Long-term nemolizumab therapy in patients with AD and moderate-to-severe pruritus significantly improves pruritus, AD, and quality of life.
Pruritus is a distinguishing symptom of atopic dermatitis (AD), an inflammatory skin disorder that affects up to 25 percent of children and 5 percent of adults globally. The exact cause of pruritus in AD is unknown, but cytokines appear to play a role in the pathophysiology. Interleukin (IL)-31 is a major mediator for pruritus in AD and prurigo nodularis, with pro-inflammatory, immunomodulatory, and pruritogenic actions. Interleukin (IL)-31 influences the inflammatory response, is implicated in the breakdown of the epidermal barrier in atopic dermatitis (AD) and has a important role in pruritus.
The humanized monoclonal antibody nemolizumab targets IL-31 receptor A. The goal of this study, published in the British Journal of Dermatology, was to find out how safe and effective nemolizumab is over the long term for people with AD who have moderate-to-severe pruritus that is not well controlled.
The study comprised two separate long-term phase III longitudinal studies. Patients in study JP01 received nemolizumab or placebo for 16 weeks, followed by a 52-week extension period in which all patients received nemolizumab (nemolizumab/nemolizumab and placebo/nemolizumab groups). Patients in study JP02 received nemolizumab for 52 weeks. Both investigations had a follow-up period of eight weeks. The JP01 nemolizumab/nemolizumab, placebo/nemolizumab; and JP02 nemolizumab groups included 143, 72, and 88 patients, respectively,
Ultimately, it was observed that in the nemolizumab/nemolizumab group, there were clinically significant improvements in the pruritus visual analog scale (66%) and Eczema Area and Severity Index (78%) from the beginning of treatment to week 68. After the first dosage of nemolizumab, quality of life (QoL) markers improved, and these improvements were maintained during the follow-up period. The long-term safety profile was similar to prior studies, and there were no unanticipated late-onset adverse events.
The authors concluded that the long-term use of nemolizumab 60 mg with concurrent topical corticosteroids/topical calcineurin inhibitors in patients with AD and moderate-to-severe pruritus led to a steady improvement in pruritus, signs of AD, and quality of life (QoL) for patients, with a favorable long-term safety profile. These positive and long-lasting benefits, which persisted for 12 weeks after the last treatment, were probably brought on by interrupting the itch–scratch cycle.
Kabashima, K., Matsumura, T., Komazaki, H., & Kawashima, M. (2022). Nemolizumab plus topical agents in patients with atopic dermatitis (AD) and moderate-to-severe pruritus provide improvement in pruritus and signs of AD for up to 68 weeks: results from two phase III, long-term studies. British Journal of Dermatology, 186(4), 642-651. doi:10.1111/bjd.20873