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乌帕替尼治疗中度至重度特应性皮炎的疗效和安全性:一项系统评价和荟萃分析。

Efficacy and safety of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis.

作者信息

Lin Jinger, Luo Min, Zhuo Qianwei, Chen Nuo, Zhang Haosong, Han Yue

机构信息

Department of Dermatology, The Union Hospital, Fujian Medical University, Fuzhou, China.

出版信息

Front Pharmacol. 2024 Nov 19;15:1429709. doi: 10.3389/fphar.2024.1429709. eCollection 2024.

Abstract

BACKGROUND

Lebrikizumab, an IL-13 immunomodulator, has shown recommendable effectiveness and safety in clinical studies for the treatment of moderate-to-severe atopic dermatitis (AD) in adolescents and adults.

OBJECTIVE

To evaluate the efficacy and safety of lebrikizumab in the treatment of moderate-to-severe AD through a meta-analysis.

METHODS

PubMed, Embase, Web of Science, Medline, and ClinicalTrials.gov databases were searched up to 8 August 2023. Randomized clinical trials of lebrikizumab treatment for moderate-to-severe AD were included by screening titles, abstracts, and papers.

RESULTS

Five studies involving 1,551 patients with AD were identified. Pooled analysis revealed significant improvements in the Eczema Area and Severity Index (EASI) score (SMD = -0.527; 95% CI = [-0.617, -0.436]), Investigator's Global Assessment (IGA) score (RR = 2.122; 95% CI = [1.803, 2.496]), Body Surface Area (BSA) score (SMD = -0.608; 95% CI = [-1.099, -0.118]), SCORing Atopic Dermatitis (SCORAD) score (SMD = -0.441; 95% CI = [-0.633, -0.250]). Moreover, Pruritus Numeric Rating Scale (P-NRS) score, Patient-oriented Eczema Measure (POEM) scores, Sleep-loss score and Dermatology Life Quality Index (DLQI) scores showed similar results. Adverse events (AEs) (RR = 0.984; 95% CI = [0.907, 1.068]) for lebrikizumab showed no statistically significant difference compared to placebo, with similar results for serious adverse events (SAEs) (RR = 0.748; 95% CI = [0.410, 1.364]).

CONCLUSION

This meta-analysis reveals that lebrikizumab has higher efficacy and safety in the treatment of moderate-to-severe AD, with the 250 mg Q2W dosage regimen appearing to be more advantageous.

摘要

背景

瑞莎珠单抗是一种白细胞介素-13免疫调节剂,在青少年和成人中重度特应性皮炎(AD)的临床治疗研究中显示出了良好的有效性和安全性。

目的

通过荟萃分析评估瑞莎珠单抗治疗中重度AD的疗效和安全性。

方法

检索截至2023年8月8日的PubMed、Embase、Web of Science、Medline和ClinicalTrials.gov数据库。通过筛选标题、摘要和论文,纳入瑞莎珠单抗治疗中重度AD的随机临床试验。

结果

共纳入5项研究,涉及1551例AD患者。汇总分析显示,湿疹面积和严重程度指数(EASI)评分(标准化均值差= -0.527;95%置信区间= [-0.617, -0.436])、研究者整体评估(IGA)评分(相对危险度= 2.122;95%置信区间= [1.803, 2.496])、体表面积(BSA)评分(标准化均值差= -0.608;95%置信区间= [-1.099, -0.118])、特应性皮炎评分(SCORAD)(标准化均值差= -0.441;95%置信区间= [-0.633, -0.250])均有显著改善。此外,瘙痒数字评定量表(P-NRS)评分、患者导向性湿疹评估(POEM)评分、睡眠障碍评分和皮肤病生活质量指数(DLQI)评分也显示出类似结果。与安慰剂相比,瑞莎珠单抗的不良事件(AE)(相对危险度= 0.984;95%置信区间= [0.907, 1.068])无统计学显著差异,严重不良事件(SAE)(相对危险度= 0.748;95%置信区间= [0.410, 1.364])结果相似。

结论

本荟萃分析表明,瑞莎珠单抗治疗中重度AD具有较高的疗效和安全性,250mg每2周一次的给药方案似乎更具优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/45b0/11611541/7b783083c05f/fphar-15-1429709-g001.jpg

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