Department of Biochemistry, P. D. Hinduja Hospital & MRC, Veer Savarkar Marg, Mahim, Mumbai, 400016, India.
Department of Gastroenterology, P. D. Hinduja Hospital & MRC, Veer Savarkar Marg, Mahim, Mumbai, 400016, India.
Eur J Clin Pharmacol. 2021 Jan;77(1):55-62. doi: 10.1007/s00228-020-02975-0. Epub 2020 Aug 15.
Infliximab (IFX) therapy in inflammatory bowel disease (IBD) is associated with loss of response in half the patients, due to complex pharmacokinetic and immunological factors. Dashboard's Bayesian algorithms use information from model and individual multivariate determinants of IFX concentration and can predict dose and dosing interval.
To compare measured IFX concentrations in our laboratory with values predicted by iDose dashboard system and report its efficacy in managing patients not responding to conventional dosing schedule.
Clinical history, demographic details, and laboratory findings such as albumin and C-reactive protein (CRP) data of IBD patients (n = 30; median age 23 years (IQR: 14.25 - 33.5)) referred for IFX drug monitoring in our laboratory from November 2017 to November 2019 were entered in iDose software. The IFX concentration predicted by iDose based on this information was compared with that measured in our laboratory. In addition, a prospective dashboard-guided dosing was prescribed in 11 of these 30 patients not responding to conventional dosing and was followed to assess their clinical outcome.
IFX monitoring in our 30 patients had shown therapeutic concentration in 12, supratherapeutic in 2 and subtherapeutic concentration in 16 patients. The iDose predicted concentration showed concordance in 21 of these 30 patients. Of 11 patients managed with iDose-assisted prospective dosing, 8 achieved clinical remission, 2 showed partial response, and one developed antibodies.
Retrospective data analysis showed concordance between laboratory measured and iDose-predicted IFX level in 70% of patients. iDose-assisted management achieved clinical remission and cost reduction.
英夫利昔单抗（IFX）治疗炎症性肠病（IBD），约有一半的患者会因复杂的药代动力学和免疫因素而失去应答。Dashboard 的贝叶斯算法利用模型和 IFX 浓度个体多变量决定因素的信息，可以预测剂量和给药间隔。
比较我们实验室测量的 IFX 浓度与 iDose 仪表盘系统预测的值，并报告其在管理对常规给药方案无应答的患者方面的疗效。
将 2017 年 11 月至 2019 年 11 月在我们实验室进行 IFX 药物监测的 IBD 患者（n=30；中位年龄 23 岁（IQR：14.25-33.5））的临床病史、人口统计学细节和实验室结果（如白蛋白和 C 反应蛋白（CRP）数据）输入到 iDose 软件中。根据这些信息，iDose 预测的 IFX 浓度与我们实验室测量的浓度进行比较。此外，对 30 名患者中的 11 名未对常规剂量做出反应的患者进行了前瞻性的基于仪表盘的剂量调整，并进行了随访以评估其临床结果。
在我们的 30 名患者中，IFX 监测显示 12 名患者的治疗浓度，2 名患者的超治疗浓度，16 名患者的治疗浓度。iDose 预测的浓度在这 30 名患者中的 21 名患者中具有一致性。在接受 iDose 辅助前瞻性剂量调整的 11 名患者中，8 名患者达到临床缓解，2 名患者部分缓解，1 名患者产生抗体。
回顾性数据分析显示，实验室测量值与 iDose 预测的 IFX 水平在 70%的患者中具有一致性。iDose 辅助管理可实现临床缓解和降低成本。
