在类风湿关节炎患者达到疾病控制后，逐渐减少 TNF 抑制剂与传统合成 DMARDs 的剂量：随机对照 TARA 研究的第一年结果。
Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study.
机构信息
Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands
Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands.
出版信息
Ann Rheum Dis. 2019 Jun;78(6):746-753. doi: 10.1136/annrheumdis-2018-214970. Epub 2019 Apr 6.
OBJECTIVES
The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up.
METHODS
In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time.
RESULTS
A total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time.
CONCLUSION
Up to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.
TRIAL REGISTRATION NUMBER
NTR2754.
目的
本研究旨在评估在类风湿关节炎（RA）患者达到疾病控制后，1 年随访期间采用两种渐减策略的效果。
方法
在这项多中心、单盲（研究护士）、随机对照试验中，纳入了达到疾病控制的 RA 患者，定义为疾病活动评分（DAS）≤2.4 和肿胀关节计数（SJC）≤1，接受了常规合成改善病情抗风湿药物（csDMARD）和 TNF 抑制剂治疗。符合条件的患者被随机分为逐渐减少 csDMARD 或 TNF 抑制剂。如果 RA 仍处于控制之下，则通过将剂量减半、四分之一，然后停止药物来减少药物剂量。主要结局是疾病复发患者的比例，定义为 DAS>2.4 和/或 SJC>1。次要结局是 1 年后和随时间推移的 DAS、欧洲生活质量 5 维度（EQ5D）和功能能力（健康评估问卷残疾指数[HAQ-DI]）。
结果
共 189 例患者被随机分配至渐减 csDMARD 组（n=94）或渐减抗 TNF 组（n=95）。csDMARD 渐减组和抗 TNF 渐减组的累积复发率分别为 33%（95%CI，24%至 43%）和 43%（95%CI，33%至 53%（p=0.17）。1 年后和随时间推移，渐减组之间的 DAS、HAQ-DI 和 EQ-5D 均值无差异。
结论
在 9 个月内，渐减 csDMARD 或 TNF 抑制剂的复发率相似。1 年后，csDMARD 渐减组有 10%的优势，但差异无统计学意义。因此，渐减 TNF 抑制剂并不优于渐减 csDMARD。从社会角度来看，先渐减 TNF 抑制剂更为合理，因为可能会降低成本和减少长期副作用。
试验注册号
NTR2754。
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