Prometheus Laboratories Inc, 9410 Carroll Park Dr, San Diego, CA 92121. Email:
Am J Manag Care. 2023 Oct;29(12 Suppl):S227-S235. doi: 10.37765/ajmc.2023.89447.
Evaluate the clinical utility of a precision-guided dosing test for infliximab (IFX) and its impact on treatment decision-making for inflammatory bowel disease (IBD).
Prospective, multisite, clinical experience program.
Health care providers were given access to PredictrPK IFX, a precision-guided dosing test, for their patients with IBD on maintenance IFX therapy. Blood samples were drawn 20 to 56 days post infusion. A Bayesian data assimilation tool used clinical and serologic data to generate individual pharmacokinetic profiles and forecast trough IFX. Results were reported to providers to aid in-therapy management decisions and the decision-making process was assessed through questionnaires. Relationships between forecasted IFX concentration, disease activity, and therapy management decisions were analyzed by logistic regression.
PredictrPK IFX was used for 275 patients with IBD by 37 providers. In 58% of cases, providers modified treatment plans based on the results, including dose modifications (41%; of these, one-third decreased dose) and discontinuation (8%) of IFX. Of the 42% where treatment was not modified, 97.5% had IFX levels of 5 µg/mL or greater. Patients with IFX concentrations less than 5 µg/mL were 3 and 7.3 times more likely to have active disease or discontinue IFX, respectively. There was unanimous agreement among providers who completed a postprogram survey that PredictrPK IFX was beneficial in guiding treatment decisions and added more value to their practice than routine therapeutic drug monitoring.
PredictrPK IFX enables earlier and more precise dose optimization of IFX in patients with IBD, exerting a substantial impact on treatment decisions that may result in improved health outcomes and overall cost savings.
评估英夫利昔单抗（IFX）精准指导剂量检测的临床实用性及其对炎症性肠病（IBD）治疗决策的影响。
前瞻性、多中心、临床经验计划。
为接受 IFX 维持治疗的 IBD 患者提供精准指导剂量检测PredictrPK IFX。在输注后 20 至 56 天采集血样。贝叶斯数据同化工具利用临床和血清学数据生成个体药代动力学曲线并预测 IFX 谷浓度。结果报告给提供者以辅助治疗管理决策，并通过问卷调查评估决策过程。通过逻辑回归分析预测 IFX 浓度、疾病活动度与治疗管理决策之间的关系。
37 名提供者共为 275 名 IBD 患者使用了 PredictrPK IFX。在 58%的情况下，提供者根据结果修改了治疗计划，包括剂量调整（41%；其中三分之一减少剂量）和 IFX 停药（8%）。在未修改治疗方案的 42%的患者中，97.5%的 IFX 水平为 5µg/mL 或更高。IFX 浓度低于 5µg/mL 的患者发生疾病活动或停止 IFX 的可能性分别增加 3 倍和 7.3 倍。完成方案后调查的提供者一致认为，PredictrPK IFX 有助于指导治疗决策，为他们的实践增加了比常规治疗药物监测更多的价值。
PredictrPK IFX 使 IBD 患者的 IFX 更早、更精确地优化剂量，对治疗决策产生重大影响，可能改善健康结果并节省总体成本。
