Roflumilast cream demonstrates clinical benefit in infants with AD

Infants treated with topical roflumilast experienced meaningful improvements across multiple efficacy endpoints. The treatment was well tolerated and associated with a low discontinuation rate.

The phase 2 open-label INTEGUMENT-INFANT study (NCT06998056) evaluated once-daily roflumilast cream 0.05% in 101 paediatric patients aged 3 months to <24 months with atopic dermatitis (AD) [1]. Prof. Lawrence Eichenfield (UC San Diego School of Medicine, CA, USA) presented safety and efficacy data of the phosphodiesterase-4 (PDE-4) inhibitor roflumilast over 4 weeks in infants with moderate-to-severe AD.

Efficacy analyses in the 96 infants who completed the study showed that 34.4% achieved a ≥2-point improvement and reached clear or almost clear skin on the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) at week 4. Overall, 49% of patients achieved a vIGA-AD score of 0/1. Notably, approximately one-quarter of patients responded as early as week 2. Eczema Area and Severity Index (EASI) 75 responses were observed in 34% of patients at week 2 and increased to 58.3% by week 4.

Clinically meaningful responses were also observed in difficult-to-treat areas. Among infants with at least mild scalp involvement at baseline, 67.5% achieved clear or almost clear scalp skin at week 4.

Improvements in pruritus were rapid and substantial. By week 2, 60.3% of caregivers reported a ≥4-point reduction on the Worst Scratch Itch Numeric Rating Scale, increasing to 72.4% at week 4. Improvements measured by the Dynamic Pruritus Scale-25 were observed in nearly half of the infants within 10 minutes of application and in 66.7% at 4 hours.

Treatment-emergent adverse events were reported in 43.6% of patients, with nearly 36% classified as mild and none as severe. Adverse events (AEs) leading to discontinuation occurred in 1 patient, and no serious AEs were observed. The most common AEs (≥3%) were diarrhoea, nasopharyngitis, vomiting, and upper respiratory infections. Application-site irritation was reported in just over 2% of patients.

Based on these findings, roflumilast cream may represent a promising non-steroidal treatment option in the currently limited armamentarium for infants with AD.

Eichenfield LF, et al. INTEGUMENT-INFANT: Once-daily roflumilast cream 0.05% in infants aged 3–<24 months with atopic dermatitis. S023 Late-Breaking Research: Session 1. AAD 2026, 27–31 March, Denver, CO, USA.