33317 Study of nemolizumab pharmacokinetics, safety, and efficacy in adolescents with atopic dermatitis

Abstract

Background: Atopic dermatitis (AD) is common in children, including moderate to severe disease (MTS). Nemolizumab, an interleukin 31 receptor-α (IL31RA) inhibitor, has safety and efficacy in adults with AD. The objective of this study was to evaluate nemolizumab in adolescents. Methods: Open-label 16-week study of nemolizumab in patients aged 12-17 years with MTS AD and associated pruritus with baseline average daily itch-NRS intensity of at least 4. Nemolizumab was administered subcutaneously as a loading dose of 60 mg at baseline, followed by 30 mg every 4 weeks until week 12 with background topical corticosteroid or calcineurin inhibitor treatment. Standard pharmacokinetic (PK), efficacy, and safety assessments performed. Results: 20 patients participated (8M/12F), with a mean age of 14.8 ± 1/6 years. Baseline (BL) mean Eczema Area and Severity Index (EASI) score was 25.2 ± 7.22. Concentrations peaked 1-2 weeks after loading dose, and steady state occurred by week 4. Nemolizumab PK showed linear elimination, a first order absorption, and a mean half-life of 16.7 ± 4.12 days. In population PK analysis, exposures in adolescents were comparable to adults. The main source of PK variability was body weight. There were marked improvements in key AD signs/symptoms (mean EASI decreased 66.5%, itch NRS decreased 43.2%, sleep NRS decreased 53.5%). Adverse events were experienced by 33.3% of subjects (n = 6) and were primarily mild or moderate in severity. Conclusion: Nemolizumab’s PK, safety and efficacy profile was consistent in adolescents and adults patients with MtS AD.