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On June 6, 2025, we reported on findings from an open-label extension (OLE) study of the INTEGUMENT phase 3 clinical trial program presented at the Revolutionizing Atopic Dermatitis (RAD) Conference 2025 in Nashville, TN.
The study
The phase 3 OLE trial investigated the long-term effectiveness and safety of roflumilast cream (0.15% or 0.05%) for the treatment atopic dermatitis (AD) in patients aged ≥2 years. The study included 1220 participants from INTEGUMENT-1/2 (participants aged ≥6 years; n = 658) and INTEGUMENT-PED (participants aged 2–5 years; n = 562). Participants who completed the 4-week parent trials without safety concerns received roflumilast cream 0.15% (≥6 years) or 0.05% (2–5 years) for up to 52 weeks.
After 4 weeks of once-daily application, participants who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) switched to twice-weekly application to normal-appearing flare-prone areas (proactive treatment).
The findings
At week 56, vIGA-AD scores of 0/1 (clear or almost clear) were achieved by 55.7% of participants aged ≥6 years and 63.1% of participants aged 2–5 years. A more than 2-point vIGA-AD improvement from baseline (vIGA-AD success) was achieved in 49.0% and 54.2% of the older and younger groups, respectively.
Improvements in itch, assessed by the Worst Itch Numeric Rating Scale (WI-NRS), were also maintained. Among participants aged ≥6 years with baseline WI-NRS ≥4, 60.7% achieved a ≥4-point improvement by week 56; in those aged 2–5 years, the response rate was 55.3%.
Body surface area (BSA) involvement decreased from baseline in both cohorts. In participants aged ≥6 years, the mean BSA improved from 14.8% at parent study baseline to 3.7% at week 56. In children aged 2–5 years, BSA improved from 22.3% to 4.9% over the same period.
Authors' comments
"These data support the long-term use of roflumilast cream as a safe and effective steroid-sparing topical for managing pediatric and adolescent AD."
