Long-Term Roflumilast Data Show Durable Efficacy in Young Children and Adults with Atopic Dermatitis
RAD 2025: Arcutis Biotherapeutics will present promising long-term data on roflumilast cream, focused on effectiveness and safety for treating atopic dermatitis in young children.
Arcutis Biotherapeutics will present new long-term data this weekend at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, highlighting durable clinical benefits and favorable tolerability of roflumilast (Zoryve) cream in patients with atopic dermatitis (AD), including children as young as 2 years of age.
Results from the Phase 3 INTEGUMENT-OLE study show that twice-weekly proactive use of investigational roflumilast cream 0.05% maintained disease control in young children with AD for a median of 238 days. These data are consistent with results seen in older children and adults, where the median duration of disease control was 281 days with the same dosing schedule.
Across all age groups, roflumilast cream 0.15% and investigational 0.05% provided sustained improvements in AD signs and symptoms over the course of up to 56 weeks. Among participants aged 6 years and older, the proportion achieving vIGA-AD 0 or 1 rose from 32.7% at Week 4 to 55.7% at Week 52. In children aged 2 to 5 years, that rate increased from 28.8% to 63.1% over the same time frame. Clinically meaningful reductions in itch (≥4-point WI-NRS decrease) were also observed, improving from 30.9% to 55.3% in the older group and from 41.2% to 60.7% in younger children over the treatment period.
Nearly half of all participants achieved no or minimal itch by the end of treatment. WI-NRS scores of 0 or 1 were reached by 47.1% of participants 6 and older, and 40.7% of those aged 2 to 5.
Roflumilast was well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 and older, and 2.5% of those aged 2 to 5. Application-site pain was infrequent, reported by 0.5% and 0.7% of patients, respectively.
The data underscore the potential of roflumilast as a long-term, steroid-free option for children and adults with AD, according to Jonathan Silverberg, MD, PhD, MPH, of The George Washington University. “These findings reinforce the well-established efficacy and safety profile of ZORYVE cream 0.15% and build confidence in the investigational 0.05% formulation, especially for younger children where tolerability and safety are paramount,” he said.
Roflumilast cream 0.15% is currently FDA-approved for mild to moderate AD in patients aged 6 and older. The 0.05% formulation is under FDA review for use in children aged 2 to 5, with a PDUFA target action date of October 13, 2025.
