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Arcutis Biotherapeutics recently shared significant findings from a pair of clinical trials showing the efficacy of Zoryve (roflumilast) for the treatment of dermatologic conditions at the 2024 Winter Clinical Dermatology Conference in Hawaii. According to the results of one trial, patients administered Zoryve topical foam, 0.3%, for seborrheic dermatitis who previously showed an inadequate response to topical steroids were 3.5 times more likely to achieve IGA success than those administered other products. Additionally, a Phase III study of Zoryve 0.15% showed that 91.5% of patients treated for atopic dermatitis experienced a measurable improvement in Eczema Area and Severity Index (EASI) at week 4.1,2
According to the release, the treatment significantly increased the odds of improved quality of life at weeks 2, 4, and 8, compared with the control group as measured by the Dermatology Life Quality Index (DLQI) (odds ratio [OR] 6:97; 95% confidence interval [CI] 3.97, 12.24; p<0.001). An evaluation of DLQI in patients over the age of 17 years showed that 72.5% achieved minor differences early on in treatment, which eventually improved to 86.6% by the end of the study compared to 28.1% (p=0.001 and 53.6% p=0.001) in the control group.1
“Seborrheic dermatitis is a chronic, recurrent skin disease that can negatively impact the quality of life of affected individuals, including their self-esteem, emotional well-being, and ability to perform everyday tasks like work or social activities. This new analysis quantifies a meaningful improvement in both the signs and symptoms of seborrheic dermatitis as well as quality of life for individuals treated with Zoryve foam,” said trial investigator Matthew Zirwas, MD, founder, Bexley Dermatology Research Clinic, in the press release.1 “As a practitioner, this large subgroup analysis provides me with the confidence to include Zoryve foam as an important new treatment in my armamentarium to prescribe to my patients, including those who have failed topical steroids which are commonly prescribed for [seborrheic dermatitis].”
According to Arcutis, as the first topical drug approved for seborrheic dermatitis with a new mechanism of action for in two decades, Zoryve offers hope for filling an unmet need in this patient population.
“This subgroup analysis builds upon the existing evidence for Zoryve foam as an effective once-a-day treatment option for use in all skin and hair types to clear and control seborrheic dermatitis, including among those who previously experienced inadequate response or intolerance to topical steroids,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis, in the release.1
In another study presented at the Winter Clinical Dermatology Conference, data show 69.2% of patients with atopic dermatitis achieved a 50% decrease in eczema area and severity index after four weeks of using Zoryve as opposed to 44.4% of patients in the control group (p<0.0001). Additionally, the study reported a 75% reduction in EASI scores (EASI-75) in 44.5% of patients administered Zoryve compared to 21.2% of patients in the control group (p<0.0001). Finally, 22.4% of patients administered Zoryve achieved EASI-90 compared to 8.6% of control group patients (p<0.0001). Further, a 100% reduction (EASI-100) was observed in 9.8% of patients treated with Zoryve compared to 4.8% of vehicle-treated patients (p<0.002).2
“These data demonstrate the rapid and reliable efficacy of roflumilast cream in atopic dermatitis with the majority of individuals achieving measurable improvement in EASI in as little as one week,” stated Burnett in a release.2 “We are pleased to be able to share these individual response data with the wider dermatology community and develop a better understanding about the consistent clinical response to roflumilast cream for patients with atopic dermatitis.”2
When comparing safety and tolerability data with the control group, low rates of application site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs were comparable. Common AEs included headaches at 2.9%, nausea at 1.9%, application site pain at 1.5%, diarrhea at 1.5%, and vomiting at 1.5%.2
Last month, the FDA approved Zoryve for the treatment of seborrheic dermatitis in individuals nine years of age and older, making it the first topical drug approved for treating moderate to severe seborrheic dermatitis with a new mechanism of action in over two decades.
In late November, the FDA also accepted Arcutis’ Supplemental New Drug Application for Zoryve 0.15%, assigning it a Prescription Drug User Fee Act target action date of July 7, 2024.3
“With this filing acceptance, we are one step closer to potentially providing a new topical option for the millions of Americans living with atopic dermatitis. Given the prevalence of this disease in both children and adults, as well as the need for better long-term management, we believe once-daily, steroid-free roflumilast cream has the potential to become the new standard of care in atopic dermatitis,” said Frank Watanabe, president, CEO, Arcutis, per the announcement.3 “We look forward to working closely with the FDA during the review process as part of our ongoing efforts to develop topical roflumilast for the treatment of immune-mediated skin diseases.”
References
- ZORYVE® (Roflumilast) Topical Foam, 0.3% Clears Seborrheic Dermatitis in Individuals Who Previously Reported an Inadequate Response to Topical Steroids. Arcutis. January 14, 2024. Accessed January 15, 2024. https://www.arcutis.com/zoryve-roflumilast-topical-foam-0-3-clears-seborrheic-dermatitis-in-individuals-who-previously-reported-an-inadequate-response-to-topical-steroids/
- Majority of Individuals with Atopic Dermatitis Improved with Arcutis’ Roflumilast Cream 0.15% According to New Data from Phase 3 Program. Arcutis. January 14, 2024. Accessed January 15, 2024. https://www.arcutis.com/majority-of-individuals-with-atopic-dermatitis-improved-with-arcutis-roflumilast-cream-0-15-according-to-new-data-from-phase-3-program/
- FDA Accepts Arcutis’ Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6. Arcutis. November 29, 2023. Accessed January 15, 2024. https://www.arcutis.com/fda-accepts-arcutis-supplemental-new-drug-application-for-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-down-to-age-6/