Summary of New Findings
- Arcutis Biotherapeutics successfully met primary and secondary endpoints in the INTEGUMENT-PED phase 3 study of roflumilast cream 0.05% for mild-to-moderate AD in patients aged 2 to 5 years.
- The study involved 652 children, and defined the primary endpoint as achieving IGA Success, which required a 'clear' or 'almost clear' rating along with a 2-grade improvement from baseline at 4 weeks.
- Showed that 25.4% of children treated with roflumilast cream 0.05% reached IGA Success at 4 weeks, compared to 10.7% in the vehicle-treated group, with noticeable improvements in first week.
- Roflumilast cream 0.05% also showed substantial secondary endpoint improvements, including a 39.4% reduction in the EASI-75 and a 35.3% reduction in the Worst Itch Numeric Scale (WI-NRS) at 4 weeks, consistent with previous pivotal trials in pediatric and adult atopic dermatitis patients.