Melinda Gooderham, MD: What Do the New Roflumilast Foam Data Mean for Psoriasis Patients?

Following the announcement by Arcutis Biotherapeutics that they had submitted a supplemental new drug application (sNDA) for roflumilast (Zoryve) foam 0.3% treatment of scalp and body psoriasis to the US Food and Drug Administration (FDA), trial investigator Melinda Gooderham, MD, MSc, was interviewed by HCPLive.^1,2

In her previous discussion with the editorial team, Gooderham—a dermatologist for the Skin Centre for Dermatology in Peterborough, Ontario—highlighted her team’s conclusions about the drug’s use among adults and adolescents 12 years of age and older who have scalp and body psoriasis. The topical foam is a next-generation phosphodiesterase-4 (PDE4) inhibitor used once-daily.

The newly-submitted sNDA followed the end of the phase 3 ARRECTOR trial, a vehicle-controlled, double-blind study which evaluated the medication. In this interview segment, Gooderham spoke on the ARRECTOR findings and their meaning.

“What I think one of the major benefits of a product like roflumilast foam is the fact that it can be applied in hair-bearing areas as well as non-hair-bearing areas,” she explained. “So you can have one product for scalp and body psoriasis. It's once-a-day and it's well tolerated. One thing I didn't mention is the tolerability. More than 95% of patients reported good tolerability and the adverse effect profile was no different than the vehicle foam profile, so nothing new that we found with using last as a cream.”

Indeed, in the initially published results, toleration among patients was noted as strong, given the lower numbers of treatment emergent adverse events (TEAEs). Such events were also noted as being generally mild to moderate.

“But from the patient's perspective, it's convenient,” Gooderham said. “It's once-a-day. It's non greasy, so it's aesthetically-pleasing, which is also really an important feature for patients who are putting something all over their body and then getting dressed and going to work, or getting into their sheets at bedtime. Having a non-greasy product that's once-a-day, that's as effective or more effective than than currently available products, I think, really will make a difference for patients with psoriasis.”

Gooderham noted that the drug may even be used in combination therapy with systemic agents, adding that this is common with topical use. Later, she was asked about what the next steps would be for the drug.

“We do have the cream product that's available for body psoriasis,” Gooderham said. “I actually have some patients apply it to the scalp, because we don't have the scalp approved for that yet. But in the United States, there is also the foam that's approved for seborrheic dermatitis. So some patients who have psoriasis may also have seborrheic dermatitis and may have this product, so they may already be using it.”

For additional information regarding this treatment option, view the full interview above.

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

Gooderham has been an investigator, speaker and/or advisor for: AbbVie, Acelyrin, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Cara, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, InMagene, JAMP Pharma, Janssen, Kyowa Kirin, LEO Pharma, L’Oreal, MedImmune, Meiji, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx and Vyne.

References

1. ^{Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over. Arcutis. July 23, 2024. https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-for-zoryve-roflumilast-foam-to-the-fda-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/. Date accessed: July 31, 2024.}
2. ^{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: July 31, 2024.}