Key highlights in this article:
- Long-Term Efficacy: Roflumilast cream 0.05% maintained and increased efficacy over 56 weeks in treating mild to moderate atopic dermatitis in children aged 2 to 5 years.
- Safety Profile: The study found no new safety signals, supporting the long-term safety and tolerability of roflumilast cream for pediatric use.
- Future FDA Submission: Arcutis Biotherapeutics plans to submit a supplemental New Drug Application to the FDA in early 2025 for expanded use in younger children.
Roflumilast cream 0.05% demonstrated efficacy and safety, with no new safety signals in up to 56 weeks of treatment in children aged 2 to 5 years with mild to moderate atopic dermatitis (AD) according to new, long-term phase 3 data from the INTEGUMENT-OLE study (NCT04804605). The results, announced in a press release from Arcutis Biotherapeutics, stated that the topical phosphodiesterase-4 (PDE4) inhibitor maintained and increased efficacy over time.1,2
The INTEGUMENT-OLE study, a phase 3, multicenter, open-label extension study evaluating long-term safety of roflumilast cream 0.05% in children aged 2 to 5 years enrolled 562 individuals after completing the INTEGUMENT-PED phase 3 trial (NCT04845620).3
In the extension study, 71.9% of participants who rolled over from the roflumilast treatment arm in INTEGUMENT-PED achieved a 75% improvement from baseline Eczema Area and Severity Index (EASI-75) after 56 weeks.1
In addition, 53.8% of participants who rolled over achieved a validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at 56 weeks, according to Arcutis.1
"We are excited by these results, which reinforce the strength of our [roflumilast cream] product portfolio and specifically demonstrate the long-term efficacy, safety and tolerability profile of our once-daily roflumilast cream for the treatment of pediatric AD," stated Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis, in a press 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," said Burnett.1
According to the press release, Arcutis plans to submit an supplemental New Drug Application to the FDA in the first quarter of 2025 for roflumilast cream 0.05%. Roflumilast cream 0.15% is FDA approved for the topical treatment of mild to moderate AD in adults and pediatric patients down to 6 years of age.1
The extension study evaluated monotherapy with roflumilast cream 0.05% with no rescue treatment permitted. If participants achieved vIGA-AD of clear, they switched to twice-weekly maintenance treatment and continued this dosing so long as either clear or almost clear was maintained. Once-daily dosing was resumed if vIGA-AD reached 2 or greater mild, and "could also resume once-daily dosing if signs/symptoms of AD were not adequately controlled with maintenance therapy,' stated Arcutis.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," said Adelaide Hebert, MD, professor of dermatology and pediatrics at UTHealth Houston, and INTEGUMENT trial investigator, in a statement.1
Additional roflumilast cream coverage on Contemporary Pediatrics:
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References:
- Arcutis announces positive long-term results of roflumilast cream 0.05% show durable and improved efficacy over time and favorable safety profile in treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. Arcutis Biotherapeutics. https://www.arcutis.com/arcutis-announces-positive-long-term-results-of-roflumilast-cream-0-05-show-durable-and-improved-efficacy-over-time-and-favorable-safety-profile-in-treatment-of-children-aged-2-to-5-with-mild-to-moder/
- Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-OLE). ClinicalTrials.gov. Updated June 4, 2024. Accessed August 28, 2024. https://clinicaltrials.gov/study/NCT04804605
- Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED). ClinicalTrials.gov. Updated May 6, 2024. Accessed August 28, 2024. https://clinicaltrials.gov/study/NCT04845620
