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Long-Term Safety and Efficacy of Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% for Mild-to-Moderate
Lawrence F Eichenfield1, Mercedes E Gonzalez2, Mark Boguniewicz3
1Rady Children's Hospital-San Diego, Departments of Dermatology and Pediatrics, University of California San Diego-School of Medicine, San Diego, California, USA.
Insights
Roflumilast cream 0.05% showed a good safety profile and lasting effectiveness for up to 56 weeks in young children with atopic dermatitis (AD). Disease control was maintained even with twice-weekly application.
Area of Science:
- Dermatology
- Pediatrics
- Pharmacology
Background:
- A previous trial demonstrated the efficacy and safety of roflumilast cream 0.05% in children aged 2-5 years with mild-to-moderate atopic dermatitis (AD).
- This study investigated the long-term outcomes of continuing roflumilast cream for up to 56 weeks in a phase 3 open-label extension trial (INTEGUMENT-OLE).
Purpose of the Study:
- To evaluate the long-term safety and efficacy of roflumilast cream 0.05% in children with AD.
- To assess the duration of disease control with twice-weekly application in patients who achieved clear or almost clear skin.
Main Methods:
- Patients from the INTEGUMENT-PED trial continued roflumilast cream 0.05% once-daily.
- Patients achieving clear (vIGA-AD 0) at week 4 switched to twice-weekly (BIW) application.
- Safety (adverse events, tolerability) and efficacy (vIGA-AD success, EASI, itch reduction) were assessed up to 56 weeks.
Main Results:
- Roflumilast cream was well-tolerated, with only 2.5% experiencing treatment-related adverse events.
- At 56 weeks, 63.1% of patients achieved clear or almost clear skin (vIGA-AD 0/1).
- For patients switching to BIW application, the median duration of disease control was 238 days.
Conclusions:
- Roflumilast cream 0.05% offers a favorable long-term safety profile and sustained efficacy for up to 56 weeks in young children with AD.
- Disease control can be maintained with twice-weekly application, consistent with previous findings in older children.
Background:
INTEGUMENT-PED/NCT04845620, a 4-week, phase 3 trial, demonstrated efficacy and safety of roflumilast cream 0.05% in children aged 2-5 years with mild-to-moderate atopic dermatitis (AD). A phase 3 open-label extension trial (INTEGUMENT-OLE [NCT04804605]) investigated long-term outcomes continuing roflumilast cream for ≤ 56 weeks.
Methods:
Caregivers of eligible patients from INTEGUMENT-PED applied roflumilast cream 0.05% once-daily in INTEGUMENT-OLE. Patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) clear (0) at/after week 4 of INTEGUMENT-OLE switched to twice-weekly (BIW) application. Evaluation of safety (adverse events [AEs] and application-site tolerability) was the primary objective. Efficacy endpoints assessed from INTEGUMENT-PED baseline included vIGA-AD success (clear/almost clear [0/1] plus ≥ 2-point improvement), vIGA-AD 0/1, ≥ 75% improvement in Eczema Area and Severity Index, and Worst Itch-Numeric Rating Scale success (≥ 4-point improvement in patients with baseline score ≥ 4). Duration of vIGA-AD 0/1 and sign/symptom control ("disease control") with BIW application was determined.
Results:
Among 562 patients, 14 (2.5%) had treatment-related AEs reported. Roflumilast was well tolerated; application-site pain AEs were reported for four (0.7%) patients. At treatment-week 56, AD signs/symptoms continued to improve (63.1% of patients achieved vIGA-AD 0/1). Of 170 (30.2%) patients who switched to BIW application, the median Kaplan-Meier duration of "disease control" was 238 days.
Conclusions:
Roflumilast cream 0.05% demonstrated a favorable long-term safety profile and durable efficacy for up to 56 weeks of treatment in children aged 2-5 years with AD, and "disease control" was maintained with BIW application. These results are consistent with previous studies, including patients aged ≥ 6 years from INTEGUMENT-OLE.
Trial Registration:
Clinicaltrials.gov identifier: NCT04845620.
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