Results of Extension Study Show Roflumilast Suitable for Children Aged 2 to 5 Years

In July 2024, the FDA approved the supplemental new drug application for roflumilast cream 0.15% for patients 6 years and older.

The results of the INTEGUMENT-OLE (NCT04804605) long-term, open-label study demonstrated that once daily roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics Inc) had durable and favorable safety for children aged 2 to 5 years with mild to moderate atopic dermatitis (AD). Roflumilast was well-tolerated with no new safety signals for up to 56 weeks.¹

Image Credit: Марина Терехова- stock.adobe.com

“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,” said Adelaide Hebert, MD, professor of dermatology and pediatrics at UTHealth Houston, in a news release. “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.”¹

Investigators reported that efficacy was maintained over time for 71.9% of patients who joined the INTGUMENT-PED (NCT04845620) study and achieved 75% improvement from baseline in Eczema Area and Severity Index (EASI) after 56 weeks.¹

About The Trial

Trial Name: Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-OLE)

ClinicalTrials.gov ID: NCT04804605

Sponsor: Arcutis Biotherapeutics Inc

Completion Date: May 2025

Individuals included in the extension study were 2 years or older, had AD that met eligibility criteria, and successfully completed 1 of the 3 preceding studies through week 4. Patients were excluded if they experienced a treatment-related adverse event (AE) or serious AE in a previous study or had another skin condition other than AD, according to the clinical trial information. The primary end point included the long-term safety of the drug over the 52-week study. Secondary end points included the validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment, vIGA-AD success, Worst Itch Numeric Rating Scale score over time, and EASI score over time.²

There were 658 individuals included in the open label study. At any time after week 4, individuals who achieved a clear score with the once daily application switched to twice weekly application.³

Investigators found that 53.6% individuals that rolled over from the INTEGUMENT-PED score achieved vIGA-AD success at 56 weeks. For safety and tolerability, there were no new safety signals identified. The overall incidence of AEs was low, with the majority being mild to moderate in nature. The most frequently reported AEs included upper respiratory tract infection, nasopharyngitis, pyrexia, influenza, COVID-19, and otitis media. Approximately 3% of individuals discontinued the treatment due to AEs.¹

The company plans to submit a supplemental new drug application to the FDA in the first quarter of 2025 for individuals aged 2 to 5 years. In July 2024, the FDA approved the supplemental new drug application for roflumilast cream 0.15% for patients 6 years and older, which was approved as a once daily and steroid-free cream for rapid disease clearance and reduction in itch for long-term disease control.^1,3

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. News release. Arcutis Biotherapeutics Inc. August 28, 2024. Accessed August 28, 2024. Email.

2. Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-OLE). ClinicalTrials.gov identification: NCT04804605. Updated June 04, 2024. Accessed August 28, 2024. https://clinicaltrials.gov/study/NCT04804605

3. Gallagher A. FDA Approves Roflumilast for Atopic Dermatitis in Patients 6 Years and Older. Pharmacy Times. July 10, 2024. August 28, 2024. https://www.pharmacytimes.com/view/fda-approves-roflumilast-for-atopic-dermatitis-in-patients-6-years-and-older