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. While these findings are promising, the small number of included studies and potential for publication bias warrant cautious interpretation and highlight the need for further research. These findings support its role as a promising option for individuals with PN who are unresponsive to standard therapies.