Effectiveness and Safety of Nemolizumab in Patients with Prurigo Nodularis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Prurigo nodularis (PN) is a chronic, severely pruritic condition that markedly impairs quality of life. Existing treatments show limited efficacy, prompting investigation of nemolizumab, an IL-31 receptor antagonist. This meta-analysis evaluated randomized controlled trials (RCTs) comparing nemolizumab with placebo in patients with PN. Effectiveness endpoints included a ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale (PP-NRS4), a ≥ 2-point reduction in the Investigator's Global Assessment (IGA), and a ≥ 4-point improvement in the Sleep Disturbance Numerical Rating Scale (SD-NRS). Three RCTs involving 497 patients met the inclusion criteria. Pooled analyses showed nemolizumab significantly increased the likelihood of achieving PP-NRS4 response (OR = 6.92, 95% CI: 3.84–12.45, P < .00001), IGA reduction (OR = 7.59, 95% CI: 3.58–16.12, P < .00001), and SD-NRS improvement (OR = 3.99, 95% CI: 2.39–6.66, P < .00001). Safety outcomes did not differ significantly between nemolizumab and placebo for adverse events, serious adverse events, or other specific categories. In conclusion, while maintaining a favorable safety profile, nemolizumab demonstrates robust efficacy in reducing pruritus, lesion severity, and sleep disturbance in patients with PN. These findings support its role as a promising option for individuals with PN who are unresponsive to standard therapies.