Roflumilast Foam Effective for Seborrheic Dermatitis Patients Inadequately Responding to Steroids

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In this subgroup analysis data shown at Winter Clinical, findings indicated IGA success with topical roflumilast foam among seborrheic dermatitis patients.

Matthew Zirwas, MD

Credit: Dermatologists of Central States

Matthew Zirwas, MD

Credit: Dermatologists of Central States

Seborrheic dermatitis patients showing an inadequate steroid response, as well as intolerance or contraindications, are 3.5 times more likely to see success in their Investigator’s Global Assessment (IGA) score after using topical roflumilast (Zorvye) foam, 0.3%, according to new findings.1

These new data on the effects of the steroid-free, once-per-day topical were announced by Arcutis Biotherapeutics and presented at the 2024 Winter Clinical Dermatology Conference in Hawaii. The findings were the results of a subgroup analysis from the STRATUM trial.

“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,” Matthew Zirwas, MD, Bexley Dermatology Research Clinic founder and STRATUM investigator, said in a statement. “As a practitioner, this large subgroup analysis provides me with the confidence to include (roflumilast) foam as an important new treatment…including those who have failed topical steroids which are commonly prescribed for seb derm.”

Both adolescent and adult patients with seborrheic dermatitis who had been contraindicated, intolerant, or not responsive to topical steroids were shown by the investigators to be 3.5 times more likely to have IGA Success versus vehicle (78.8% for the treatment arm; 48.3% for the vehicle arm; P<0.001). This subgroup analysis added to the overall findings from the trial on roflumilast.

The trial had showed that the treatment substantially elevated likelihood of substantial enhancement in quality of life at the 2, 4, and 8-week marks, in contrast to those in the vehicle arm, based on Dermatology Life Quality Index (DLQI) measurements (odds ratio (OR) 6.97; 95% confidence interval (CI) 3.97, 12.24; P<0.001).

In the span of only 2 weeks, the STRATUM investigators had observed that 72.5% of subjects in the study showed a minimally important difference in their DLQI scores, with this amount rising to 86.6% by the study's end at 8 weeks. This contrasted with 28.1% P=0.001 and 53.6% P=0.001 for those in the vehicle arm at each point, respectively.

The STRATUM study also indicated the drug had a favorable safety and tolerability profile, with reports of Treatment Emergent Adverse Events (TEAEs) being shown to be low and similar between both treatment and vehicle cohorts. It was also noted that most TEAEs were shown to be of mild to moderate severity.

“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,” Patrick Burnett, MD, PhD, Arcutis chief medical officer, said in a statement.

Roflumilast foam, 0.3%, was approved by the US Food and Drug Administration (FDA) in December of 2023 for patients 9 years and older with seborrheic dermatitis. The approval by the FDA had been based upon the favorable data seen in Arcutis' phase 2 and pivotal phase 3 trials STRATUM and Trial 203.2

These new results from the subgroup analysis contribute to dermatologists’ awareness of this treatment as a potential addition to the armamentarium for seborrheic dermatitis patients.

References

  1. ZORYVE® (Roflumilast) Topical Foam, 0.3% Clears Seborrheic Dermatitis in Individuals Who Previously Reported an Inadequate Response to Topical Steroids. Arcutis Biotherapeutics. 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/. Date accessed: January 14, 2024.
  2. Smith T. FDA Announces Approval of Roflumilast Foam for Seborrheic Dermatitis. HCPLive. December 15, 2023. https://www.hcplive.com/view/fda-announces-approval-of-roflumilast-foam-for-seborrheic-dermatitis. Date accessed: January 14, 2024.
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