Bouman Chantal A M, van der Maas Aatke, van Herwaarden Noortje, Sasso Eric H, van den Hoogen Frank H J, den Broeder Alfons A
Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
Crescendo Bioscience, San Francisco, CA, USA.
Rheumatology (Oxford). 2017 Jun 1;56(6):973-980. doi: 10.1093/rheumatology/kex003.
The aim was to evaluate the predictive value of the baseline multi-biomarker disease activity (MBDA) score in long-standing RA patients with low disease activity tapering TNF inhibitors (TNFi) for successful tapering or discontinuation, occurrence of flare and major flare, and radiographic progression.
Dose REduction Strategies of Subcutaneous TNF inhibitors (Dutch Trial Register, NTR 3216) is an 18-month non-inferiority randomized controlled trial comparing tapering of TNFi until discontinuation or flaring with usual care (UC) in long-standing RA patients with stable low disease activity. Flare was defined as DAS28-CRP increase >1.2 or >0.6 if current DAS ⩾3.2; major flare was a flare lasting >3 months, despite treatment intervention. MBDA scores were measured at baseline. Radiographs were scored at baseline and 18 months using the Sharp-van der Heijde score. The area under the receiver operating characteristic (AUROC) curve was used to analyse the capability of baseline MBDA score to predict the above-mentioned outcomes.
Serum samples and outcomes were available for 171 of 180 patients from Dose REduction Strategies of Subcutaneous TNF inhibitors (115 tapering; 56 UC). AUROC analyses showed that baseline MBDA score was not predictive for the above-mentioned clinical outcomes in the taper group, but did predict major flare in the UC group (AUROC = 0.72, 95% CI: 0.56, 0.88). Radiographic progression was minimal and was not predicted by MDBA score.
In this disease activity-guided strategy study of TNFi tapering in RA patients with low disease activity, baseline MBDA score was not predictive for successful tapering, discontinuation, flare, major flare or radiographic progression in patients who tapered TNFi.
评估基线多生物标志物疾病活动度（MBDA）评分对长期低疾病活动度的类风湿关节炎（RA）患者逐渐减少肿瘤坏死因子抑制剂（TNFi）剂量以实现成功减量或停药、病情复发及严重复发以及影像学进展的预测价值。
皮下注射肿瘤坏死因子抑制剂减量策略（荷兰试验注册编号：NTR 3216）是一项为期18个月的非劣效性随机对照试验，比较在病情稳定且低疾病活动度的长期RA患者中，逐渐减少TNFi剂量直至停药或病情复发与常规治疗（UC）的效果。病情复发定义为：若当前疾病活动度评分（DAS）≥3.2，则DAS28-CRP升高>1.2或>0.6；严重复发是指尽管进行了治疗干预，但病情复发持续>3个月。在基线时测量MBDA评分。使用Sharp-van der Heijde评分在基线和18个月时对X线片进行评分。采用受试者工作特征（AUROC）曲线下面积分析基线MBDA评分预测上述结局的能力。
皮下注射肿瘤坏死因子抑制剂减量策略研究中180例患者中的171例（115例减量组；56例常规治疗组）有血清样本和结局数据。AUROC分析显示，基线MBDA评分在减量组中对上述临床结局无预测价值，但在常规治疗组中可预测严重复发（AUROC = 0.72，95%置信区间：0.56，0.88）。影像学进展极小，且MDBA评分无法预测。
在这项针对低疾病活动度RA患者TNFi减量的疾病活动度指导策略研究中，基线MBDA评分对TNFi减量患者的成功减量、停药、病情复发、严重复发或影像学进展无预测价值。
