Roflumilast Foam, 0.3% Clears Seborrheic Dermatitis in Patients Who Reported Inadequate Response to Topical Steroids

Arcutis Biotherapeutics recently announced new data from its subgroup analysis of the STRATUM study which demonstrated adult and adolescent patients with seborrheic dermatitis who are contraindicated, intolerant, or unresponsive to topical steroids were 3.5 times more likely to achieve Investigator’s Global Assessment (IGA) Success with roflumilast foam, 0.3% (ZORYVE), compared to vehicle (78.8% roflumilast foam vs 48.3% vehicle; P<0.001). IGA success was defined as at least a 2-point reduction in IGA score from baseline and an IGA score of 0 (clear) or 1 (almost clear). Arcutis’ latest STRATUM data was presented at the 2024 Winter Clinical Hawaii Dermatology Conference in Honolulu, Hawaii, held January 12th through the 17th.¹

According to the new data, treatment with roflumilast foam significantly increased the odds of achieving a meaningful improvement in quality of life at weeks 2, 4, and 8 compared to vehicle and 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 aged 17 years and older, and 72.5% of patients achieved a minimally important difference in DLQI score as early as week 2, increasing to 86.6% by week 8 (compared to 28.1% P=0.001 and 53.6% P=0.001 for vehicle, respectively). Meaningful important difference was defined as at least a 4-point reduction in baseline DLQI score and achievement of a DLQI score of 0 or 1.

The US Food and Drug Administration (FDA) approved the historic roflumilast foam for the treatment of seborrheic dermatitis in patients aged 9 years and older in December 2023. Roflumilast foam is a once-daily steroid-free foam and the first FDA-approved drug for seborrheic dermatitis with a new mechanism of action in over 2 decades.²

“Seborrheic dermatitis is one of those issues that seems trivial and can be dismissed, but causes a great deal of distress and discomfort to patients. Making things more difficult, many of our existing treatments are formulated as creams, ointments, or oils. To have a new, cosmetically elegant foam formulation and a once-daily application is very exciting. Moreover, a non-steroidal medication like roflumilast seems ideal for this role, with a very favorable safety profile and the ability to use it on the face for longer periods of time safely,” said Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, in a recent interview with Dermatology Times.

According to the recent subgroup analysis data, the incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between roflumilast 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%). In total, the subgroup analysis included 189 adults and adolescents aged 9 years 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).

“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. 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,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in the news release.

References

1. ZORYVE (roflumilast) topical foam, 0.3% clears seborrheic dermatitis in individuals who previously reported an inadequate response to topical steroids. News release. Arcutis Biotherapeutics. January 14, 2024. Accessed January 14, 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/
2. FDA approves Arcutis’ ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. News release. Arcutis Biotherapeutics. December 15, 2023. Accessed January 14, 2024. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/