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托法替布与阿达木单抗治疗类风湿关节炎患者的疗效及安全性比较:一项系统评价与荟萃分析

Comparative effectiveness and safety of tofacitinib vs. adalimumab in patients with rheumatoid arthritis: A systematic review and meta-analysis.

作者信息

Zhu Chunyan, Zheng Yibo, Wang Zilu, Chen Guozong, Li Yushi

机构信息

Department of Rheumatism and immunology, Dongying People's Hospital (Dongying Hospital of Shandong Provincial Hospital Group), Dongying, Shandong, China.

Department of Rehabilitation Medicine, Dongying People's Hospital (Dongying Hospital of Shandong Provincial Hospital Group), Dongying, Shandong, China.

出版信息

Front Pharmacol. 2025 Jun 9;16:1524214. doi: 10.3389/fphar.2025.1524214. eCollection 2025.

DOI:10.3389/fphar.2025.1524214
PMID:40552144
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12183229/
Abstract

OBJECTIVES

To provide the latest systematic review and meta-analysis comparing the effectiveness and safety of tofacitinib and adalimumab in rheumatoid arthritis (RA) patients.

METHODS

A systematic search of PubMed, Embase, Web of Science, and Cochrane databases was conducted until April 2025. Randomized controlled trials and cohorts comparing tofacitinib and adalimumab in RA patients were included. Outcomes assessed were significant improvements in American College of Rheumatology (ACR) 20 improvement criteria, changes in visual analog scale (VAS) (global activity), disease activity score (DAS) 28-C-reactive protein (CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), and adverse events. Sensitivity analyses and subgroup analysis evaluated the robustness of results and heterogeneity. Data analysis was performed using Review Manager 5.4.1 and STATA 15.0.

RESULTS

Nine studies with 24,643 patients were analyzed. Tofacitinib showed superior effectiveness over adalimumab in ACR20 (risk ratio (RR): 1.28; 95% CI: 1.06, 1.55; P = 0.01), HAQ-DI (standardized mean difference (SMD): 0.20; 95% CI: 0.35, -0.05; P = 0.008), and VAS (SMD: 0.30; 95% CI: 0.56, -0.03; P = 0.03). No significant differences were found in adverse events (RR: 0.96; 95% CI: 0.89, 1.03; P = 0.22) or DSA28-CRP improvement (SMD: 0.02; 95% CI: 0.45, 0.02; P = 0.07). Sensitivity analyses confirmed stable outcomes for adverse events, HAQ-DI, and ACR20, but instability for VAS and DSA28-CRP. Subgroup analysis found that tofacitinib >5 mg twice daily was superior to ≤5 mg in terms of ACR20.

CONCLUSION

Tofacitinib was more effective than adalimumab in improving ACR20, VAS, and HAQ-DI, with no significant differences in adverse events or DSA28-CRP improvement.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/.

摘要

目的

提供最新的系统评价和荟萃分析,比较托法替布和阿达木单抗在类风湿关节炎(RA)患者中的有效性和安全性。

方法

对PubMed、Embase、Web of Science和Cochrane数据库进行系统检索,直至2025年4月。纳入比较托法替布和阿达木单抗在RA患者中的随机对照试验和队列研究。评估的结果包括美国风湿病学会(ACR)20改善标准的显著改善、视觉模拟量表(VAS)(整体活动度)变化、疾病活动评分(DAS)28- C反应蛋白(CRP)、健康评估问卷残疾指数(HAQ-DI)以及不良事件。敏感性分析和亚组分析评估了结果的稳健性和异质性。使用Review Manager 5.4.1和STATA 15.0进行数据分析。

结果

分析了9项研究,共24643例患者。在ACR20(风险比(RR):1.28;95%置信区间:1.06,1.55;P = 0.01)、HAQ-DI(标准化均数差(SMD):0.20;95%置信区间:0.35,-0.05;P = 0.008)和VAS(SMD:0.30;95%置信区间:0.56,-0.03;P = 0.03)方面,托法替布显示出优于阿达木单抗的有效性。在不良事件(RR:0.96;95%置信区间:0.89,1.03;P = 0.22)或DSA28-CRP改善(SMD:0.02;95%置信区间:0.45,0.02;P = 0.07)方面未发现显著差异。敏感性分析证实了不良事件、HAQ-DI和ACR20结果的稳定性,但VAS和DSA28-CRP结果不稳定。亚组分析发现,每日两次服用托法替布>5 mg在ACR20方面优于≤5 mg。

结论

托法替布在改善ACR20、VAS和HAQ-DI方面比阿达木单抗更有效,在不良事件或DSA28-CRP改善方面无显著差异。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec74/12183229/aa7d22fe8825/fphar-16-1524214-g006.jpg
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