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Nemolizumab 治疗瘙痒性特应性皮炎的安全性和疗效:一项随机对照试验的系统评价和荟萃回归分析。

Safety and Efficacy of Nemolizumab for Atopic Dermatitis With Pruritus: A Systematic Review and Meta-Regression Analysis of Randomized Controlled Trials.

机构信息

Department of Dermatology and Venereology, People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Clinical Research Center for Dermatologic Diseases, Xinjiang Key Laboratory of Dermatology Research (XJYS1707), Urumqi, China.

出版信息

Front Immunol. 2022 Apr 26;13:825312. doi: 10.3389/fimmu.2022.825312. eCollection 2022.

Abstract

BACKGROUND

Nemolizumab is deemed as a promising drug for atopic dermatitis (AD) patients with pruritus.

OBJECTIVE

This study aimed to evaluate the efficacy of nemolizumab in treating patients with AD and the association between the dosage or regimen of nemolizumab with the improvement in clinical indices.

METHODS AND MATERIALS

PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs) published from inception to August 2021.

RESULTS

A total of 14 cohorts of participants from six randomized controlled studies were included in the meta-analysis. Nemolizumab significantly reduced the pruritus VAS (WMD = -18.86, 95% CI: -27.57 to -10.15,  < 0.001;  = 56.2%,  = 0.005) and EASI (WMD = -11.76, 95% CI: -20.55 to -2.96,  = 0.009;  = 0%,  = 0.978) scores compared with placebo. No significant difference was observed in the occurrence of any AEs (RR = 1.03, 95% CI: 0.93 to 1.13,  = 0.593;  = 0%,  = 0.980) between the two groups. The univariate meta-regression showed that both the dosage and study duration had no association with the change of pruritus VAS score.

CONCLUSION

Nemolizumab presented a promising effect based on the difference in the average change in pruritus VAS and EASI scores compared with placebo. The results indicated its efficacy in relieving pruritus and the severity of AD and improving patients' quality of life.

摘要

背景

Nemolizumab 被认为是一种有前途的治疗特应性皮炎(AD)患者瘙痒的药物。

目的

本研究旨在评估 nemolizumab 治疗 AD 患者的疗效,以及 nemolizumab 的剂量或方案与临床指标改善之间的关系。

方法和材料

检索了从成立到 2021 年 8 月发表的 PubMed、Embase 和 Cochrane Library 中的随机对照试验(RCT)。

结果

共有来自六项随机对照研究的 14 组参与者被纳入荟萃分析。与安慰剂相比,Nemolizumab 显著降低了瘙痒 VAS(WMD=-18.86,95%CI:-27.57 至-10.15,<0.001;=56.2%,=0.005)和 EASI(WMD=-11.76,95%CI:-20.55 至-2.96,=0.009;=0%,=0.978)评分。两组之间任何 AEs(RR=1.03,95%CI:0.93 至 1.13,=0.593;=0%,=0.980)的发生率无显著差异。单变量 meta 回归显示,剂量和研究持续时间与瘙痒 VAS 评分的变化均无关联。

结论

与安慰剂相比,Nemolizumab 在瘙痒 VAS 和 EASI 评分的平均变化差异方面表现出良好的效果。结果表明,它在缓解瘙痒和 AD 严重程度以及提高患者生活质量方面具有疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00ff/9086972/0e4f66b88bc5/fimmu-13-825312-g001.jpg

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