Roflumilast 0.15% taken once-daily was effective at improving atopic dermatitis (AD) across multiple efficacy endpoints and produced favorable safety and tolerability, according to new trial data.¹

This late-breaking data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans, LA. The data was the result of the INTEGUMENT-1 and INTEGUMENT-2 studies.

The data was presented by Lawrence Eichenfield, MD, who serves as chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and is known for his work as professor and vice-chair of the department of dermatology at UC San Diego School of Medicine.

The investigators also found that adverse events (AEs) were reported in less than 3.5% of patients, and the incidence of application site pain was found to be low.

In INTEGUMENT-1, the investigators noted that occurrence of application site pain was reported in 2.1% and 0.5% of participants given roflumilast and given the vehicle, respectively. Similarly, in INTEGUMENT-2, the incidence of application site pain was reported in 0.9% of patients in both treatment groups.

The investigators also reported that over 90% of patients in both of the trials given roflumilast reported no or mild sensation, indicating favorable local tolerability at any point in time.

“That data looked quite good in both of the clinical studies, meeting statistical significance,” Eichenfield said in an interview with HCPLive. “And the improvement in itch with roflumilast 0.15% was significant 24 hours after the first application.”

The INTEGUMENT-1 and INTEGUMENT-2 studies assessed patients with AD aged ≥6 years and with a baseline Eczema Area and Severity Index (EASI) score of ≥5 and a Validated Investigator Global Assessment-AD (vIGA-AD) score of mild or moderate.

The investigators randomly assigned participants were to receive once-per-day roflumilast 0.15% or vehicle for a total of 4 weeks. The primary endpoint was vIGA-AD success, with a score of 0 or 1 with 2-grade improvement from baseline at 4 weeks. The secondary endpoint was defined as 75% improvement in EASI (or EASI-75).

The study found that a significantly higher number of patients in the roflumilast group achieved vIGA-AD Success and EASI-75 compared to the vehicle group in both trials. The incidence of treatment-emergent adverse events was low in both treatment groups and most of these events were mild to moderate in severity.

“I think that we'll be figuring out how it fits into regimens of care,” Eichenfield said. “But it's nice to have what looks to be robust efficacy with a product that brings along safety and good tolerability.”

For more information on the data, view the HCPLive interview with Eichenfield 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.