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:

• FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and up
• Roflumilast foam 0.3% sNDA submitted to treat scalp and body psoriasis in patients 12 years and up
• Roflumilast foam, 0.3% effective in seb patients with intolerance to steroids

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References:

1. 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/
2. 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
3. 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