Arcutis Announces Positive Phase 3 Data on Roflumilast Cream 0.05% for Atopic Dermatitis in Young Children

Once-daily roflumilast cream 0.05% (Zoryve) led to rapid and significant improvement in children aged 2 to 5 years with mild to moderate atopic dermatitis (AD), according to new phase 3 study results published online in Pediatric Dermatology.¹

The INTEGUMENT-PED study results, announced by Arcutis Biotherapeutics, Inc., mark a notable advance in steroid-free topical options for pediatric AD, which affects approximately 1.8 million children in the United States. A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration (FDA) for this lower-concentration formulation.

Study authors reported that roflumilast cream 0.05% significantly reduced AD severity as early as Week 1, with a notable effect on pruritus seen in as little as 24 hours.²

“AD is a chronic, inflammatory skin disease affecting 1.8 million children ages 2 to 5 in the United States with burdensome symptoms that often result in impaired quality of life for both patients and their caregivers,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and lead author on the publication. “Results from the INTEGUMENT-PED trial demonstrate that Zoryve cream 0.05% can quickly and reliably improve the symptoms of AD, especially itch. The publication of these results and the entire clinical development program highlight that Zoryve cream 0.05%, if approved, could fill a significant gap in the current treatment landscape for a once-daily steroid-free topical therapy that is appropriate for both the short and long-term management of AD, key concerns for young patients and their caregivers.”²

INTEGUMENT-PED was a randomized, double-blind, vehicle-controlled phase 3 trial evaluating once-daily roflumilast cream 0.05% in children aged 2 to 5 years with mild to moderate AD. A total of 652 participants with a mean body surface area involvement of 22% (range, 3%-82%) received either active treatment or vehicle for 4 weeks. The data expand on prior findings from studies of roflumilast cream 0.15% in patients aged 6 years and older.

Some of the key findings from the study include:

• Primary Endpoint (vIGA-AD Success): At Week 4, 25.4% of children receiving roflumilast cream 0.05% achieved validated Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) Success vs 10.7% on vehicle (P < .0001).
• EASI-75: A total of 39.4% of children treated with roflumilast cream reached a 75% improvement in Eczema Area and Severity Index, compared with 20.6% on vehicle (P < .0001).
• Itch Reduction: Improvement in itch was observed as early as 24 hours. At Week 4, 35.3% of children in the roflumilast group achieved ≥4-point reduction on the Worst Itch Numeric Rating Scale vs 18% on vehicle (nominal P = .0002).
• Safety and Tolerability: Treatment-emergent adverse events (TEAEs) were low and generally similar across active and vehicle arms. The most frequent events included upper respiratory tract infection, diarrhea, and vomiting (all <4.1%).¹

A decision on the sNDA is anticipated later this year.

“On the heels of our recent submission of an sNDA to the FDA for Zoryve cream 0.05%, we’re proud to share the full INTEGUMENT-PED results published in Pediatric Dermatology with the dermatology community, supporting the well-established efficacy, safety, and tolerability profile of this lower concentration of Zoryve cream,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “We’re committed to bringing forth meaningful innovation and addressing the significant unmet need for topical treatments of young children living with the challenges of AD. We look forward to the FDA’s potential approval of Zoryve cream 0.05% anticipated later this year.”²

Roflumilast cream is a topical phosphodiesterase-4 (PDE4) inhibitor. PDE4 blockade decreases the production of proinflammatory mediators and increases anti-inflammatory mediators. Higher concentrations of roflumilast cream (0.3% and 0.15%) are already FDA-approved for use in plaque psoriasis and mild to moderate AD in patients ≥6 years of age. The 0.05% formulation remains investigational for younger pediatric populations pending regulatory review.²

Roflumilast 0.15% was approved as Zoryve for treatment of AD in people aged 6 Years and older in July 2024.

References

1. Eichenfield LF, Kircik LH, Epps RE, et al. Roflumilast cream 0.05% once daily in children 2 to 5 years with mild to moderate atopic dermatitis (INTEGUMENT-PED): a phase 3 randomized, double-blind, vehicle-controlled trial.
Pediatr Dermatol. doi:10.1111/pde.15840. Published online February 2025. Accessed February 24, 2025.
https://onlinelibrary.wiley.com/doi/full/10.1111/pde.15840?campaign=wolearlyview

2. Arcutis Announces Publication of Positive Data From INTEGUMENT-PED Trial Evaluating ZORYVE (Roflumilast) Cream 0.05% in Children 2 to 5 Years Old With Mild to Moderate Atopic Dermatitis in Pediatric Dermatology [news release]. Published February 24, 2025. Accessed February 24, 2025.
https://www.arcutis.com/arcutis-announces-publication-of-positive-data-from-integument-ped-trial-evaluating-zoryve-roflumilast-cream-0-05-in-children-2-to-5-years-old-with-mild-to-moderate-atopic-dermatitis-in-pediat/