Pharmacological profiles and clinical findings of nemolizumab as treatment for pruritus associated with atopic dermatitis

Abstract

Nemolizumab (Mitchga® syringes) is a biologic with a novel mechanism of action that was first approved in Japan in March 2022 for pruritus associated with atopic dermatitis (AD) only when existing treatments were insufficiently effective. Nemolizumab is a humanized antihuman interleukin-31 (IL-31) receptor A (IL-31RA) monoclonal antibody that targets the receptor for IL-31, the major pruritogen in AD. Nemolizumab inhibits IL-31 signaling and suppresses pruritus by competitively preventing IL-31 from binding to IL-31RA. In the phase III study, nemolizumab, 60 ‍mg, was administered subcutaneously once every 4 weeks, in combination with topical therapy, to patients aged 13 years or older who had AD and inadequately controlled moderate-to-severe pruritus. The efficacy of the treatment was verified by mean percentage change in the pruritus visual analogue scale score from baseline to 16 weeks. Skin symptoms and quality of life (QOL) were improved after 16 weeks. Furthermore, data for up to 68 weeks revealed continuous improvement and/or maintenance of itching, skin symptoms, and QOL. The most common adverse effects were worsening of AD, skin infection, and upper respiratory tract infection. Because skin symptoms may worsen during treatment with this product, patients must be monitored carefully and managed appropriately (e.g., by intensifying treatment with topical anti-inflammatory drugs or withdrawal of medication as needed). Nemolizumab effectively suppresses itching, the most distressing symptom of AD, and improves skin symptoms. It is also expected to help improve QOL, including sleep.This review describes the pharmacological properties of nemolizumab, pharmacokinetics, efficacy and safety in clinical trials in Japan.