Based on recent positive phase 3 results, Arcutis Biotherapeutics,. intends to submit a supplemental New Drug Application with the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.
In the pivotal INTEGUMENT-PED (NCT04845620) phase 3 trial, roflumilast cream 0.05% (Arcutis Biotherapeutics, Inc.) met the primary and all secondary outcomes in children aged 2 to 5 years with mild to moderate atopic dermatitis (AD), according to a press release from the manufacturer.
The steroid-free, once-daily topical cream is formulated to deliver the drug without skin barrier disruption. In the trial, which enrolled 652 children aged 2 to 5 years with a 22% overall mean Body Surface Area (BSA), and a range from 3% to 82%, roflumilast cream 0.05% achieved Investigator Global Assessment (IGA) Success in 25.4% of children. IGA, the primary endpoint, was 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. The IGA Success of 25.4% was compared to 10.7% observed with vehicle (P < .0001). Significant improvements were observed as early as week 1.
“Pediatric atopic dermatitis is a chronic, recurrent inflammatory skin condition that can negatively impact the quality of life of the child and family or caregivers,” said Adelaide A. Hebert, MD, chief of Pediatric Dermatology, McGovern Medical School at UTHealth Houston, and INTEGUMENT-PED investigator, in the press release. “The positive findings from this study of roflumilast cream are highly consistent with the findings from the INTEGUMENT-1 and INTEGUMENT-2 studies. These results further reinforce the safety and efficacy profile of roflumilast cream as a potential treatment option, if approved, for pediatric atopic dermatitis down to 2 years of age.”
All secondary outcomes for roflumilast cream 0.05% were met, “with significant improvements seen across all time points including vIGA-AD success and vIGA-AD of ‘clear’ and ‘almost clear’ at week 1.” Of children treated with roflumilast cream 0.05%, 39.4% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at week 4, compared to vehicle improvement of 20.6% (P < .0001). At week 4, 35.3% of roflumilast cream-treated children achieved a 4-point reduction in Worst Itch Numeric Scale (WI-NRS), compared to 18.0% for vehicle-treated children (nominal P = .0002).
Adverse events incidence was low in the INTEGUMENT-PED trial. Upper respiratory tract infection was the only adverse event occurring in more than 3% of participants in either arm. For the roflumilast cream arm, upper respiratory tract infection, pyrexia, vomiting, and diarrhea were the most frequent adverse events, occurring in 2% or more of participants.
Arcutis recently submitted a supplemental New Drug Application (sNDA) to the FDA for roflumilast cream 0.15% to treat mild to moderate AD in children 6 years and up. Based on positive results, Arcutis plans to submit a sNDA with the FDA for roflumilast cream 0.05%.
Arcutis announces positive results from INTEGUMENT-PED pivotal phase 3 trial of roflumilast cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. Arcutis Biotherapeutics, Inc. Press release. September 19, 2023. Accessed September 20, 2023.