New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

New long-term data suggest once-daily roflumilast cream .05% (ZORYVE) can allow for sustained symptom control and a favorable safety profile among children aged 2 - 5 years with mild-to-moderate atopic dermatitis.1

These data were announced by Arcutis Biotherapeutics, Inc., resulting from the phase 3 open-label extension INTEGUMENT-OLE trial looking at the use of once-daily roflumilast cream .05%, a topical phosphodiesterase-4 inhibitor, in young children living with atopic dermatitis. Atopic dermatitis, the most prevalent form of eczema, is estimated to impact roughly 9.6 million children across the US.

“In my clinical practice, young children with atopic dermatitis struggle with the itchy rash that can cover large portions of their bodies,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and lead author of this publication, said in a statement.1

This recent extension study built upon earlier data resulting from the 4-week phase 3 INTEGUMENT‑PED trial, which initially established the safety and efficacy of roflumilast cream .05% in children between 2 and 5 years of age. Data from the INTEGUMENT-OLE study supported the US Food and Drug Administration (FDA) approval of roflumilast cream .05% in October 2025 for this age cohort.2 Over as long as 56 weeks of use, the treatment demonstrated a favorable safety profile and was generally shown to be well-tolerated. Those evaluating the drug had also reported that clinical benefits persisted throughout the study and continued to improve over time.

In the latest open-label safety extension, children were recruited had previously participated in INTEGUMENT-PED and had been given either roflumilast cream .05% or a vehicle cream during that earlier 4-week analysis.1 During the extension phase, there were 562 participants given roflumilast cream .05% once each day as monotherapy for up to 52 weeks to all areas affected by atopic dermatitis except the scalp. Those involved who attained completely clear skin, defined as a Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) score of 0 at or after Week 4, were transitioned to a proactive twice-weekly maintenance regimen.

Reported efficacy outcomes included results from both individuals who remained on once-daily roflumilast cream and those who moved to the twice-weekly schedule.1 In their assessment of safety, Eichenfield and coauthors found treatment-emergent adverse events (TEAEs) appeared in 49.8% of subjects. Most were classified as mild (24.7%) or moderate (22.2%). The AEs found to have been reported most frequently included upper respiratory tract infection (8.7%), pyrexia (5.0%), and nasopharyngitis (5.0%). Gastrointestinal adverse events occurred in 4.4% of participant.

Serious AEs were documented in 3.2%, though Eichenfield et al determined that none were connected to the treatment.1 Overall, 2.5% of the 562 participants saw treatment-related adverse events, and application-site pain was reported by .7% of these children. Assessments of local tolerability by investigators suggested at least 97% of subjects showed no signs of irritation throughout the study period. In their evaluation of caregiver-reported outcomes, the data suggested minimal discomfort, with burning or stinging sensations rarely seen.

Severe symptoms took place in no more than 1.8% of those treated at any assessment point and were noted among just .3% of children by the 56-week mark. During the analysis, 55 participants reached their sixth birthday and therefore received at least a single application of roflumilast cream .15%. Safety data within this subgroup aligned with those observed in the broader study population.

Secondary endpoints identified in the analysis demonstrated sustained and gradually improving treatment responses.1 Among those who completed the full 56 weeks of treatment, 63.1% attained a vIGA-AD score of clear or almost clear (0 or 1) by the 56-week mark. The investigative team also found 71.9% of children who continued roflumilast therapy and 76.0% of those who switched from vehicle cream to roflumilast attained at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) by the study’s conclusion.

Pruritus improvements were assessed via caregiver reports using the Worst Itch Numeric Rating Scale (WI-NRS).1 By the conclusion of the trial, the team found 57.9% of children who remained on roflumilast and 66.3% of those who transitioned from vehicle treatment reported an improvement of at least 4 points on the scale. Those who saw complete skin clearance following Week 4 transitioned to a twice-weekly proactive treatment schedule. Among the 30.2% of children who entered this maintenance phase, Kaplan-Meier analysis estimated a median duration of disease control of 238 days, defined as maintaining a vIGA-AD rating of clear or almost clear with adequate symptom control while implementing the twice-weekly regimen.

“Providing safe, effective nonsteroidal treatment options for young patients—who can have substantial disease burden but have limited available therapies—remains an important goal in pediatric dermatology,” Eichenfield said in his statement.1 “The publication of these data reinforces [roflumilast] cream 0.05% as a meaningful, long-term treatment option for children living with atopic dermatitis and their families.”

References

1. Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE® (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology. Arcutis Biotherapteutics, Inc. March 10, 2026. https://investors.arcutis.com/news-releases/news-release-details/arcutis-announces-publication-positive-long-term-safety-and-0.

2. Smith T. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed March 10, 2026. https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years.