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依那西普治疗类风湿关节炎的有效性:来自德国非干预性研究ADEQUATE的真实世界数据,重点关注达标治疗和患者报告的结局。

Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes.

作者信息

Feist Eugen, Baraliakos Xenofon, Behrens Frank, Thaçi Diamant, Klopsch Thilo, Plenske Anja, Blindzellner Lisa K, Klaus Pascal, Meng Thomas, Löschmann Peter-Andreas

机构信息

Department of Rheumatology, Helios Fachklinik, Sophie-von-Boetticher-Straße 1, 39245, Vogelsang-Gommern, Germany.

Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.

出版信息

Rheumatol Ther. 2022 Apr;9(2):621-635. doi: 10.1007/s40744-021-00418-5. Epub 2022 Feb 3.

DOI:10.1007/s40744-021-00418-5
PMID:35113363
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8964852/
Abstract

BACKGROUND

For rheumatoid arthritis (RA), the treat-to-target concept suggests attaining remission or at least low disease activity (LDA) after 12 weeks.

OBJECTIVES

This German, prospective, multicenter, non-interventional study aimed to determine the proportion of patients with RA who achieved their treat-to-target aim after 12 and 24 weeks of etanercept (ETN) treatment in a real-life setting, as opposed to patients achieving their therapeutic target at a later timepoint (week 36 or 52).

METHODS

A total of 824 adults with a confirmed diagnosis of RA without prior ETN treatment were included. Remission and LDA were defined as DAS28 < 2.6 and DAS28 ≤ 3.2, respectively.

RESULTS

The proportion of patients achieving remission was 24% at week 12 and 31% at week 24. The proportion of patients achieving LDA was 39% at week 12 and 45% at week 24. The proportion of patients achieving remission or LDA further increased beyond week 24 up to week 52. Improvement in pain and reduction in concomitant glucocorticoid treatment were observed. Improvements in patient-reported outcomes were also seen in patients who did not reach remission or LDA. No new safety signals were detected.

CONCLUSIONS

A considerable proportion of patients with RA attained the target of remission or LDA after 12 weeks of ETN treatment. Even beyond that timepoint, the proportion of patients achieving treatment targets continued to increase up to week 52.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02486302.

摘要

背景

对于类风湿关节炎(RA),治疗达标理念建议在12周后实现缓解或至少达到低疾病活动度(LDA)。

目的

这项德国前瞻性多中心非干预性研究旨在确定在现实环境中接受依那西普(ETN)治疗12周和24周后达到治疗达标目标的RA患者比例,与在更晚时间点(第36周或52周)达到治疗目标的患者进行对比。

方法

共纳入824名确诊为RA且未接受过ETN治疗的成年人。缓解和LDA分别定义为DAS28<2.6和DAS28≤3.2。

结果

第12周时达到缓解的患者比例为24%,第24周时为31%。第12周时达到LDA的患者比例为39%,第24周时为45%。达到缓解或LDA的患者比例在第24周后至第52周进一步增加。观察到疼痛改善和糖皮质激素联合治疗减少。未达到缓解或LDA的患者在患者报告结局方面也有改善。未检测到新的安全信号。

结论

相当一部分RA患者在ETN治疗12周后达到缓解或LDA目标。即使超过该时间点,达到治疗目标的患者比例在第52周前仍持续增加。

试验注册

ClinicalTrials.gov标识符:NCT02486302。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/bd80f18c486a/40744_2021_418_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/be6fef2a0849/40744_2021_418_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/2ae7ca1425da/40744_2021_418_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/bd80f18c486a/40744_2021_418_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/be6fef2a0849/40744_2021_418_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/2ae7ca1425da/40744_2021_418_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a5/8964852/bd80f18c486a/40744_2021_418_Fig3_HTML.jpg

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