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类风湿关节炎患者使用 TNF-α 抑制剂的不良反应风险:一项网络荟萃分析。

The Risk of Adverse Effects of TNF-α Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis.

机构信息

Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.

Institute of Clinical Pharmacy, Central South University, Changsha, China.

出版信息

Front Immunol. 2022 Feb 16;13:814429. doi: 10.3389/fimmu.2022.814429. eCollection 2022.

Abstract

OBJECTIVES

To evaluate the safety of each anti-TNF therapy for patients with rheumatoid arthritis (RA) and then make the best choice in clinical practice.

METHODS

We searched PUBMED, EMBASE, and the Cochrane Library. The deadline for retrieval is August 2021. The ORs, Confidence Intervals (CIs), and p values were calculated by STATA.16.0 software for assessment.

RESULT

72 RCTs involving 28332 subjects were included. AEs were more common with adalimumab combined disease-modifying anti-rheumatic drugs (DMARDs) compared with placebo (OR = 1.60, 95% CI: 1.06, 2.42), DMARDs (1.28, 95% CI: 1.08, 1.52), etanercept combined DMARDs (1.32, 95% CI: 1.03, 1.67); certolizumab combined DMARDs compared with placebo (1.63, 95% CI: 1.07, 2.46), DMARDs (1.30, 95% CI: 1.10, 1.54), etanercept combined DMARDs (1.34, 95% CI: 1.05, 1.70). In SAEs, comparisons between treatments showed adalimumab (0.20, 95% CI: 0.07, 0.59), etanercept combined DMARDs (0.39, 95% CI: 0.15, 0.96), golimumab (0.19, 95% CI: 0.05, 0.77), infliximab (0.15, 95% CI: 0.03,0.71) decreased the risk of SAEs compared with golimumab combined DMARDs. In infections, comparisons between treatments showed adalimumab combined DMARDs (0.59, 95% CI: 0.37, 0.95), etanercept (0.49, 95% CI: 0.28, 0.88), etanercept combined DMARDs (0.56, 95% CI: 0.35, 0.91), golimumab combined DMARDs (0.51, 95% CI: 0.31, 0.83) decreased the risk of infections compared with infliximab combined DMARDs. No evidence indicated that the use of TNF-α inhibitors influenced the risk of serious infections, malignant tumors.

CONCLUSION

In conclusion, we regard etanercept monotherapy as the optimal choice for RA patients in clinical practice when the efficacy is similar. Conversely, certolizumab + DMARDs therapy is not recommended.

SYSTEMATIC REVIEW REGISTRATION

identifier PROSPERO CRD42021276176.

摘要

目的

评估每种用于治疗类风湿关节炎(RA)患者的抗 TNF 治疗药物的安全性,然后在临床实践中做出最佳选择。

方法

我们检索了 PUBMED、EMBASE 和 Cochrane 图书馆。检索截止日期为 2021 年 8 月。采用 STATA.16.0 软件计算比值比(OR)、置信区间(CI)和 p 值进行评估。

结果

共纳入 72 项 RCT 研究,涉及 28332 例受试者。与安慰剂相比,阿达木单抗联合改善病情抗风湿药(DMARDs)(OR=1.60,95%CI:1.06,2.42)、DMARDs(1.28,95%CI:1.08,1.52)、依那西普联合 DMARDs(1.32,95%CI:1.03,1.67)发生不良事件(AE)的风险更高;与安慰剂(OR=1.63,95%CI:1.07,2.46)、DMARDs(1.30,95%CI:1.10,1.54)、依那西普联合 DMARDs(1.34,95%CI:1.05,1.70)相比,培塞丽珠单抗联合 DMARDs 发生 AE 的风险更高。在严重不良事件(SAE)方面,与戈利木单抗联合 DMARDs 相比,阿达木单抗(0.20,95%CI:0.07,0.59)、依那西普联合 DMARDs(0.39,95%CI:0.15,0.96)、戈利木单抗(0.19,95%CI:0.05,0.77)、英夫利昔单抗(0.15,95%CI:0.03,0.71)降低了 SAE 的风险。在感染方面,与戈利木单抗联合 DMARDs 相比,阿达木单抗联合 DMARDs(0.59,95%CI:0.37,0.95)、依那西普(0.49,95%CI:0.28,0.88)、依那西普联合 DMARDs(0.56,95%CI:0.35,0.91)、戈利木单抗联合 DMARDs(0.51,95%CI:0.31,0.83)降低了感染的风险。没有证据表明 TNF-α 抑制剂的使用会影响严重感染和恶性肿瘤的风险。

结论

综上所述,当疗效相似时,我们认为依那西普单药治疗是 RA 患者临床实践中的最佳选择。相反,不推荐使用培塞丽珠单抗+DMARDs 治疗。

系统评价注册

标识符 PROSPERO CRD42021276176。

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