Arcutis Presents New ZORYVE Data in AD at Fall Clinical 2025
Key Takeaways
ZORYVE cream 0.15% and 0.05% significantly reduced sleep disturbances and itch in children and adults with atopic dermatitis.
Twice-weekly ZORYVE maintained disease control for a median of 238 to 281 days following initial daily treatment.
Researchers reported low rates of treatment-related and application-site adverse events over 56 weeks.
Updates and new data sets from the INTEGUMENT trial program, including new quality-of-life and efficacy data for ZORYVE® (roflumilast) cream in pediatric and adult patients with atopic dermatitis (AD), were featured at the 2025 Fall Clinical Dermatology Conference in Las Vegas, according to a release from manufacturer Arcutis Biotherapeutics.
INTEGUMENT PIVOTAL TRIALS
According to the new data, ZORYVE cream 0.15% and 0.05% significantly reduced itch and sleep disturbances in individuals aged ≥2 years compared to vehicle. In children aged 2 to 5 years, caregiver-reported outcomes confirmed reduced impact on sleep. Mean reductions in itch, measured by the Worst Itch Numeric Rating Scale (WI-NRS), were greater with ZORYVE than vehicle at week 4 (2.6 vs 1.6; P < 0.001 for INTEGUMENT-1/2; P < 0.01 for INTEGUMENT-PED). Improvements were observed within 24 hours of the first application (P < 0.005). The researchers reported no new safety signals.
“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, lead author and INTEGUMENT-PED investigator, in a press release from Arcutis. “ZORYVE offers a safe, nonsteroidal, and targeted treatment option. These results highlight the clinically meaningful benefit of ZORYVE cream on reducing itch and improving sleep.”
INTEGUMENT-OLE
For the 52-week open-label extension INTEGUMENT-OLE study, long-term treatment with ZORYVE was associated with sustained efficacy and durable disease control in participants aged ≥2 years, according to the press release. In those individuals rolled over from the pivotal studies (n = 1,220), participants who had achieved clear skin (vIGA-AD 0) by week 4 were swtiched to a proactive twice-weekly maintenance regimen. Median disease control duration following transition was 238 days in children aged 2 to 5 and 281 days in those aged 6 years or older.
ZORYVE continued to show benefit over 56 weeks. Among participants, 55.7% (INTEGUMENT-1/2) and 63.1% (INTEGUMENT-PED) achieved vIGA-AD 0/1 at week 56. No/minimal itch was reported by 41.4% and 40.7% of participants at week 56, respectively. Treatment-related adverse events were reported in 2.5% (INTEGUMENT-PED) and 4.7% (INTEGUMENT-1/2) of participants.
“These findings reinforce ZORYVE as an advanced targeted topical treatment and a meaningful alternative to topical corticosteroids—providing effective, well-tolerated therapy for individuals living with atopic dermatitis in need of long-term disease control,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis Biotherapeutics, in a press release.
Source: Arcutis news release. October 24, 2025.