas (i.e. where two areas of skin can touch or rub together), with significantly more patients treated with roflumilast achieving IGA success (I-IGA) at week eight than vehicle-treated patients (DERMIS-1: 71.2% vs. 13.8%; DERMIS-2: 68.1% vs. 18.5%, P
- Roflumilast demonstrated improvement in psoriasis compared to vehicle at all time points as measured by the Psoriasis Area Severity Index (PASI). In both trials, approximately 40% of patients achieved a 75% reduction in PASI (PASI-75) scores at week eight (DERMIS-1: 41.6% vs. 7.6%; DERMIS-2: 39, 0% versus 5.3%, P
- Roflumilast also significantly improved patient-reported signs and symptoms, as measured by significantly greater improvements in the Psoriasis Symptom Diary.
- The safety and tolerability of roflumilast was similar to vehicle, including pooled rates of treatment-related adverse events (AEs) (4.0% roflumilast vs. 3.6% vehicle), with any AE resulting in discontinuation (1.0% roflumilast vs 1.3% vehicle) and application site pain (1.0% roflumilast vs 0.3% vehicle). There were no serious treatment-related AEs and local tolerance was very favorable for roflumilast as reported by patients and the investigator who assessed irritation, burning and stinging.
To learn more about the data, see full article.
