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初治类风湿关节炎患者应用肿瘤坏死因子抑制剂联合合成改善病情抗风湿药治疗:意大利专家共识改良版推荐意见。

Immediate treatment with tumour necrosis factor inhibitors in synthetic disease-modifying anti-rheumatic drugs-naïve patients with rheumatoid arthritis: results of a modified Italian Expert Consensus.

机构信息

Department of Medical Sciences, University of Ferrara and Azienda Ospedaliero-Universitaria Sant'Anna, Cona (Ferrara).

Dipartimento di Clinica e Terapia Medica, Sapienza Università di Roma, Reumatologia, Roma.

出版信息

Rheumatology (Oxford). 2018 Oct 1;57(57 Suppl 7):vii32-vii41. doi: 10.1093/rheumatology/key076.

Abstract

OBJECTIVE

To establish clinical consensus for the optimal placement of TNF inhibitor (TNFi) in DMARDs-naïve RA patients.

METHODS

The steering group was composed of 15 Italian rheumatologists expert in the field of RA, who proposed and selected by consensus the clinically relevant questions on the role of TNFi treatment in DMARDs-naïve RA patients. The question was rephrased according to the population, intervention, comparison and outcome statement. The available scientific evidence on this topic were collected by updating the systematic literature reviews used for the EULAR 2013 recommendations up to January 2016. The aspects evaluated in the studies concerned clinical efficacy, radiographic structural damage and safety. After the systematic literature review the expert panel formulated a consensus statement, and a modified Delphi panel evaluated the level of agreement between panellists (strength of recommendation).

RESULTS

From a total of 1080 records we have included 6 studies, 2 randomized clinical trials and 4 open-label extension trials. Evidence from publications generated three statements for the final consensus document. The systematic literature review and the consensus statements developed showed that, for patients with early RA and in the presence of a treat-to-target strategy, the immediate use of anti-TNFi compared with an early (within 12 weeks) step-up to anti-TNF therapy did not confer a significant advantage regarding clinical, functional and radiographic outcomes.

CONCLUSION

The most appropriate placement of the TNFi therapy in the treatment algorithm of early RA still remains a challenging clinical question that needs to be further addressed.

摘要

目的

为 TNF 抑制剂(TNFi)在初治类风湿关节炎(RA)患者中的最佳应用建立临床共识。

方法

指导小组由 15 名意大利风湿病学专家组成,他们就 TNFi 治疗在初治 RA 患者中的作用提出并通过共识选择了具有临床相关性的问题。根据人群、干预、比较和结局陈述重新表述了问题。根据 EULAR 2013 年建议的系统综述进行更新,收集了该主题的现有科学证据,更新截止日期为 2016 年 1 月。研究中评估的方面包括临床疗效、影像学结构损伤和安全性。系统文献复习后,专家小组制定了共识声明,并由改良 Delphi 小组评估小组专家之间的一致性(推荐强度)。

结果

共纳入 1080 篇记录,其中包括 6 项研究,2 项随机临床试验和 4 项开放标签扩展试验。文献来源产生了三个声明,纳入最终共识文件。系统文献复习和制定的共识声明表明,对于早期 RA 患者,且采用治疗目标策略时,与早期(12 周内)加用抗 TNF 治疗相比,立即使用抗 TNFi 治疗并不会在临床、功能和影像学结局方面带来显著优势。

结论

TNFi 治疗在早期 RA 治疗方案中的最佳应用仍是一个具有挑战性的临床问题,需要进一步研究。

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