Topline results were announced from a phase 3 trial evaluating roflumilast cream, a topical phosphodiesterase-4 (PDE4) inhibitor, in patients with mild to moderate atopic dermatitis.
The INTEGUMENT-1 trial (ClinicalTrials.gov Identifier: NCT04845620) enrolled 654 patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area. Patients were randomly assigned to receive roflumilast cream 0.15% or vehicle applied once daily for 4 weeks. The primary endpoint of the study was Investigator Global Assessment (IGA) success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4.
Results showed 32.0% of patients treated with roflumilast cream achieved IGA success compared with 15.2% of patients treated with vehicle (P <.0001). The study also met key all secondary endpoints. Findings showed that 43.2% of patients in the roflumilast arm achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) at week 4 compared with 22.0% of patients in the vehicle arm (P <.0001). Improvements in itch were also noted in individuals 12 years of age and older, with 33.6% of patients treated with roflumilast cream achieving a 4-point reduction in Worst Itch Numeric Scale at week 4 vs 20.7% for vehicle-treated patients (P <.01).
“Today’s positive data from INTEGUMENT-1 adds to the growing body of evidence for the overall potential of roflumilast cream as an effective and well-tolerated treatment in atopic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer of Arcutis. “Roflumilast cream is a next-generation PDE4 inhibitor that was well tolerated and safe in this trial, providing rapid and robust clearance of the disease as well as reduction in itch.”
Topline results from an identical phase 3 trial, INTEGUMENT-2 (ClinicalTrials.gov Identifier: NCT04773600), are expected by the end of 2022. Data from both studies will form the basis of a supplemental New Drug Application for roflumilast cream 0.15% in atopic dermatitis.
Roflumilast cream 0.3% is currently marketed under the brand name Zoryve for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
Arcutis announces positive topline results from INTEGUMENT-1 pivotal phase 3 trial of roflumilast cream in atopic dermatitis in adults and children aged six years and older. News release. November 15, 2022. https://www.globenewswire.com/en/news-release/2022/11/15/2556479/0/en/CORRECTION-Arcutis-Announces-Positive-Topline-Results-from-INTEGUMENT-1-Pivotal-Phase-3-Trial-of-Roflumilast-Cream-in-Atopic-Dermatitis-in-Adults-and-Children-Aged-Six-Years-and-Ol.html.