New Findings on Psoriasis Outcomes for Roflumilast Foam 0.3%, with Melinda Gooderham, MD

New data from the phase 3 ARRECTOR study has been presented on roflumilast foam 0.3% (Zoryve) for treatment of adults and adolescents aged 12 years and older with psoriasis, following the July submission of a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast foam.^1,2

New data on the topical foam, a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor, has been presented at the Fall Clinical Dermatology Conference in Las Vegas regarding patient-reported outcome data on the medication’s use. In this interview, Melinda, Gooderham, MD, MSc, a dermatologist for the SKiN Centre for Dermatology in Ontario, spoke about the trial and the new findings.

“Roflumilast is a PDE4 inhibitor, a highly potent PDE4 inhibitor,” Gooderham explained. “We are familiar with that class, with an oral therapy, Otezla, that's approved for the treatment of moderate-to-severe plaque psoriasis. We also have a topical PDE4 inhibitor approved for atopic dermatitis. We have roflumilast cream at a 0.15% concentration approved for atopic dermatitis in the United States. So this is a non-steroidal option for patients to use.”

Gooderham noted several characteristics of the topical medication itself, highlighting its efficacy and comparing it to other drugs.

“It's a once daily formulation, and both the cream and the foam are aesthetically pleasing in that they're not greasy and they are about 50% water,” Gooderham said. “So when it's put on the skin and rubbed in, it really sort of disappears and provides the medication without leaving that sticky feeling that patients often complain about. It’s also the convenience of having a once-a-day product that can be used in all locations sort of makes this product stand out from some of the others.”

The phase 3 data from ARRECTOR trial, a vehicle-controlled, double-blind study which evaluated the safety and efficacy of roflumilast foam 0.3%, was detailed in a prior interview.¹ In this interview, Gooderham detailed these findings and those recently-presented concerning patient-reported outcomes.

“The latest data to be presented recently at the Fall Clinical meeting was that of the patient reported outcomes,” Gooderham said. “We saw some great photos showing the efficacy of the product, but from the patient's perspective, there were really great results. As far as itch, we know that itch and psoriasis, especially on the scalp, is a significant issue. The more patients scratch at their scalp, the more they can koebnerize it and make it worse.”

Gooderham highlighted the flakes that will then be observed on patients’ clothing as a result.

“What the ARRECTOR trial showed with roflumilast foam was that about over 50% of patients actually had, in the Worst Itch NRS and the Scalp Itch NRS, was 0 or 1. So they had no or minimal itch on the scalp or or overall in the body after 8 weeks of using roflumilast foam.”

The findings also suggested treatment with roflumilast foam 0.3% was linked to lower rates of adverse events. There were also few discontinuations of the drug due to adverse events and comparable local tolerability to vehicle.

To learn more about recent ARRECTOR trial findings, view the full interview segment posted above. For more about Fall Clinical Conference data, view our latest coverage here.

The quotes used in this interview summary were edited for clarity.

Gooderham has reported non-financial support from Arcutis during the study; and personal fees from Aceylrin, AbbVie, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Meiji, Dermavant, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, Apogee, AnaptysBio, Aristea, and L'Oreal.

References

1. ^{Smith T. Melinda Gooderham, MD: Effects of Roflumilast Foam on Scalp, Body Psoriasis. HCPLive. July 30, 2024. https://www.hcplive.com/view/melinda-gooderham-effects-roflumilast-foam-scalp-body-psoriasis. Date accessed: November 1, 2024.}
2. ^{Smith T. Arcutis Submits sNDA for Roflumilast Foam as Treatment for Scalp, Body Psoriasis. HCPLive. July 23, 2024. https://www.hcplive.com/view/arcutis-submits-snda-roflumilast-foam-treatment-scalp-body-psoriasis. Date accessed: November 1, 2024.}