New patient- and caregiver-reported outcomes across 3 phase 3 trials demonstrated improved itch and reduced impact of AD on sleep in patients 2 years and older.
tFall Clinical: Roflumilast creams 0.15%, 0.05% reduce sleep disruptions in AD patients 2 years, older | Image Credit: © Gorodenkoff
- © Gorodenkoff - stock.adobe.com.
According to an announcement out of the Fall Clinical Dermatology Conference, roflumilast cream 0.15% and 0.05% (Zoryve; Arcutis Biotherapeutics) reduced sleep disruptions in patients with atopic dermatitis (AD) aged 2 years and older.1
The 0.15% formulation, approved to treat mild-to-moderate AD in patients aged 6 years and older, and the 0.05% formulation, approved for patients aged 2 to 5 years old, improved itch and reduced the negative impact of atopic dermatitis on sleep in these individuals. Data was through 4 weeks of treatment compared to vehicle, based on a trio of phase 3 trials:
While specific data points related to sleep were not included in the announcement, Arcutis stated the creams "reduced the impact of atopic dermatitis on sleep loss/disturbance for study participants and families as compared to vehicle across multiple patient-reported outcome measurements.1 In addition, the reduced impact of atopic dermatitis on sleep for individuals with atopic dermatitis (and their family, in patients aged ≤17 years) was similar among the ≥6-year and 2–5-year-old age groups."
"Sleep disruption is a persistent and often overlooked but very real daily burden for those impacted by atopic dermatitis, including young children and their families,” said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC, INTEGUMENT-PED clinical trial investigator, and lead author of the poster. “ZORYVE offers a safe, nonsteroidal, and targeted treatment option. In addition, these results highlight the clinically meaningful benefit of ZORYVE cream on reducing itch and improving sleep in young children with atopic dermatitis.”
New long-term data from the INTEGUMENT-OLE long-term extension study (NCT04804605) in patients 2 years and older showed that both formulations were well-tolerated, decreased signs and symptoms of atopic dermatitis, and maintained or increased improvements through up to 56 weeks of treatment.
These study participants previously completed INTEGUMENT-1/2.
The 0.05% formulation of roflumilast was approved by the FDA on October 6, 2025, for patients with AD aged 2 to 5 years. The approval was based on results from the phase 3 INTEGUMENT-PED trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study.2
In INTEGUMENT-PED, roflumilast achieved rapid disease clearance, with significant improvement seen as early as week 1. By week 4, 25.4% of children treated with roflumilast reached Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success—defined as “clear” or “almost clear” skin with at least a 2-grade improvement from baseline—compared with 10.7% using vehicle (P < .0001).
Roflumilast also improved itch and overall disease severity, with 39.4% having achieved Eczema Area and Severity Index of 75% or greater improvement (EASI-75) at week 4 compared with 20% with vehicle, with over one-third of caregivers having reported a 4-point or greater reduction in itch scores (vs 18% with vehicle). Adverse events were mostly mild and included upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.
The formulation for the older indication, 0.15%, was approved by the FDA on July 9, 2024, to treat AD in children aged 6 years and older, based on the INTEGUMENT-1/2.3
For this indication, as previously reported by Contemporary Pediatrics, both studies met the primary outcome of IGA success:
In addition, more than 40% of adults and children aged 6 years and older treated with roflumilast cream achieved a 75% reduction according to the Eczema Area and Severity Index (EASI-75) at week 4 (INTEGUMENT-1: 43.2% vs 22% [P< 0.0001]) and (INTEGUMENT-2: 42% vs 19.7% [P< 0.0001]).
“We continue to build upon the body of evidence for ZORYVE cream in atopic dermatitis with these presentations at Fall Clinical, including one of the first analyses to report on improvements in sleep as measured through patient-reported outcome data," added Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis Biotherapeutics. "A separate poster presentation demonstrated that ZORYVE cream decreased signs and symptoms of atopic dermatitis in children aged 2 years and older. Importantly, a decrease in the body surface area affected was maintained or improved over 52 weeks of treatment with ZORYVE cream, which is meaningful improvement in children who often have more widespread disease across their smaller bodies."1
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