Clinical Utility and Accuracy of Point-of-Care Testing for Anti-TNF Drug Monitoring and Loss of Response.

IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Christoph Teichert, Suzanne I Anjie, Toer W Stevens, Bayda Bahur, Kurtis R Bray, Krisztina B Gecse, Geert R D'Haens
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Abstract

Background and aims: Point-of-care tests (POCT) enable immediate measurement of anti-TNF blood concentrations. This study examined the association between loss of response (LOR) to infliximab (IFX) or adalimumab (ADL) and serum concentrations measured with POCT and enzyme-linked immunosorbent assay (ELISA) in inflammatory bowel disease (IBD) patients.

Methods: Patients with IBD with stored IFX or ADL serum samples were recruited. POCT was conducted, agreement with ELISA was evaluated using Bland-Altman plots. The primary endpoint was LOR defined as change in therapy, IBD-related surgery, new actively draining fistula, and/or endoscopic deterioration. ROC curves and quartile analysis assessed the association between concentrations and LOR.

Results: A total of 176 patients were included (92 IFX/84 ADL, 154 Crohn's disease, and 22 ulcerative colitis). Median follow-up time was 20 months (interquartile range 9-38). LOR occurred in 37/84 (44%) ADL users and 55/92 (60%) IFX users. Median serum concentrations were significantly lower in LOR patients compared with sustained response, measured by both techniques for ADL (POCT: 6.45 vs 13.48 µg/mL, P <.001; ELISA: 4.80 vs 8.80 µg/mL, P <.001) and IFX (POCT: 2.39 vs 6.50 µg/mL, P <.001; ELISA: 1.70 vs 4.40 µg/mL, P <.001). Quartile analysis revealed that higher serum concentrations were associated with maintained response. ROC curve analysis demonstrated good or excellent discrimination for POCT and ELISA in association with LOR (AUC IFX: POCT = 0.82, ELISA = 0.76; AUC ADL: POCT = 0.82, ELISA = 0.81; all P <.0001). An overestimation of serum concentrations with POCT was observed.

Conclusions: Serum ADL and IFX POCT concentrations are comparable to ELISA and associated with LOR, indicating its clinical utility.

抗肿瘤坏死因子药物监测和反应丧失的即时检测的临床效用和准确性。
背景和目的:点护理试验(POCT)可以立即测量抗tnf血药浓度。本研究探讨了炎症性肠病(IBD)患者对英夫利昔单抗(IFX)或阿达木单抗(ADL)的反应丧失(LOR)与POCT和酶联免疫吸附试验(ELISA)测定的血清浓度之间的关系。方法:招募有IFX或ADL血清样本的IBD患者。POCT进行,使用Bland-Altman图评估与ELISA的一致性。主要终点定义为治疗改变、ibd相关手术、新的主动引流瘘管和/或内窥镜恶化。ROC曲线和四分位数分析评估了浓度与LOR之间的关系。结果:共纳入176例患者(92例IFX/84例ADL, 154例克罗恩病,22例溃疡性结肠炎)。中位随访时间为20个月(四分位数范围9-38)。ADL使用者中有37/84(44%)和IFX使用者中有55/92(60%)发生LOR。与持续缓解相比,两种技术测量的ADL中位血清浓度显著低于LOR患者(POCT: 6.45 vs 13.48 μ g/mL)。结论:血清ADL和IFX POCT浓度与ELISA相当,并与LOR相关,表明其临床实用性。
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来源期刊
Inflammatory Bowel Diseases
Inflammatory Bowel Diseases 医学-胃肠肝病学
CiteScore
9.70
自引率
6.10%
发文量
462
审稿时长
1 months
期刊介绍: Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.
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