Roflumilast Cream 0.15% Safe for Long-Term Use in Atopic Dermatitis Patients

Adults and children aged ≥6 with atopic dermatitis (AD) treated with roflumilast cream, 0.15% saw positive long-term results, according to late-breaking data, remaining durable over the course of 52-weeks.¹

These data were presented at the Revolutionizing Atopic Dermatitis (RAD) 2024 Annual Meeting in Chicago. The findings from investigators led by Eric L. Simpson, MD, of Oregon Health & Science University, were the results of the INTEGUMENT-OLE trial (NCT04804605).

These positive results on roflumilast cream, including regarding individuals who transitioned to twice-per-week (BIW) dosing regimens, were consistent with prior trial data on the phosphodiesterase-4 inhibitor.² The drug has been evaluated as a non-steroidal topical option for daily utilization in patients with eczema, referred to here as atopic dermatitis interchangeably.

Background and Design

Simpson and colleagues’ INTEGUMENT-OLE study was designed as an open-label safety study which was done over a course of 52 weeks, with 658 participants included in the research who had reported mild-to-moderate atopic dermatitis. These subjects had also completed a previous 4-week vehicle-controlled, randomized, phase 3 study, choosing to continue or switch to a once-per-day roflumilast cream 0.15% dose in this extension study.

Participants who, at the 4-week mark, were able to achieve a score of 0 or ‘Clear’ on the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) were changed to a dosing regimen of BIW maintenance.

Simpson et al.’s main focus in this extension trial was on safety signals. The team’s secondary outcomes they assessed included subjects’ scores on the Worst Itch-Numeric Rating Scale (WI-NRS), vIGA-AD, and the Eczema Area and Severity Index (EASI), defining “Disease control” as the time frame in which participants maintained their vIGA-AD=0/1 on BIW dosing following their reaching of vIGA-AD=0.

Findings

Following the 56-week cumulative treatment course, the investigators reported that 36.7% of those included as subjects had been shown to have experienced treatment-emergent adverse events (AEs), most of which were considered to be mild to moderate. The AEs noted by the research team were found to have been treatment-related among 4.7% of participants, with 3.0% having discontinued due to these AEs.

Among the most commonly-reported AEs, it was reported by the team that >2% included COVID-19, nasopharyngitis, headaches, or upper respiratory tract infections. They also found that 55.7% of subjects, by the 52-week mark, had been found to have a vIGA-AD score of 0/1 (Clear/Almost Clear).

They also found that 61.1% of the participants were shown to have a ≥75% reduction in their scores on EASI, further noting that 53.6% were shown to have a reduction of ≥4-points in WI-NRS (among those aged ≥12 years that had a baseline WI-NRS which was ≥4).

Out of the 19.8% of individuals in the study who were able to achieve disease control, it was found by the investigators that half had maintained this status for a minimum of 281 days.

References

1. ^{Simpson E, Eichenfield L, Berk D, et al. Long-term Safety and Efficacy of Roflumilast Cream 0.15% in Adults and Children Aged ≥6 Years With Mild to Moderate Atopic Dermatitis: A 52-week, Phase 3, Open-Label Extension Trial. Revolutionizing Atopic Dermatitis (RAD) 2024 Annual Meeting June 8 – 10, 2024. Chicago, IL.}
2. ^{Arcutis Biotherapeutics, Inc. Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD). https://www.arcutis.com/arcutis-announces-positive-long-term-results-of-roflumilast-cream-0-15-showing-durable-and-improved-efficacy-over-time-and-favorable-safety-profile-in-treatment-of-mild-to-moderate-atopic-dermatitis/. Published September 7, 2023.}