RAD 2025: Roflumilast cream significantly improved atopic dermatitis in children and adolescents through 52 weeks, offering a safe, effective treatment option.
Long-term results from the INTEGUMENT-OLE study demonstrate sustained improvements in signs, symptoms, and quality of life in participants aged ≥2 years with atopic dermatitis (AD) treated with once-daily or twice-weekly roflumilast (Zoryve) cream, according to data presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville.
The phase 3, multicenter, open-label extension (OLE) enrolled 1220 participants from prior pivotal INTEGUMENT trials: 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.
At week 56, Investigator Global Assessment for AD (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.
Participants who achieved vIGA-AD 0 could transition from once-daily to proactive twice-weekly (BIW) application. Disease control, defined as the duration of vIGA-AD 0/1 with adequate symptom management, was sustained with a median Kaplan-Meier estimated duration of 281 days (95% CI, 147–not estimable) in participants aged ≥6 years and 238 days (95% CI, 146–331) in those aged 2–5 years.
Researchers also reported that roflumilast cream was well tolerated across age groups. Treatment-related adverse events occurred in 4.7% of participants from INTEGUMENT-1/2 and 2.5% of those from INTEGUMENT-PED. Application-site pain was infrequent, reported in only 0.5% and 0.7% of participants, respectively. No new safety signals emerged during the long-term treatment period.
“These data support the long-term use of roflumilast cream as a safe and effective steroid-sparing topical for managing pediatric and adolescent AD,” the authors concluded. Notably, proactive BIW application was effective in maintaining remission following disease clearance.
Roflumilast cream 0.15% is currently approved in the US for the treatment of mild-to-moderate AD in people aged ≥6 years. The INTEGUMENT-OLE study further supports its potential as a long-term maintenance therapy in younger populations.
Source: Chih-ho Hong H, Simpson E, Eichenfield LF, et al. Improvement in atopic dermatitis signs and symptoms with once-daily and proactive twice-weekly roflumilast cream 0.15% or 0.05%: Results from the 52-week phase 3 INTEGUMENT-OLE trial in patients aged ≥2 years. Poster presented at Revolutionizing Atopic Dermatitis; June 6-7, 2025; Nashville, TN.
Lebrikizumab Demonstrates Efficacy, Safety in Patients With Skin of Color With AD
June 11th 2025RAD 2025. Lebrikizumab improved skin clearance, itch, and pigmentation in patients with skin of color and atopic dermatitis, with strong safety data through 24 weeks, according to late-breaking data.