美国多生物标志物疾病活动检测的应用和临床实用性。
Uptake and Clinical Utility of Multibiomarker Disease Activity Testing in the United States.
机构信息
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham.
出版信息
J Rheumatol. 2019 Mar;46(3):237-244. doi: 10.3899/jrheum.180071. Epub 2018 Nov 15.
OBJECTIVE
The clinical utility of the multibiomarker disease activity (MBDA) test for rheumatoid arthritis (RA) management in routine care in the United States has not been thoroughly studied.
METHODS
Using 2011-2015 Medicare data, we linked each patient with RA to their MBDA test result. Initiation of a biologic or Janus kinase (JAK) inhibitor in the 6 months following MBDA testing was described. Multivariable adjustment evaluated the likelihood of adding or switching biologic/JAK inhibitor, controlling for potential confounders. For patients with high MBDA scores who added a new RA therapy and were subsequently retested, lack of improvement in the MBDA score was evaluated as a predictor of future RA medication failure, defined by the necessity to change RA medications again.
RESULTS
Among 60,596 RA patients with MBDA testing, the proportion adding or switching biologics/JAK inhibitor among those not already taking a biologic/JAK inhibitor was 9.0% (low MBDA), 11.8% (moderate MBDA), and 19.7% (high MBDA, p < 0.0001). Similarly, among those already taking biologics/JAK inhibitor, the proportions were 5.2%, 8.3%, and 13.5% (p < 0.0001). After multivariable adjustment, referent to those with low disease MBDA scores, the likelihood of switching was 1.51-fold greater (95% CI 1.35-1.69) for patients with moderate MBDA scores, and 2.62 (2.26-3.05) for patients with high MBDA scores. Among those with high MBDA scores who subsequently added a biologic/JAK inhibitor and were retested, lack of improvement in the MBDA score category was associated with likelihood of future RA treatment failure (OR 1.61, 95% CI 1.27-2.03).
CONCLUSION
The MBDA score was associated with both biologic and JAK inhibitor medication addition/switching and subsequent treatment outcomes.
目的
尚未深入研究多生物标志物疾病活动（MBDA）检测在 美国常规护理中对类风湿关节炎（RA）管理的临床实用性。
方法
使用 2011-2015 年 Medicare 数据，我们将每位 RA 患者与其 MBDA 检测结果相关联。描述了在 MBDA 检测后 6 个月内开始使用生物制剂或 Janus 激酶（JAK）抑制剂的情况。多变量调整评估了添加或切换生物制剂/JAK 抑制剂的可能性，同时控制了潜在的混杂因素。对于添加新的 RA 治疗且随后再次进行 MBDA 检测的高 MBDA 评分患者，评估 MBDA 评分无改善作为未来 RA 药物治疗失败的预测指标，定义为再次改变 RA 药物治疗的必要性。
结果
在 60596 例接受 MBDA 检测的 RA 患者中，未接受生物制剂/JAK 抑制剂治疗的患者中添加或切换生物制剂/JAK 抑制剂的比例分别为 9.0%（低 MBDA）、11.8%（中 MBDA）和 19.7%（高 MBDA，p < 0.0001）。同样，在已经接受生物制剂/JAK 抑制剂治疗的患者中，这些比例分别为 5.2%、8.3%和 13.5%（p < 0.0001）。经过多变量调整后，与低疾病 MBDA 评分的患者相比，中 MBDA 评分患者的切换可能性增加 1.51 倍（95%CI 1.35-1.69），高 MBDA 评分患者增加 2.62 倍（2.26-3.05）。在随后添加生物制剂/JAK 抑制剂并再次进行 MBDA 检测的高 MBDA 评分患者中，MBDA 评分类别的无改善与未来 RA 治疗失败的可能性相关（OR 1.61，95%CI 1.27-2.03）。
结论
MBDA 评分与生物制剂和 JAK 抑制剂的药物添加/切换以及随后的治疗结果均相关。
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