How Roflumilast Cream Fits into Plaque Psoriasis Care Strategy

Last week, the US Food and Drug Administration (FDA) approved roflumilast cream (ZORYVE) for the treatment of adult and adolescent plaque psoriasis.

The approval granted to Arcutis Biotherapeutics for its once-daily topical PDE4 inhibitor is a novel indication for such a pathway-targeting dermatology agent delivered via skin. It’s also supported by late-stage data showing a majority of treated patients report statistically significant improvements in measures of psoriasis area and itching intensity over 8 weeks.

But the true use of this new psoriasis option is yet to be understood.

In the second segment of an interview with HCPLIve, Raj Chovatiya, MD, PhD, director of the Center for Eczema and Itch at Northwestern University Feinberg School of Medicine, said based on phase 3 DERMIS trial data alone, roflumilast cream may be considered a first-line treatment for psoriasis, “particularly in places where people have psoriasis where you’re just limited by the topical steroid of choice.”

But there’s much more context to a drug than supporting data.

“With new therapies, there’s always some degree of real-world reticence, with people wanting to figure out how it’s going to fit into their therapies, and people comfortable with what they already know,” Chovatiya said. “From a practical standpoint, I assume that many of the people who will use roflumilast have used some kind of topical steroid previously, but I would hope that the way that the indication and statement label comes allows it the broadest possible use to allow us to get the best treatment to the right kind of patient.”

Chovatiya expressed interest in learning how factors such as treatment cost and access via insurance will be resolved, as well as roflumilast cream’s dynamic in the whole psoriasis treatment strategy. Chief among his questions include whether it may be used in combination with systemic therapy, phototherapy or oral agents. Additionally, he prosed whether there will be strategy or rationale to discontinue care for patients who achieve long-term skin clearance.

As long-term data that Chovatiya currently describes as “reassuring” accumulates for roflumilast cream, the dermatologist stressed the importance of making a significant regulatory breakthrough for a topical drug—amid an era of increasing oral and injectable options for patients.

“(Topical therapies) just work, are practical and safe in a lot of patients,” he said. “And it’s nice to see that we’re now thinking almost patient-centered in how we design that product that patients are going to want to use, they are easy to prescribe and bottom-line are just going to work.”