Nemolizumab shows encouraging results in young children with AD

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.