Lawrence Eichenfield, MD

Credit: Rady Children's Hospital

About 91.5% of those with atopic dermatitis (AD) saw improvement in their scores on the Eczema Area and Severity Index (EASI) after 4-weeks of treatment with roflumilast cream, 0.15%, according to new findings.¹

These findings were presented at the 2024 Winter Clinical Dermatology Conference in Hawaii, resulting from pooled analyses of the 2 pivotal phase 3 INTEGUMENT-1 and INTEGUMENT-2 studies. These trials looked at treatment of AD with the once-per-day, steroid-free cream for adults and children aged 6 years and older.

Both INTEGUMENT 1 and 2 were parallel group, double-blinded, and vehicle-controlled studies which had been conducted to look into the effectiveness and safety of the drug in those with AD.

“These individual patient response data can give confidence to clinicians that roflumilast cream can provide predictable and effective improvement of atopic dermatitis, with 70% of adults and children achieving EASI-50 and nearly one in four achieving 90% or greater improvement in eczema area and severity,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and trial investigator, said in a statement.

A substantial increase was seen after 4 weeks, with study participants reporting a 50% EASI score (EASI-50) reduction among 69.2% of those treated with roflumilast, versus 44.4% in the vehicle arm (P<0.0001). By the same 4-week endpoint, the investigators reported a 75% EASI score (EASI-75) reduction was among 44.5% of the treatment arm versus 21.2% in the vehicle arm (P<0.0001).

The investigators noted that EASI-90 had been seen among 22.4% of roflumilast-treated individuals versus 8.6% among the vehicle cohort (P<0.0001), and a complete 100% reduction (EASI-100) was observed in 9.8% of patients using roflumilast compared to 4.8% among the vehicle group (P<0.002).

Both the tolerability and safety of roflumilast 0.15% were found by the research team to have been comparable to the profiles of the vehicle. The findings indicated that the therapy led to lower rates of application site adverse events (AEs), treatment-related AEs, and discontinuations resulting from AEs.

“These data demonstrate the rapid and reliable efficacy of roflumilast cream in atopic dermatitis with the majority of individuals achieving measurable improvement in EASI in as little as one week,” Patrick Burnett, MD, PhD, the chief medical officer of Arcutis, said in a statement.

Some of the most frequently reported AEs were headaches among 2.9%, nausea among 1.9%, pain at the site of treatment application among 1.5%, diarrhea among 1.5%, and vomiting among 1.5%.

“If approved, the consistent efficacy with daily application over a four week period combined with a tolerability and safety profile without limitations on body regions or duration treated will make this a great addition for management of pediatric and adult atopic dermatitis,” Lawrence Eichenfield, MD, explained in a statement.

References

1. ^{Majority of Individuals with Atopic Dermatitis Improved with Arcutis’ Roflumilast Cream 0.15% According to New Data from Phase 3 Program. Arcutis Biotherapeutics. January 14, 2024. https://www.arcutis.com/majority-of-individuals-with-atopic-dermatitis-improved-with-arcutis-roflumilast-cream-0-15-according-to-new-data-from-phase-3-program/. Date accessed: January 15, 2024.}