Majority of Patients Treated With Roflumilast Cream 0.15% for AD Demonstrate Improvement in EASI Scores at 4 Weeks

New data from pooled analyses of Arcutis’ 2 phase 3 INTEGUMENT-1 and INTEGUMENT-2 studies demonstrated that the majority of patients (91.5%) treated with investigational roflumilast 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks. The new data of roflumilast cream 0.15%, a once-daily, steroid-free cream being investigated for adults and children aged 6 years and older with atopic dermatitis (AD), was presented at the 2024 Winter Clinical Hawaii Dermatology Conference in Honolulu, Hawaii, held January 12th through the 17th.¹

According to the announcement, at week 4, a statistically significant greater percentage of patients achieved a 50% reduction in EASI scores (EASI-50), with 69.2% of patients treated with roflumilast cream compared to 44.4% of patients treated with vehicle (P<0.0001) based on observed data. At the same 4-week endpoint, a 75% reduction in EASI scores (EASI-75) was achieved in 44.5% of roflumilast-treated patients compared to 21.2% of vehicle-treated patients (P<0.0001). Most notably, a 90% reduction in EASI scores (EASI-90) was observed in 22.4% of patients treated with roflumilast cream compared to 8.6% of vehicle-treated patients (P<0.0001) and a 100% reduction (EASI-100) was observed in 9.8% of patients treated with roflumilast cream compared to 4.8% of vehicle-treated patients (P<0.002).

“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. 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,” said Lawrence Eichenfield MD, the chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, and study investigator, in the news release.

In November 2023, the US Food and Drug Administration (FDA) accepted Arcutis’ supplement new drug application (sNDA) for roflumilast cream 0.15% for the treatment of AD. With the acceptance, the FDA has also set a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2024. The sNDA is supported by positive safety and efficacy data from 3 phase 3 programs, including INTEGUMENT-1 and INTEGUMENT-2, a phase 2 dose-ranging study, and 2 phase 1 studies assessing the pharmacokinetics of the phosphodiesterase-4 (PDE4) inhibitor.²

The safety and tolerability data of roflumilast cream 0.15% were comparable with vehicle, with low rates of application site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).¹

“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. We are pleased to be able to share these individual response data with the wider dermatology community, and develop a better understanding about the broad range of clinical response for roflumilast cream in this condition,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in the news release.

References

1. Majority of individuals with atopic dermatitis improved with Arcutis’ roflumilast cream 0.15% according to new data from phase 3 program. News release. Arcutis Biotherapeutics. January 14, 2024. Accessed 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/
2. FDA approves Arcutis’ ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. News release. Arcutis Biotherapeutics. December 15, 2023. Accessed January 14, 2024. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/