Matthew Zirwas, MD: Roflumilast Foam for Seborrheic Dermatitis

Phase 2a trial data published in May showed once-daily PDE4 inhibitor roflumilast foam 0.3% was associated with a significant rate of patients achieved Investigators Global Assessment (IGA) disease severity and Worst Itch Numerical Rating Scale (WI-NRS) improvements for their seborrheic dermatitis at 8 weeks of treatment.¹

The findings precede the anticipated US Food and Drug Administration (FDA) decision date for Arcutis Biotherapeutics’ New Drug Application (NDA) to indicate roflumilast foam for seborrheic dermatitis by about 6 months. At least one investigator is convinced of the PDE4 inhibitor’s benefit for his patients.

In an interview with HCPLive during the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this week, roflumilast foam investigator Matthew Zirwas, MD, director of the clinical trials and dermatitis center at Dermatologists of Greater Columbus, praised the “stunning” impact of PDE4 inhibition—particularly as delivered by roflumilast—on his patients with seborrheic dermatitis.

“After I saw my first 3 patients back, I immediately called the company and said, ‘This is an absolute home run. This is like nothing I’ve ever seen from treating seborrheic dermatitis’,” Zirwas recalled.

Zirwas additionally referenced longer-term analysis of roflumilast foam for such patients, in which approximately half of all treated patients reported completely clear skin—“Not clear or almost clear, which we’re used to in dermatology,” he said. “Completely clear. That is insane.”

He further praised the drug’s diverse profile, describing its benefit to both non-steroidal and steroid options available for dermatitis—as evidenced by data showing “rapid and very high efficacy, combined with a really reassuring safety profile.”

“(That) makes it as close to a perfect drug as you can hope for in seborrheic dermatitis,” Zirwas said. “And once roflumilast gets through its last clinical trials, it’s going to be FDA-approved for psoriasis, atopic dermatitis and seborrheic dermatitis. Basically what that is going to mean is, if you have a rash on your face or your scalp, roflumilast is indicated. Those are the 3 things it could be.”

In further reviewing the available data for roflumilast foam 0.3% in seborrheic dermatitis, Zirwas highlighted the significance of the key secondary WI-NRS outcome and its relation to patient quality of life.

“Pruritus is such a huge issue for patients with scalp disease, and it’s something that clinicians often forget,” he said. “Seborrheic dermatitis is so itchy for these people, and it’s a really difficult thing socially.”

Zirwas is a sponsored speaker for AbbVie, Arcutis, Dermavant Sciences, Incyte, Lilly, Leo Pharma, Pfizer and Sanofi-Regeneron.

References

1. ^{Zirwas MJ, Draelos ZD, DuBois J, et al. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. 2023;159(6):613–620. doi:10.1001/jamadermatol.2023.0846}
2. ^{Bader K. FDA Accepts Roflumilast Foam NDA for the Treatment of Seborrheic Dermatitis. Dermatology Times. Published April 18, 2023. https://www.dermatologytimes.com/view/fda-accepts-roflumilast-foam-nda-for-the-treatment-of-seborrheic-dermatitis}