What Is New in Paediatric Dermatology

Children receiving weight-based nemolizumab achieved rapid improvements in eczema severity and itch. The safety assessment revealed no new safety signals.

The interleukin-31 receptor (IL-31RA) alpha antagonist nemolizumab was evaluated in a 52-week phase 2 study (NCT04921345) that included 109 children aged 2–11 years with moderate-to-severe atopic dermatitis (AD). The open-label trial comprised 3 consecutively enrolled cohorts. Primary outcomes focused on pharmacokinetics, including serum concentrations, clearance, and half-life, as well as safety; efficacy endpoints were also assessed [1].

Results from the first cohort (n=36) indicated pharmacokinetic differences relative to previous studies in adolescents and adults, prompting dose adjustments in the subsequent 2 cohorts. These cohorts were stratified by age (2–6 and 7–11 years) and received weight-based subcutaneous nemolizumab every 4 weeks for 52 weeks: 5 mg for children weighing 10 to <20 kg, 10 mg for 20 to <30 kg, and 15 mg for ≥30 kg. Concomitant use of topical corticosteroids and emollients was permitted.

At week 16, Investigator’s Global Assessment (IGA) scores of clear or almost clear (0/1) were achieved by 41% of children aged 7–11 years and 47% of those aged 2–6 years. Eczema Area and Severity Index (EASI): 75 responses were observed as early as week 4, reaching 73% and 69% at week 16, respectively. A clinically meaningful reduction in itch (≥4-point improvement on the Peak Pruritus Numerical Rating Scale [PP-NRS]) was reported by 59% of children aged 7–11 years and 72% of those aged 2–6 years at the same time point. Overall, treatment responses were sustained through week 52.

Safety findings were consistent with previous studies, with no new signals in this paediatric population. No serious adverse events were reported; however, 1 severe case of eosinophilia and 1 case of AD exacerbation occurred, both of which resolved.

Eichenfield LF, et al. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. S023 Late-Breaking Research: Session 1. AAD 2026, 27–31 March, Denver, CO, USA.

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.

Nemolizumab shows encouraging results in young children with AD

Roflumilast cream demonstrates clinical benefit in infants with AD