Discussing atopic dermatitis, roflumilast cream 0.15% with Russell Libby, MD, FAAP

Atopic dermatitis (AD) remains a persistent challenge for pediatric patients, often beginning in infancy and continuing into childhood. “Somewhere between 7, 8, 10% of kids will have episodic and some of them rather severe and chronic eczema,” said Russell Libby, MD, FAAP, founder and president of Virginia Pediatric Group.

On July 9, 2024, the FDA approved roflumilast 0.15% (ZORYVE; Arcutis Biotherapeutics) for children aged 6 years and older, providing a new non-steroidal option for managing AD. Libby emphasized the need for alternatives to corticosteroids, stating, “We get nervous using steroids all the time, especially as they get more potent, and parents worry that they don't know what regimen to use. They don't know how to maintain, [as] sometimes it gets difficult.”

While systemic treatments like dupilumab (Dupixent; Sanofi and Regeneron Pharmaceuticals) have transformed care for severe cases, not all patients require immune suppression.

“[Dupilumab] has come along, and for those with the chronic issues, it has been a godsend for those with really severe and ongoing, chronic, severe AD, but nonetheless, there are those who are less severe and don't really want to go on immune suppressants and are looking for topicals,” Libby explained.

As a phosphodiesterase-4 (PDE4) inhibitor, roflumilast cream 0.15% targets inflammation directly on the skin without the risks associated with long-term steroid use. Libby highlighted the favorable tolerability profile of roflumilast compared to older non-steroidal treatments like tacrolimus, noting, “From what I can see reading about roflumilast, is that it really is a better tolerated medication. It has the same kind of impact on one of the pathways in the inflammatory routine, but it seems to have a pretty good response.”

He further stressed the psychological and physical burden of AD, describing it as “an incredibly invasive disease," he said. "You're chronically self-conscious of your skin. It bothers you to sleep well. You worry about allergens... food allergies, etc. It makes you much more comfortable if your skin feels good.”

Libby concluded by emphasizing the holistic impact of AD on patients and families. “AD is not just your skin. It is your family having to deal with it. Your sleep being affected by it. You're constantly itching... secondary infection, bleeding... They are real issues that really do deserve our compassion, our attention and our treatment.”

Reference:

Fitch, J. FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and up, Contemporary Pediatrics. July 9, 2024. Accessed December 24, 2024. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-cream-0-15-atopic-dermatitis-patients-aged-6-years-older