基于多生物标志物疾病活动评分预测肿瘤坏死因子抑制剂减量后类风湿关节炎复发的能力：STRASS 试验的事后分析。
Ability to predict rheumatoid arthritis relapse after tumour necrosis factor inhibitor tapering by the Multi-Biomarker Disease Activity Score: a post-hoc analysis of the STRASS trial.
机构信息
Department of Rheumatology, Sorbonne Université, Assistance Publique Hôpitaux de Paris, Pitié Salpêtrière Hospital, Paris, France.
Department of Rheumatology, Université St Etienne, and CRI-IMIDIATE Clinical Research Infrastructure Network, Paris, France.
出版信息
Clin Exp Rheumatol. 2023 Sep;41(9):1831-1837. doi: 10.55563/clinexprheumatol/eonoj3. Epub 2023 Jul 24.
OBJECTIVES
The aim was to evaluate the ability of baseline multi-biomarker disease activity (MBDA) score to discriminate between patients with rheumatoid arthritis (RA) in remission who are at high risk versus low risk of relapse after TNF-inhibitor (TNFi) tapering.
METHODS
The study is a post-hoc analysis of patients who completed the Spacing of TNFi injections in Rheumatoid ArthritiS Study (STRASS), a multicentre 18-month equivalence randomised controlled study, of TNFi tapering in RA patients in remission, and had baseline serum samples available for MBDA testing. The primary endpoint of this study was the ability of the baseline MBDA score to predict relapse at any time during the 18 months following initiation of TNFi tapering. Secondary endpoints were the ability of baseline MBDA score to predict TNFi discontinuation at Month 18, and structural damage progression on x-rays assessed by the change in total van der Heijde-modified Sharp score from baseline to month 18.
RESULTS
64 and 73 patients were included in the spacing (S)-arm and maintenance (M)-arm, respectively. In the M-arm, the mean MBDA score at baseline was higher among patients who relapsed during the 18-month follow-up than those who did not relapse: 32.5 compared to 27.2 (p=0.053) whereas no difference in the MBDA score was observed in the S-arm between patients who relapsed or not 27 compared to 26.2 (p=0.57) 13 patients (21.3%) of the S-arm were able to discontinue TNFi, for which the predictive value of the MBDA score was low (AUC=0.560). Radiographic progression in both arms, although low (n=9) was not correlated with the MBDA score at baseline with a poor discriminative value in both arms (AUC=0.558).
CONCLUSIONS
In our study MBDA score in baseline was not predictive of relapse, discontinuation of TNFi in patients with long-standing RA patients tapering TNFi.
目的
评估基线多生物标志物疾病活动（MBDA）评分在区分接受肿瘤坏死因子抑制剂（TNFi）减量治疗后处于缓解期的类风湿关节炎（RA）患者中高复发风险与低复发风险的能力。
方法
这是一项对完成间隔 TNFi 注射治疗类风湿关节炎研究（STRASS）的患者进行的事后分析，这是一项多中心、18 个月等效性随机对照研究，旨在评估 RA 缓解患者 TNFi 减量治疗，并且有基线血清样本可用于 MBDA 检测。本研究的主要终点是基线 MBDA 评分预测 TNFi 减量治疗开始后 18 个月内任何时间复发的能力。次要终点是基线 MBDA 评分预测第 18 个月时 TNFi 停药的能力，以及基线至第 18 个月时总 van der Heijde 改良 Sharp 评分变化评估的 X 射线结构损伤进展。
结果
分别有 64 名和 73 名患者纳入间隔（S）臂和维持（M）臂。在 M 臂中，在 18 个月随访期间复发的患者的基线 MBDA 评分高于未复发的患者：32.5 与 27.2（p=0.053），而 S 臂中复发或未复发的患者之间的 MBDA 评分无差异 27 与 26.2（p=0.57），S 臂中有 13 名患者（21.3%）能够停用 TNFi，MBDA 评分的预测值较低（AUC=0.560）。尽管两个臂的放射学进展都较低（n=9），但与基线时的 MBDA 评分无关，两个臂的区分值都较差（AUC=0.558）。
结论
在我们的研究中，基线 MBDA 评分不能预测缓解期长的 RA 患者 TNFi 减量治疗后复发或停用 TNFi。
Zotero 插件