During an interview segment with HCPLive, Lawrence Eichenfield, MD, described the background of two phase 3 trials on roflumilast for adults and children with atopic dermatitis (AD).¹

The contents of his discussion were presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans.

Eichenfield is the chief of pediatric and adolescent dermatology for Rady Children's Hospital-San Diego, as well as professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine.

“Roflumilast is a is a new product being developed for atopic dermatitis with other use of this molecule previously approved for psoriasis (for ages 12 and up), and these are core studies looking at this PDE4 inhibitor for atopic dermatitis,” Eichenfield said.

Eichenfield went on to describe a bit about the treatment itself and its properties.

“Roflumilast is a PDE4 inhibitor,” he said. “In vitro assays show that it seems to have a greater affinity for PDE4 than other PDE4s of, for instance, apremilast or crisaborole, in the in vitro assays. So it was expected that it could be a potent anti-inflammatory for atopic dermatitis.”

Eichenfield then explained the details of both of the studies from which he drew the data he presented at the conference.

“I presented the data on INTEGUMENT-1 and INTEGUMENT-2 because, as is typical, we do 2 parallel studies, in this particular case using the same design,” he explained. “And these are traditional randomized, vehicle controlled studies. And these studies were of roflumilast cream at a 0.15% concentration. And studies were designed to use this product on a once a day basis with a four-week dosing schedule.”

Additionally, Eichenfield explained the way in which both trials were set up for assessment of the AD treatment.

“So first of all, patients with atopic dermatitis from ages 6 and older, they had to have mild to moderate atopic dermatitis,” he said. “In a validated IGA scale and Global Investigator Scale, they had to be at 2, which is mild dermatitis, or 3, which is moderate atopic dermatitis and entry. They had to have at least 3% body surface area or greater, and their Eczema Area Severity Index score had to be greater than 5.”

For more information on Eichenfield’s findings, view the interview segment above.

References

1. Eichenfield L, et al. Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥6 with mild to moderate atopic dermatitis in two phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2). Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17 – 21. New Orleans, LA. Accessed March 19, 2023.