Nemolizumab for the treatment of atopic dermatitis

Abstract

Purpose: Atopic dermatitis (AD) is a common, heterogeneous inflammatory skin disease characterized by chronic or relapsing eczematous lesions and intense pruritus, leading to reduced quality of life and increased mental health burden. Despite recent therapeutic advances, moderate-to-severe AD remains challenging to manage, and conventional treatments often have limited long-term efficacy and safety concerns. Interleukin-31 (IL-31) is a key mediator in AD pathogenesis, driving pruritus, barrier dysfunction, type 2 inflammation, and fibrosis. Nemolizumab, a humanized monoclonal antibody targeting the IL-31 receptor α-chain (IL-31RA), has emerged as a novel therapeutic option. Materials and methods: This narrative review discusses current understanding of the role of IL-31 in AD pathophysiology. It also summarizes the most recent and relevant clinical trial data on the efficacy and safety of nemolizumab. Results: Multiple phase II and III randomized clinical trials have demonstrated nemolizumab efficacy in patients with moderate-to-severe AD, with significant and sustained reductions in pruritus and overall disease severity. Furthermore, nemolizumab has shown a favorable safety profile, with most adverse events reported as mild and non-serious. Conclusions: IL-31 plays a critical role in the pathogenesis of atopic dermatitis. Findings from clinical trials support the efficacy and safety of nemolizumab in the treatment of moderate-to-severe AD.