Roflumilast Topical Foam, 0.3% and Full STRATUM Results, with Andrew Blauvelt, MD, MBA

The late December 2023 approval of roflumilast topical foam, 0.3% (Zoryve) transformed the management of seborrheic dermatitis, with the approval ushering in the first new mechanism of action in management in more than 20 years.

Approved for patients aged 9 years and older, the US FDA’s decision was based on results of the phase 3 STRATUM trial, which concluded 80% of patients using roflumilast topical foam, 0.3% achieved Investigator Global Assessment (IGA) Success and more than half achieved complete clearance at week 8.¹

“Despite being very common, seborrheic dermatitis has traditionally been a disease with limited treatment options. It also can have a significant impact on quality of life,” said Andrew Blauvelt, MD, MBA, lead investigator of STRATUM and a dermatologist at the Oregon Medical Research Center.² “The publication of the Phase 3 STRATUM study results in the Journal of American Academy of Dermatology further validates the significance of roflumilast foam as a new treatment option for [seborrheic dermatitis], one that provides treatment success in eight of ten patients, along with significant and rapid improvements in key signs and symptoms of disease, as early as two weeks. These results highlight the effectiveness and safety of roflumilast foam, a steroid-free treatment and the first novel mechanism of action approved for [seborrheic dermatitis] in two decades. It should end suffering from this long-neglected condition.”

A parallel group, double-blind, vehicle-controlled study, the STRATUM trial enrolled 457 adults and adolescents with moderate to severe seborrheic dermatitis affecting up to 20% body surface area and randomized them to roflumilast topical foam, 0.3% or vehicle for 8 weeks. The primary outcome of interest for the trial was IGA success, which investigators defined as an IGA score of clear or almost clear plus an improvement of 2 or more grades from baseline.¹

Topline results of the trial were announced in June 2022 and full results were published in the Journal of American Academy of Dermatology in January 2024. Of note, the publication of full trial results comes just 7 days after Arcutis Therapeutics announced the agent was now available in the US.^3,4

Results of the trial demonstrated the rate of IGA success was 79.5% with roflumilast topical foam, 0.3% and 58.0% with vehicle (P <.0001). Further analysis pointed to statistically significant differences in IGA Success favoring roflumilast at week 2 (43.0% vs 25.7%; P < .001) and week 4 (73.1% vs 47.1%; P <.001).¹

Analysis of additional endpoints suggested 50.6% of patients receiving roflumilast topical foam, 0.3% achieved completed clearance at week 8 and roflumilast topical foam, 0.3% was associated with statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema.¹

Following the full publication in the Journal of American Academy of Dermatology, the editorial team of HCPLive Dermatology reached out to Blauvelt to learn more about how results might inform use. That conversation is the subject of the following video interview.

Relevant disclosure for Blauvelt include AbbVie, Eli Lilly and Company, Arcutis, Boehringer Ingelheim, and more.

References:

1. Blauvelt A, Draelos ZD, Stein Gold L, et al. Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial. J Am Acad Dermatol. Published online January 20, 2024. doi:10.1016/j.jaad.2023.12.065
2. Arcutis Biotherapeutics. Journal of the American Academy of Dermatology publishes ZORYVE (roflumilast) foam, 0.3% results for seborrheic dermatitis from pivotal phase 3 trial. Arcutis Biotherapeutics. January 29, 2024. Accessed January 30, 2024. https://investors.arcutis.com/news-releases/news-release-details/journal-american-academy-dermatology-publishes-zoryve.
3. Arcutis Biotherapeutics. Arcutis announces positive topline results from stratum pivotal phase 3 trial of roflumilast foam 0.3% in seborrheic dermatitis. Arcutis Biotherapeutics. June 6, 2022. Accessed January 30, 2024. https://www.arcutis.com/arcutis-announces-positive-topline-results-from-stratum-pivotal-phase-3-trial-of-roflumilast-foam-0-3-in-seborrheic-dermatitis/.
4. Arcutis Biotherapeutics. ZORYVE® (ROFLUMILAST) topical foam, 0.3%, for the treatment of seborrheic dermatitis launches in the United States. Arcutis Biotherapeutics. January 22, 2024. Accessed January 30, 2024. https://www.arcutis.com/zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-launches-in-the-united-states/.