Patrick Burnett, MD, PhD, Outlines Arcutis' Pediatric Strategy for Roflumilast in AD and Psoriasis

In a recent interview with Dermatology Times, Patrick Burnett, MD, PhD, Chief Medical Officer of Arcutis Biotherapeutics and a practicing dermatologist, outlined significant advances in the company’s pediatric development program for topical roflumilast (Zoryve). He highlighted 2025 as a pivotal period in expanding safe, effective, steroid-sparing options for children with atopic dermatitis (AD) and plaque psoriasis.

A major milestone this year was the FDA approval of roflumilast 0.05% cream as a once-daily, nonsteroidal treatment for mild-to-moderate AD in children aged 2 to 5 years. This extends the therapeutic reach beyond the previously approved 0.15% strength for patients ≥6 years. Burnett emphasized the scarcity of well-tolerated treatments in younger pediatric age groups and reported strong enthusiasm from clinicians using the lower-strength formulation in this population.

Arcutis has also completed enrollment of the INTEGUMENT-INFANT phase 2 trial, evaluating roflumilast 0.05% cream in infants aged 3 to 24 months with mild to moderate AD. Burnett noted unusually rapid enrollment—contrasting with prior recruitment challenges in 2–5-year-olds—reflecting clinicians’ growing familiarity with the medication and increasing parental desire for steroid-sparing approaches. Study results are anticipated in early 2026.

For plaque psoriasis, the company recently secured FDA approval of roflumilast 0.3% cream for patients ≥ 12 years and has submitted a supplemental New Drug Application to extend roflumilast 0.3% cream approval to children aged 2 to 5 years. If accepted, it would become the first PDE4 inhibitor approved for psoriasis in this age group. The FDA has assigned a PDUFA target date of June 29, 2026.

Burnett framed Arcutis’ long-term pediatric strategy as an effort to minimize cumulative lifetime exposure to topical corticosteroids, previously the default standard for chronic inflammatory dermatoses. He highlighted emerging evidence on the potential systemic risks of chronic steroid use, including metabolic and bone-related effects, underscoring the importance of early access to effective nonsteroidal therapies.
“I think it's incumbent upon us then to do the pediatric development that we're doing right now and make sure that we can shorten that exposure and really try to contribute to a lifetime of health for patients,” Burnett said.

Offering guidance to clinicians, Burnett stressed that caring for pediatric patients requires considering the entire family’s needs, expectations, and treatment capacity. Parents may be more hesitant about steroids for their children than for themselves, making regimen acceptability crucial. He encouraged clinicians to take a long-view approach; selecting therapies that not only control current disease but also support healthier long-term trajectories for children who may face decades of ongoing management.