Anke L. Nguyen MBBS, FRACP, Peter R. Gibson MBBS, FRACP, PhD, Richard N. Upton PhD, Diane R. Mould PhD, Miles P. Sparrow MBBS, FRACP, DMedSc
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Net drug use and costs were evaluated. A total of 174 patients—56% men; median age, 36 (interquartile range, 29-47) years; 135 with Crohn disease; and 31 with ulcerative colitis—were included, with 417 dose X recordings. Median prior infliximab therapy was 2 (0-4) years. Comparing actual dose X with predicted dose X, 52% and 32% of doses were subtherapeutic when aiming for trough concentrations of 5-10 and 3-7 μg/mL, respectively. Treatment costs increased by 102% and 29% for the 2 trough ranges, respectively. On multivariate regression analysis, subtherapeutic infliximab concentrations were associated with ulcerative colitis compared with Crohn disease (odds ratio, 9.81; 95% confidence interval, 1.28-75.40; <i>P</i> = .028) and predose X infliximab trough concentration [odds ratio, 0.07; 95% confidence interval, 0.03-0.15; <i>P</i> < .001]. Over half of maintenance infliximab drug doses were too low to achieve infliximab blood concentrations of 5 μg/mL or greater. 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引用次数: 0
摘要
精确给药模型预测英夫利昔单抗剂量在炎症性肠病(IBD)患者中达到目标谷浓度。这些模型已被证明可以减少无反应并改善患者的预后。我们比较了iDOSE®精确给药和标准给药确定的英夫利昔单抗剂量,以及IBD患者的相关药物成本。在这项回顾性研究中,IBD患者每8周接受5 mg/kg剂量的英夫利昔单抗治疗。如果记录了以前的三次英夫利昔单抗剂量、实验室值(包括英夫利昔单抗谷浓度和患者体重),则将一次英夫利昔单抗剂量命名为剂量X。将实际剂量X与iDOSE®预测剂量X进行比较。评估净药物使用和成本。174例患者,56%为男性,中位年龄36岁(IQR 29-47);135例克罗恩病和31例溃疡性结肠炎纳入了417次剂量X记录。先前英夫利昔单抗治疗的中位时间为2(0-4)年。将实际剂量X与预测剂量X进行比较,目标谷浓度分别为5-10 μg/ml和3-7 μg/ml时,52%和32%的剂量为亚治疗性剂量。两个波谷范围的治疗费用分别增加了102%和29%。在多因素回归分析中,与克罗恩病相比,亚治疗期英夫利昔单抗浓度与溃疡性结肠炎相关[OR: 9.81, 95% CI: 1.28-75.40, p = 0.028],而剂量前英夫利昔单抗谷浓度[OR: 0.07, 95% CI: 0.03-0.15, p = 0.028]
Application of a Precision-Dosing Model to a Real-World Cohort of Patients on Infliximab Maintenance Therapy: Drug Usage and Cost Analysis
Precision-dosing models forecast infliximab doses to achieve targeted trough concentrations in patients with inflammatory bowel disease (IBD). These models have shown to reduce nonresponse and improve patient outcomes. We compared infliximab doses determined by iDOSE precision dosing with standard dosing, and the associated drug costs, in patients with IBD. In this retrospective study, patients with IBD treated with infliximab every 8 weeks at 5 mg/kg were included. An infliximab dose was named dose X if 3 previous infliximab doses, laboratory values including trough infliximab concentrations, and the patient's weight were recorded. The actual dose X was compared to an iDOSE-predicted dose X. Net drug use and costs were evaluated. A total of 174 patients—56% men; median age, 36 (interquartile range, 29-47) years; 135 with Crohn disease; and 31 with ulcerative colitis—were included, with 417 dose X recordings. Median prior infliximab therapy was 2 (0-4) years. Comparing actual dose X with predicted dose X, 52% and 32% of doses were subtherapeutic when aiming for trough concentrations of 5-10 and 3-7 μg/mL, respectively. Treatment costs increased by 102% and 29% for the 2 trough ranges, respectively. On multivariate regression analysis, subtherapeutic infliximab concentrations were associated with ulcerative colitis compared with Crohn disease (odds ratio, 9.81; 95% confidence interval, 1.28-75.40; P = .028) and predose X infliximab trough concentration [odds ratio, 0.07; 95% confidence interval, 0.03-0.15; P < .001]. Over half of maintenance infliximab drug doses were too low to achieve infliximab blood concentrations of 5 μg/mL or greater. While applying precision dosing may improve patient outcomes, drug costs could be considerably greater.