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类风湿关节炎的达标治疗优化:3 个月时间点的策略。

Optimisation of a treat-to-target approach in rheumatoid arthritis: strategies for the 3-month time point.

机构信息

Division of Rheumatology, Medical University Vienna, Vienna, Austria.

Division of Rheumatology, Medical University Vienna, Vienna, Austria Second Department of Medicine, Hietzing Hospital, Vienna, Austria.

出版信息

Ann Rheum Dis. 2016 Aug;75(8):1479-85. doi: 10.1136/annrheumdis-2015-208324. Epub 2015 Sep 29.

DOI:10.1136/annrheumdis-2015-208324
PMID:26420577
Abstract

BACKGROUND

Treat-to-target (T2T) is a widely accepted management strategy for rheumatoid arthritis (RA) with a key decision point at 3 months after treatment initiation. At this time point, it remains unclear which patients will benefit from treatment adaptation or from continuation of existing treatment.

METHODS

We performed a pooled analysis of patient-level clinical trial data of patients with RA. We used a diagnostic testing methodology and a probabilistic approach employing logistic regression to investigate which levels of response at 3 months can inform treatment decisions in regard to achieving the target at 6 months.

RESULTS

To be at least 80% sensitive for achieving the low disease activity (LDA) target at 6 months, a change at 3 months in Simplified Disease Activity Index/Clinical Disease Activity Index (SDAI or CDAI) of 58% needs to be observed at 3 months. Higher changes are needed to sensitively predict remission (REM). Not reaching the (minor) SDAI 50% response level is afflicted with very low negative likelihood ratios (LRs) (0.28 for LDA and 0.07 for REM at 6 months). Experiencing (major) SDAI 85% response has substantial positive LRs of 9.2 for reaching LDA and 6.2 for reaching REM at 6 months. In logistic regression, the change at 3 months is significantly associated with reaching of the target at 6 months.

CONCLUSIONS

The 3-month time point is a critical decision point. Not achieving minor responses at 3 months makes reaching of the treatment target at 6 months highly unlikely, while reaching major responses is highly predictive of reaching the treatment target.

摘要

背景

达标治疗(T2T)是一种广泛接受的类风湿关节炎(RA)管理策略,其关键决策点是在治疗开始后 3 个月。此时,尚不清楚哪些患者将从治疗调整中受益,哪些患者将从继续现有治疗中受益。

方法

我们对 RA 患者的临床试验患者水平数据进行了汇总分析。我们使用诊断测试方法和概率方法,采用逻辑回归来研究 3 个月时的哪些反应水平可以为 6 个月时达到目标提供信息。

结果

要达到 6 个月时的低疾病活动(LDA)目标,至少有 80%的敏感性,需要在 3 个月时观察到简化疾病活动指数/临床疾病活动指数(SDAI 或 CDAI)变化 58%。更高的变化需要更敏感地预测缓解(REM)。未达到(次要)SDAI 50%反应水平的患者,其负似然比(LR)非常低(6 个月时 LDA 为 0.28,REM 为 0.07)。达到(主要)SDAI 85%反应的患者具有较高的正 LR,达到 LDA 的 LR 为 9.2,达到 REM 的 LR 为 6.2。在逻辑回归中,3 个月时的变化与 6 个月时的目标达成显著相关。

结论

3 个月的时间点是一个关键的决策点。3 个月时未达到轻微反应,使 6 个月时达到治疗目标的可能性非常小,而达到主要反应则高度预测达到治疗目标。

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