Takeaways:
- Roflumilast cream 0.15% led to 91.5% of individuals treated with it to an improvement in Eczema Area and Severity Index (EASI) at 4 weeks.
- The once-daily, steroid-free cream is being investigated for atopic dermatitis in adults and children aged 6 years and older.
- Pooled analyses of 2 phase 3 studies formed the basis of a supplemental New Drug Application (sNDA), accepted by the FDA in November 2023.
- Roflumilast-treated patients showed statistically higher percentages in achieving EASI-50, EASI-75, EASI-90, and EASI-100 compared to the vehicle.
- Individual patient response data suggest roflumilast cream can provide predictable and effective improvement in atopic dermatitis, with 70% achieving EASI-50 and nearly one in four achieving 90% or greater improvement.
According to new data presented at the 2024 Winter Clinical Dermatology Conference in Hawaii, roflumilast cream 0.15% (Arcutis Biotherapeutics) treatment led 91.5% of individuals to achieve a measurable improvement in Eczema Area and Severity Index (EASI) at 4 weeks, according to individual patient responses.
Data for the once-daily, steroid-free cream being investigated for adults and children aged 6 years and up with atopic dermatitis, is from a pooled analyses of the 2 phase 3 studies (INTEGUMENT-1[NCT04773587] and INTEGUMENT-2 [NCT04773600]). These studies formed the basis of a supplemental New Drug Application (sNDA), which the FDA accepted in November 2023.
Based on observed data, a statistically greater percentage of patients achieved a 50% reduction in EASI scores (EASI-50) at week 4, with 69.2% of roflumilast-treated patients compared to 44.4% vehicle (P < 0.0001).
A 75% reduction in EASI score (EASI-75) was achieved in 44.5% of roflumilast-treated patients compared to 21.2% of vehicle-treated patients (P < 0.0001). EASI-90 was observed in 22.4% of roflumilast-treated patients compared to 8.6% of vehicle-treated patients (P < 0.0001).
A 100% reduction (EASI-100) was observed in 9.8% of patients treated with roflumilast vs 4.8% treated with vehicle (P < 0.002), according to Arcutis.
“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,” said Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology, Rady Children's Hospital-San Diego; professor of Dermatology and Pediatrics, vice-chair, Department of Dermatology, UC San Diego School of Medicine, and study investigator.
“If approved, the consistent efficacy with daily application over a [4-]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.”
Following the acceptance of the sNDA, Eichenfield spoke with Contemporary Pediatrics in a video interview, saying in part, “The announcement of the FDA accepting the sNDA for roflumilast [0.15%], plus other work with that drug and other drugs, with different formulations and different agents, I think will be very important going forward to have a newer set of nonsteroidal medicines for atopic dermatitis.”
Click here, or the picture below to watch the full interview.
Safety and tolerability data for roflumilast cream 0.15% were comparable with vehicle. Low rates of application site adverse events, treatment-related adverse events, and discontinuations because of adverse events were observed.
Additional roflumilast coverage on Contemporary Pediatrics:
Roflumilast cream 0.3% (ZORYVE) is currently approved by the FDA to topically treat plaque psoriasis in patients aged 6 years and up.
Roflumilast cream 0.3% is also approved to treat seborrheic dermatitis patients aged 9 years and up.
Roflumilast cream 0.05% was also shown to be effective in treating atopic dermatitis in children aged 2 to 5 years. Click here to read more.
Reference:
Majority of individuals with atopic dermatitis improved with arcutis’ roflumilast cream 0.15% according to new data from phase 3 program. Arcutis Biotherapeutics. Press release. January 14, 2024. Accessed January 16, 2024. https://investors.arcutis.com/news-releases/news-release-details/majority-individuals-atopic-dermatitis-improved-arcutis
