Melinda Gooderham, MD: Effects of Roflumilast Foam on Scalp, Body Psoriasis

Arcutis Biotherapeutics announced July 23 that a supplemental new drug application (sNDA) had been submitted to the US Food and Drug Administration (FDA) for roflumilast (Zoryve) foam 0.3%.¹ This drug was designed for adult and adolescent patients 12 years of age and older with scalp and body psoriasis.

Roflumilast foam is a next-generation phosphodiesterase-4 (PDE4) inhibitor which is intended to be taken once-per-day.² The drug’s sNDA resulted from the conclusions of the pivotal ARRECTOR phase 3 trial, a vehicle-controlled, double-blind study assessing the safety and efficacy of roflumilast foam 0.3%.

Melinda Gooderham, MD, MSc, is a dermatologist for the SKiN Centre for Dermatology in Peterborough, Ontario. Gooderham spoke with the HCPLive editorial team about the lead up to the sNDA submission, highlighting findings of ARRECTOR and its implications.

“The study included patients who were 12 years and above,” Gooderham explained. “They were required to have psoriasis in both the scalp and the body. For the scalp, the IGA had to be at least moderate or severe. And for the body, psoriasis had to be at least mild, moderate, or severe, and less than 25% body surface area involvement.”

Scalp-Investigator Global Assessment (S-IGA) and Body-Investigator Global Assessment (B-IGA) success were both the co-primary endpoints of the study. Gooderham was asked about the main findings and what they could mean for patients.

“Great results with this trial,” Gooderham said. “I’ll start by saying, for the Scalp-IGA, about 85% of patients had moderate and 15% had severe disease. Then in the Body-IGA, about a quarter of patients had mild, so those are the ones that had to get to be clear, and two thirds of patients were in the moderate category. But for IGA success, two thirds of patients achieved IGA success of the scalp, which is great…in a very difficult-to-treat area such as the scalp. And then for the body, it was 45% IGA success.”

Gooderham also highlighted the findings suggesting 46.5% B-IGA success among those given roflumilast versus 20.8% in the vehicle arm.

“The other important outcomes for this trial were with pruritus, which is also a huge problem for scalp psoriasis,” Gooderham said. “One of the issues with pruritus is that patients will scratch or rub the area and actually koebnerize scalp psoriasis, so itch improvement in that area is quite a significant thing…But I think for me, one of the most interesting findings from this trial is that (Scalp Itch Numeric Rating Scale) was significantly better than the vehicle within 24 hours, so that immediate itch relief for some patients will improve adherence.”

To learn more about Gooderham’s interview, view the full discussion posted above.

The quotes contained in this interview were edited for the purposes of clarity.

Melinda 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. ^{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: July 30, 2024.}
2. ^{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 30, 2024.}