Division of Rheumatology, Medical University Vienna, Vienna, Austria.
Division of Rheumatology, Medical University Vienna, Vienna, Austria Second Department of Medicine, Hietzing Hospital, Vienna, Austria.
Ann Rheum Dis. 2016 Aug;75(8):1479-85. doi: 10.1136/annrheumdis-2015-208324. Epub 2015 Sep 29.
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.
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.
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.
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.
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。
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。
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。
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。