Magro Fernando, Afonso Joana, Lopes Susana, Coelho Rosa, Gonçalves Raquel, Caldeira Paulo, Lago Paula, de Sousa Helena Tavares, Ramos Jaime, Gonçalves Ana Rita, Ministro Paula, Rosa Isadora, Meira Tânia, Andrade Patrícia, Soares João-Bruno, Carvalho Diana, Sousa Paula, Vieira Ana Isabel, Lopes Joanne, Dias Cláudia Camila, Geboes Karel, Carneiro Fátima
Department of Biomedicine, Unity of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal.
Department of Biomedicine, Unity of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal MedInUP, Centre for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal.
Therap Adv Gastroenterol. 2017 Sep;10(9):651-660. doi: 10.1177/1756283X17722916. Epub 2017 Aug 11.
Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective.
This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit.
Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman's rank correlation coefficient = 0.843, < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791-0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 µg/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 µg/ml was 88% both for a Mayo endoscopic score ⩽ 1 and for an FC concentration <250 µg/g.
Based on this study, we concluded that using the rapid IFX assessment system with a 3 µg/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.
基于治疗药物监测（TDM）的算法可用于指导炎症性肠病（IBD）患者的英夫利昔单抗（IFX）调整。本研究旨在从临床角度探索一种快速的IFX定量检测方法。
本手稿描述了一项前瞻性队列研究，纳入了110例处于IFX维持治疗阶段的溃疡性结肠炎（UC）患者。使用快速定量检测法和常用的参考试剂盒对IFX谷浓度进行定量。
无论采用何种检测方法来测量IFX，其谷浓度在有内镜缓解（梅奥内镜评分=0）和无内镜缓解的患者之间，以及根据粪便钙卫蛋白（FC）水平分层的患者之间均存在统计学差异。尽管两种方法之间具有良好的相关性[Spearman等级相关系数=0.843，P<0.001；组内相关系数=0.857，95%置信区间（CI）：0.791-0.903]，但仍存在明显的系统差异；参考试剂盒获得的值平均比快速检测法获得的值高2.62个单位。尽管如此，3μg/ml被证明是使用两种检测方法评估内镜状态和炎症负担水平的可接受临界值。当快速检测法测得的IFX浓度高于3μg/ml时，梅奥内镜评分⩽1以及FC浓度<250μg/g的患者中预后良好的比例均为88%。
基于本研究，我们得出结论，对于处于IFX维持治疗阶段的患者，使用阈值为3μg/ml的快速IFX评估系统是耗时的酶联免疫吸附测定的可靠替代方法。
