Takeaways:
- Roflumilast foam 0.3% (ZORYVE) demonstrated significant efficacy in adolescent and adult seborrheic dermatitis patients who had an inadequate response, contraindication, or intolerance to steroids.
- The subgroup analysis revealed a 3.5 times higher likelihood of achieving Investigator Global Assessment (IGA) Success with roflumilast foam compared to the vehicle.
- FDA approved in December 2023, roflumilast foam is indicated for treating seborrheic dermatitis in patients aged 9 years and older.
- The STRATUM study (NCT04973228) included 189 individuals with moderate-to-severe seborrheic dermatitis, showing that roflumilast foam significantly improved quality of life, measured by the Dermatology Life Quality Index (DLQI).
- Roflumilast foam's positive impact on both signs and symptoms of seborrheic dermatitis, especially in patients who failed topical steroids, positions it as a valuable treatment option.
New data from a subgroup analysis of roflumilast foam 0.3% (ZORYVE; Arcutis Biotherapeutics) revealed adolescent and adult seborrheic dermatitis patients with an inadequate response, contraindication, or intolerance to steroids were 3.5 times more likely to achieve Investigator Global Assessment (IGA) Success with the steroid-free, once-daily topical foam compared to vehicle (78.8% vs 48.3% [P < 0.001).1
Data was presented at the 2024 Winter Clinical Dermatology Conference in Honolulu, Hawaii.1
Roflumilast 0.3% was approved by the FDA in December 2023 and is indicated to treat seborrheic dermatitis in patients aged 9 years and older. Arcutis intends to make the topical foam available via “key wholesaler and dermatology pharmacy channels” by the end of January 2024.2
The subgroup analysis of the study of roflumilast foam applied topically for the reduction of seborrheic dermatitis (STRATUM; NCT04973228) included 189 adolescents and adults (41.4% of study population) with moderate-to-severe seborrheic dermatitis who reported inadequate response, intolerance, or a contraindication to steroids.1
At weeks 2, 4, and 8, roflumilast foam increased the odds of achieving a meaningful improvement in quality of life compared to vehicle (odds ratio 6:97; 95% CI 3.97, 12.24 [P < 0.001]), measured using the Dermatology Life Quality Index (DLQI).1
Measured in patients 17 years and older, 72.5% of individuals achieved a minimally important difference in DLQI score as early as 2 weeks and increased to 86.6% at the end of the study (week 8). These results compared to 28.1% (P = 0.001) and 53.6% (P = 0.001), respectfully, with vehicle.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,” said Matthew Zirwas, MD, trial investigator, founder, Bexley Dermatology Research Clinic, in a statement.1
“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 [roflumilast] foam. As a practitioner, this large subgroup analysis provides me with the confidence to include [roflumilast] 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 s[eborrheic dermatitis],” added Zirwas.1
The most common adverse reactions (≥1%) were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). There were no treatment-related serious adverse events, and the incidence of treatment emergent adverse events was low and similar between active and vehicle treatments.1
References:
- ZORYVE (roflumilast) topical foam, 0.3% clears seborrheic dermatitis in individuals who previously reported an inadequate response to topical steroids. Arcutis Biotherapeutics. Press release. 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/
- Fitch, J. FDA approves roflumilast foam 0.3% to treat seborrheic dermatitis in patients 9 years and up. Contemporary Pediatrics. December 15, 2023. Accessed January 15, 2024. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-foam-0-3-to-treat-seborrheic-dermatitis-in-patients-9-years-and-up
