Nemolizumab in Moderate-to-Severe Atopic Dermatitis: Long-Term Safety and Efficacy and New Biomarker Insights

Nemolizumab is an anti-IL-31Rα monoclonal antibody that has demonstrated clinical efficacy in two global Phase III studies (ARCADIA-1 and ARCADIA-2) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This article summarises selected data from oral presentations on nemolizumab at the European Academy of Dermatology and Venereology (EADV) Annual Meeting held in September 2024 in Amsterdam, the Netherlands. Data from interim analyses were presented from the ARCADIA open-label extension study that evaluated the long-term safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe AD. These first long-term data on nemolizumab treatment showed continuous improvement up to 56 weeks in key signs and symptoms of AD, as well as patient-reported quality of life (QoL) measures. Safety findings were consistent with those previously reported, further supporting the long-term use of nemolizumab. Maintaining long-term efficacy and safety over extended periods of treatment is crucial in the management of chronic skin diseases, such as AD, which impose a substantial patient burden. The second presentation demonstrated how clinical improvements in signs and symptoms of AD with nemolizumab treatment correlate with a notable impact on pruritus and hyperplasia/fibrosis biomarkers in the skin. Tape-strips transcriptomic analysis was used to evaluate the effect of nemolizumab on gene expression in a subset of patients with AD from the ARCADIA 1 and 2 studies. Results showed that nemolizumab robustly modulates gene expression, acting on biomarkers related to the three key pillars of AD pathogenesis: pruritus, inflammation, and skin barrier dysfunction. Importantly, patients with severe pruritus at baseline showed stronger downregulation of inflammatory markers, including Type 2, Type 17, and Type 1 biomarkers, highlighting nemolizumab’s therapeutic potential in patients with AD extensively affected by itch.