Raja Ahsan Raza, Fazal Zoha Zahid, Sethi Aisha
Medical College, Aga Khan University, Karachi, Pakistan.
Stanford University School of Medicine, Palo Alto, CA, USA.
Clin Rev Allergy Immunol. 2025 Apr 9;68(1):38. doi: 10.1007/s12016-025-09054-1.
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.
结节性痒疹（PN）是一种慢性、严重瘙痒性疾病，显著损害生活质量。现有治疗方法疗效有限，促使人们对白细胞介素-31受体拮抗剂奈莫利珠单抗进行研究。这项荟萃分析评估了在PN患者中比较奈莫利珠单抗与安慰剂的随机对照试验（RCT）。有效性终点包括峰值瘙痒数字评定量表（PP-NRS4）改善≥4分、研究者整体评估（IGA）降低≥2分以及睡眠障碍数字评定量表（SD-NRS）改善≥4分。三项涉及497例患者的RCT符合纳入标准。汇总分析显示，奈莫利珠单抗显著增加了达到PP-NRS4反应的可能性（OR = 6.92，95%CI：3.84 - 12.45，P <.00001）、IGA降低（OR = 7.59，95%CI：3.58 - 16.12，P <.00001）以及SD-NRS改善（OR = 3.99，95%CI：2.39 - 6.66，P <.00001）。在不良事件、严重不良事件或其他特定类别方面，奈莫利珠单抗与安慰剂的安全性结果无显著差异。总之，奈莫利珠单抗在保持良好安全性的同时，在减轻PN患者的瘙痒、皮损严重程度和睡眠障碍方面显示出强大的疗效。虽然这些发现很有前景，但纳入研究数量较少以及存在发表偏倚的可能性需要谨慎解读，并突出了进一步研究的必要性。这些发现支持了其作为对标准治疗无反应的PN患者的一种有前景选择的作用。
