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在持续缓解的早期关节炎患者中逐渐减少传统合成 DMARDs:tREACH 试验的 2 年随访。

Tapering conventional synthetic DMARDs in patients with early arthritis in sustained remission: 2-year follow-up of the tREACH trial.

机构信息

Department of Rheumatology, Maasstad Hospital, Rotterdam, The Netherlands.

Department of Rheumatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.

出版信息

Ann Rheum Dis. 2016 Dec;75(12):2119-2123. doi: 10.1136/annrheumdis-2016-209272. Epub 2016 Jun 9.

Abstract

OBJECTIVES

With early and intensive treatment many patients with early RA attain remission. Aims were to investigate (1) the frequency and time to sustained remission and subsequent tapering in patients initially treated with conventional synthetic disease modifying anti-rheumatic drug ((cs)DMARD) strategies and (2) the frequency and time to flare and regained remission in patients tapering csDMARDs and biological (b)DMARDs during 2 years of follow-up.

METHODS

Two-year follow-up data from the treatment in the Rotterdam Early Arthritis Cohort (tREACH) cohort were used. Patients were randomised to initial treatment with triple DMARD therapy (iTDT) with glucocorticoid (GC) bridging or methotrexate monotherapy (iMM) with GC bridging. Patients were evaluated every 3 months. In case Disease Activity Score (DAS) was >2.4 treatment was switched to a TNF-blocker. In case DAS<1.6 at 2 consecutive time points, tapering was initiated according to protocol. Outcomes were rates of sustained remission (DAS<1.6 at 2 consecutive time points), flare (medication increase after tapering) and remission after flare (DAS<1.6). Data were analysed using Kaplan-Meier analyses.

RESULTS

During 2 years of follow-up, sustained remission was achieved at least once by 159 (57%) of patients, of whom 118 and 23 patients initiated tapering of csDMARDs and bDMARDs, respectively. Thirty-four patients achieved drug-free remission. Flare rates were 41% and 37% and within 1 year, respectively. After flare, 65% of patients tapering csDMARDs re-achieved remission within 6 months after treatment intensification.

CONCLUSIONS

Regardless of initial treatment strategy, 57% of patients achieved sustained remission during 2 years of follow-up. Flare rates were 41% and 37% within 12 months in patients tapering csDMARDs and bDMARDs, respectively.

TRIAL REGISTRATION NUMBER

ISRCTN26791028; Post-results.

摘要

目的

通过早期和强化治疗,许多早期类风湿关节炎患者可达到缓解。本研究旨在探讨:(1)初始接受传统合成改善病情抗风湿药(csDMARD)治疗方案的患者达到持续缓解和随后逐渐减药的频率和时间;(2)在 2 年随访期间,逐渐减用 csDMARD 和生物制剂(bDMARD)的患者出现病情复发和恢复缓解的频率和时间。

方法

本研究使用了 Rotterdam Early Arthritis Cohort(tREACH)队列的 2 年随访数据。患者被随机分为初始三联 DMARD 治疗(iTDT)联合糖皮质激素(GC)桥接或甲氨蝶呤单药治疗(iMM)联合 GC 桥接。患者每 3 个月接受一次评估。如果疾病活动评分(DAS)>2.4,则转换为 TNF 抑制剂治疗。如果连续 2 次时间点 DAS<1.6,则根据方案开始逐渐减药。主要结局为持续缓解(连续 2 次时间点 DAS<1.6)、复发(减药后药物增加)和复发后缓解(DAS<1.6)的发生率。使用 Kaplan-Meier 分析进行数据分析。

结果

在 2 年的随访期间,159 名(57%)患者至少有一次达到持续缓解,其中 118 名和 23 名患者分别开始逐渐减用 csDMARD 和 bDMARD。34 名患者达到无药物缓解。复发率分别为 41%和 37%,均在 1 年内。在复发后,65%逐渐减用 csDMARD 的患者在强化治疗后 6 个月内再次达到缓解。

结论

无论初始治疗策略如何,在 2 年的随访期间,57%的患者达到持续缓解。在逐渐减用 csDMARD 和 bDMARD 的患者中,12 个月内的复发率分别为 41%和 37%。

临床试验注册

ISRCTN26791028;post-results。

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