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类风湿关节炎传统改善病情抗风湿药治疗失败后各治疗方案的比较疗效

Comparative effectiveness of treatment options after conventional DMARDs failure in rheumatoid arthritis.

作者信息

Sung Yoon-Kyoung, Cho Soo-Kyung, Kim Dam, Choi Chan-Bum, Won Soyoung, Bang So-Young, Cha Hoon-Suk, Choe Jung-Yoon, Chung Won Tae, Hong Seung-Jae, Jun Jae-Bum, Kim Hyoun Ah, Kim Jinseok, Kim Seong-Kyu, Kim Tae-Hwan, Lee Hye-Soon, Lee Jaejoon, Lee Jisoo, Lee Shin-Seok, Lee Sung Won, Lee Yeon-Ah, Nah Seong-Su, Suh Chang-Hee, Yoo Dae-Hyun, Yoon Bo Young, Bae Sang Cheol

机构信息

Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 04763, South Korea.

Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.

出版信息

Rheumatol Int. 2017 Jun;37(6):975-982. doi: 10.1007/s00296-016-3649-2. Epub 2017 Jan 28.

Abstract

OBJECTIVE

To compare the clinical effectiveness of two treatment strategies for active rheumatoid arthritis (RA) refractory to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs): starting TNF inhibitors (TNFIs) or changing csDMARDs.

METHODS

We used two nationwide Korean RA registries for patient selection. TNFI users were selected from the BIOPSY, which is an inception cohort of RA patients starting biologic DMARDs. As a control group, we selected RA patients with moderate or high disease activity from the KORONA database whose treatment was changed to other csDMARDs. After comparing baseline characteristics between the two groups in either unmatched or propensity score matched cohorts, we compared potential differences in the 1-year remission rate as a primary outcome and changes in HAQ-DI and EQ-5D scores as secondary outcomes.

RESULTS

A total of 356 TNFI starters and 586 csDMARD changers were identified from each registry as unmatched cohorts, and 294 patients were included in the propensity score matched cohort. In the intention-to-treat analysis, TNFI starters had higher 1-year remission rates than csDMARD changers in both unmatched (19.1 vs. 18.4%, p < 0.01) and matched cohorts (19.7 vs. 15.0%, p < 0.01). In per protocol analysis, TNFI starters had much higher remission rates in unmatched (37.2 vs. 28.0%, p = 0.04) and matched cohorts (35.4 vs. 19.1%, p = 0.04). However, in matched cohorts, no significant differences were observed between two groups in HAQ-DI and EQ-5D scores.

CONCLUSIONS

We compared the clinical effectiveness of the two treatment strategies for active RA refractory to csDMARDs. TNFI starters showed higher 1-year remission rates than csDMARD changers.

摘要

目的

比较两种治疗策略对常规合成抗风湿药物(csDMARDs)难治的活动性类风湿关节炎(RA)的临床疗效:起始使用肿瘤坏死因子抑制剂(TNFIs)或更换csDMARDs。

方法

我们使用两个韩国全国性的RA登记系统进行患者选择。TNFI使用者从BIOPSY中选取,BIOPSY是一个开始使用生物DMARDs的RA患者起始队列。作为对照组,我们从KORONA数据库中选取疾病活动度为中度或高度的RA患者,其治疗更换为其他csDMARDs。在未匹配或倾向评分匹配队列中比较两组的基线特征后,我们比较了作为主要结局的1年缓解率以及作为次要结局的HAQ-DI和EQ-5D评分的变化。

结果

从每个登记系统中分别确定了356名起始使用TNFI者和586名更换csDMARDs者作为未匹配队列,倾向评分匹配队列纳入了294名患者。在意向性分析中,起始使用TNFI者在未匹配队列(19.1%对18.4%,p<0.01)和匹配队列(19.7%对15.0%,p<0.01)中的1年缓解率均高于更换csDMARDs者。在符合方案分析中,起始使用TNFI者在未匹配队列(37.2%对28.0%,p=0.04)和匹配队列(35.4%对19.1%,p=0.04)中的缓解率要高得多。然而,在匹配队列中,两组在HAQ-DI和EQ-5D评分方面未观察到显著差异。

结论

我们比较了两种治疗策略对csDMARDs难治的活动性RA的临床疗效。起始使用TNFI者的1年缓解率高于更换csDMARDs者。

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