Majority of individuals with atopic dermatitis improved with roflumilast cream 0.15% according to new data from phase III program
Arcutis Biotherapeutics, Inc. announced new individual patient response data showing the vast majority of individuals (91.5%) treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks
New pooled analyses from two pivotal Phase III studies (INTEGUMENT-1 and INTEGUMENT-2) were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu, HI. Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis.
Results: 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 those 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). importantly, 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, 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.
“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,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “We are pleased to be able to share these individual response data with the wider dermatology community and develop a better understanding about the consistent clinical response to roflumilast cream for patients with atopic dermatitis.”
Roflumilast cream 0.15% safety and tolerability data 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%).
INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase III, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.
Poster Details: Roflumilast Cream 0.15% in Patients With Atopic Dermatitis: Individual Patient EASI Responses: Pooled INTEGUMENT 1 and INTEGUMENT 2 Phase III Trials. Simpson, E et al.
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