Zoryve (roflumilast) topical foam, 0.3% clears seborrheic dermatitis in individuals who previously reported an inadequate response to topical steroids
Arcutis Biotherapeutics, Inc. announced a new subgroup analysis highlighting that adults and adolescents with seborrheic dermatitis who are contraindicated, intolerant, or unresponsive to topical steroids were 3.5 times more likely to achieve IGA Success with Zoryve(roflumilast) topical foam, 0.3%, compared to vehicle (78.8% Zoryve foam; 48.3% vehicle; p<0.001)
Zoryve foam is a once-daily steroid-free topical for use in all skin and hair types that effectively clears and controls seborrheic dermatitis. Data were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu.
Treatment with Zoryve foam significantly increased the odds of achieving a meaningful improvement in quality of life at Weeks 2, 4, and 8, compared to vehicle 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). dlqi was measured in patients 17 years of age and older. 72.5% of individuals achieved a minimally important difference in dlqi score as early as 2 weeks, increasing to 86.6% at the end of the study, week 8 (compared to 28.1% p="0.001" and 53.6% p="0.001" for vehicle, respectively).
“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 Matthew Zirwas, MD, founder of the Bexley Dermatology Research Clinic and an investigator in the trial. “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 seb derm.”
“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 of Arcutis. “As the first topical drug approved with a new mechanism of action for this condition in 20 years, Zoryve foam represents an important advancement in treatment and addresses a truly significant need in this population.”
Zoryve foam was well-tolerated with a favorable safety and tolerability profile. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). Overall, the most common adverse reactions (?1%) included nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) evaluated Zoryve foam vs vehicle once daily for 8 weeks. The subgroup analysis included 189 adults and adolescents 9 years of age and older with moderate-to-severe seborrheic dermatitis who reported an inadequate response, intolerance, or contraindication to steroids prior to enrollment in the STRATUM study (41.4% of the total study population).
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