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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:一项随机临床试验的荟萃分析

Efficacy and safety of upadacitinib for the treatment of moderate-to-severe atopic dermatitis: a meta-analysis of randomized clinical trials.

作者信息

Zeng Linxi, Feng Sen, Yao Lulu, Wang Bin, Zhang Guoqiang

机构信息

Department of Dermatology, The First Hospital of Hebei Medical University, Yuhua District, Shijiazhuang City, Hebei Province, China.

Candidate Branch of National Clinical Research Center for Skin Diseases, Shijiazhuang, China.

出版信息

Postepy Dermatol Alergol. 2023 Dec;40(6):734-740. doi: 10.5114/ada.2023.133959. Epub 2024 Jan 8.

Abstract

INTRODUCTION

Recent studies have confirmed the possibility of using upadacitinib for treating atopic dermatitis (AD). However, there is no meta-analysis to summarize and quantify the efficacy and safety of the drug, especially for adolescents with AD.

AIM

To evaluate the overall efficacy and safety of upadacitinib in adults and adolescents with AD.

MATERIAL AND METHODS

We developed this systematic review and meta-analysis according to PRISMA guidelines. Risk-of-bias assessment tool, RoB2 (revised version 2019) was used for quality assessment.

RESULTS

Four RCTs were enrolled in the analysis, 3 of which on both adults and adolescents, while the other on adults only. For either adults or adolescents, the group treated with upadacitinib all had better performance than controls: EASI-75 (adults): RR = 4.68, 95% CI: 4.09, 5.35; NRS4 (adults): RR = 4.07, 95% CI: 3.15, 5.25; EASI-75 (adolescents): RR = 4.16, 95% CI: 2.70, 6.42; NRS4 (adolescents): RR = 4.52, 95% CI: 2.49, 8.21. Furthermore, upadacitinib 30 mg was more effective than 15 mg. For serious AEs, upper respiratory tract infection and headache, there was no significant difference between the upadacitinib group and controls. However, the treatment of upadacitinib may increase the risk of nasopharyngitis, increase blood creatine phosphokinase and cause acne.

CONCLUSIONS

Upadacitinib seems to be a promising drug for AD. More long-term and larger-sized randomized clinical trials are required to further assess the safety and efficacy of upadacitinib for AD.

摘要

引言

最近的研究证实了使用乌帕替尼治疗特应性皮炎(AD)的可能性。然而,尚无荟萃分析来总结和量化该药物的疗效和安全性,尤其是对于患有AD的青少年。

目的

评估乌帕替尼在成人和青少年AD患者中的总体疗效和安全性。

材料与方法

我们根据PRISMA指南开展了这项系统评价和荟萃分析。采用偏倚风险评估工具RoB2(2019年修订版)进行质量评估。

结果

四项随机对照试验(RCT)纳入分析,其中三项涉及成人和青少年,另一项仅涉及成人。对于成人或青少年,接受乌帕替尼治疗的组均比对照组表现更好:成人达到湿疹面积和严重程度指数改善75%(EASI-75):相对危险度(RR)=4.68,95%置信区间(CI):4.09,5.35;成人数字评定量表(NRS4):RR = 4.07,95%CI:3.15,5.25;青少年EASI-75:RR = 4.16,95%CI:2.70,6.42;青少年NRS4:RR = 4.52,95%CI:2.49,8.21。此外,30mg乌帕替尼比15mg更有效。对于严重不良事件,即上呼吸道感染和头痛,乌帕替尼组与对照组之间无显著差异。然而,乌帕替尼治疗可能会增加鼻咽炎风险、提高血液肌酸磷酸激酶水平并导致痤疮。

结论

乌帕替尼似乎是一种有前景的AD治疗药物。需要更多长期、大样本的随机临床试验来进一步评估乌帕替尼治疗AD的安全性和疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3bf/10809821/eb4956042ac1/PDIA-40-52123-g001.jpg

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