Roflumilast Cream Shows Durable Safety, Efficacy in Children with Atopic Dermatitis
Results from the INTEGUMENT-OLE phase 3 trial showed the therapy was also well-tolerated, with no new safety signals observed during treatment of up to 56 weeks.
Positive results have been announced from a phase 3 study evaluating the long-term safety and efficacy of roflumilast cream (Zoryve) 0.05% in children aged 2 to 5 years with mild to moderate atopic dermatitis, Arcutis Biotherapeutics announced in a release.1 Based on the positive data, Arcutis said it intends to submit a supplemental new drug application (sNDA) to the FDA during the first quarter of 2025.
Roflumilast Cream Shows Durable Efficacy in Children with Atopic Dermatitis / Марина Терехова - stock.adobe.com
Results from the INTEGUMENT-OLE (NCT04804605) trial showed that roflumilast cream 0.05% met its primary objective of long-term safety. Key secondary endpoints included a Validated Investigator Global Assessment for Atopic Dermatitis vIGA-AD score of 0 or 1, vIGA-AD success defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, and Eczema Area and Severity Index (EASI) score over time.
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“When choosing a therapy for very young children, health care providers and caregivers are looking for treatments that provide both rapid relief and are well-tolerated and suitable for long-term use,” Adelaide Hebert, MD, professor of dermatology and pediatrics at UTHealth Houston, and INTEGUMENT trial investigator, said in a release.1 “These results build upon the findings from the Phase 3 trial of roflumilast cream 0.05% that demonstrated rapid efficacy within the first 4 weeks of treatment, and further showed long-term durable efficacy and tolerability of investigational roflumilast cream, with continued improvement over the course of the long-term study.”
INTEGUMENT-OLE was a multicenter, open-label extension, phase 3 study that evaluated the long-term safety and efficacy of roflumilast cream 0.15% in adults and children aged 6 years and older and roflumilast cream 0.05% in children aged 2 to 5 years. The study cohort included 562 patients with mild to moderate atopic dermatitis who previously completed the INTEGUMENT-PED (NCT04845620) phase 3 trial.
During the study, patients applied either roflumilast cream 0.15% or 0.05% once a day for 52 weeks. Starting at week 4, patients who achieved a vIGA-AD score of 0-Clear switched to twice weekly maintenance treatment and continued as long as their vIGA-AD score did not reach 2-Mild or greater. If patients did reach that score, they could resume daily treatment.
The study found that 53.8% of patients achieved a vIGA-AD score of 0 or 1 plus a 2-grade improvement from baseline at week 56. Efficacy was also seen to improve over time, with 71.9% of patients achieving 75% improvement from baseline in EASI-75 after 56 weeks. Additionally, no new safety signals were observed throughout the study period. Most adverse events were mild to moderate, with the most common being upper respiratory tract infection, nasopharyngitis, pyrexia, influenza, COVID-19, and otitis media.
“Roflumilast cream is uniquely formulated with the AD patient in mind, to deliver treatment without sensitizing excipients and irritants, which can often disrupt the skin barrier. We are excited by these results, which reinforce the strength of our Zoryve product portfolio and specifically demonstrate the long-term efficacy, safety and tolerability profile of our once-daily roflumilast cream for the treatment of pediatric atopic dermatitis,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a release.1 “Based on these positive results, we are convinced that, if approved, roflumilast cream 0.05% can help provide immediate as well as long-term management of this burdensome skin condition, expanding the treatment population to children down to age 2.”
Roflumilast cream 0.3% is currently indicated for the treatment of plaque psoriasis in adult and pediatric patients aged 6 years and older. Roflumilast cream 0.15% is currently indicated for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients aged 6 years and older.
READ MORE: Dermatology Resource Center
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