TOPLINE:

In an extension study of children aged 2-5 years with mild-to-moderate atopic dermatitis (AD), roflumilast cream 0.05%, approved in this age group in 2025, was well-tolerated and associated with sustained clinical improvements for up to 56 weeks.

METHODOLOGY:

• A phase 3 open-label extension INTEGUMENT-OLE trial enrolled 562 children aged 2-5 years with mild-to-moderate AD who had completed the 4-week INTEGUMENT-PED study and received roflumilast cream 0.05% (n = 382) or vehicle cream (n = 180).
• Caregivers applied roflumilast once daily to the affected areas at approximately 2 mg/cm² during the 4-week parent trial and continued the same in the INTEGUMENT-OLE trial for up to 52 weeks, with no limit to body surface area for application. Patients who turned 6 years during the study switched to roflumilast cream 0.15% (approved for those aged 6 years or older) at their next scheduled visit; 55 patients received at least one application of the higher concentration.
• Patients who achieved clear skin (Validated Investigator Global Assessment for AD [vIGA-AD] score of 0) at or after week 4 of the open-label extension period switched to twice-weekly application on two nonconsecutive days per week.
• The primary objective was long-term safety, including treatment-emergent adverse events (AEs) and application-site tolerability. Secondary endpoints included vIGA-AD success (clear/almost clear plus ≥ 2-point improvement from parent-study baseline), vIGA-AD 0/1, ≥ 75% improvement in the Eczema Area and Severity Index (EASI-75), and Worst Itch-Numeric Rating Scale (WI-NRS) success (≥ 4-point improvement in patients with baseline score ≥ 4).

TAKEAWAY:

• Overall, treatment-emergent AEs occurred in 49.8% of patients; most were mild (24.7%) or moderate (22.2%); treatment-related AEs occurred in only 2.5% of patients with no serious events reported.
• At week 56, 53.8% of patients who continued roflumilast and 55.0% who switched from the vehicle achieved vIGA-AD success (vIGA-AD 0/1 showed similar trends), and EASI-75 was achieved by 71.9% and 76.0%, respectively. Of 170 patients (30.2%) who achieved clear skin and switched to twice weekly application, the median duration of disease control was 238 days.
• Among patients with a baseline WI-NRS score ≥ 4, WI-NRS success was achieved in 57.9% of those who continued roflumilast and 66.3% of those who switched from vehicle, whereas WI-NRS 0/1 was achieved by 40.5% and 41.1% of patients, respectively.
• Roflumilast cream was well tolerated: investigators reported no application-site irritation in ≥ 97% of patients across visits. Only 0.3% of patients reported a severe hot, tingling/stinging sensation that caused definite discomfort.

IN PRACTICE:

“Among patients who achieved clear skin, clear/almost clear skin and adequate disease control (including pruritus) were maintained for approximately 8 months with proactive BIW [twice-weekly] application,” the authors wrote, noting that “these results are consistent with long-term results observed in patients aged ≥ 6 years and suggest that once-daily and proactive BIW application with roflumilast cream 0.05% can improve and maintain AD signs/symptoms.”

SOURCE:

This study was led by Lawrence F. Eichenfield, Rady Children’s Hospital-San Diego, San Diego, and Departments of Dermatology and Pediatrics, University of California, San Diego, and was published online on March 8 in Pediatric Dermatology.

LIMITATIONS:

This study lacked a long-term vehicle comparator and excluded the assessment or treatment of AD on the scalp, palms, and soles, which limited the generalizability of the results.

DISCLOSURES:

This study was funded by Arcutis Biotherapeutics Inc. Eichenfield and several authors disclosed serving as advisor, consultant, investigator, speaker, and member of board of directors for multiple pharmaceutical companies including Arcutis. Six authors are employees of Arcutis. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.