PDF(Pubmed)
Abstract：
In this study, plasma belimumab concentrations were measured over the course of treatment in systemic lupus erythematosus (SLE) patients on belimumab therapy, and intra- and interindividual variations in plasma belimumab concentration were evaluated. A single-center prospective study was conducted at Oita University Hospital to evaluate trough plasma concentrations over the course of treatment in 13 SLE patients treated with intravenous belimumab. Plasma belimumab concentrations were measured by a validated ultra-high performance liquid chromatography with tandem mass spectrometry method. The median age of the patients was 40 (interquartile range: 35-51) years and the median weight was 51.8 (47.0-58.1) kg. A mean of 9.4 (range: 1-13) blood samples was collected per patient at routine visits. The mean (± SD) plasma belimumab concentration was 33.4 ± 11.9 μg/mL in the patient with the lowest concentration and 170.0 ± 16.6 μg/mL in the patient with the highest concentration, indicating a 5-fold difference between patients. On the other hand, the within-patient coefficient of variation ranged from 7.1% to 35.7%, showing no large variations. No significant correlation was observed between plasma belimumab concentration and belimumab dose (mg/kg) (Spearman\'s rank correlation coefficient = 0.22, p = .54). Examinations of trough plasma belimumab concentrations over the course of treatment in patients with SLE showed small intraindividual variation but large interindividual variation. Plasma belimumab trough concentration varied widely among patients administered the approved dose.
摘要：
在这项研究中,在接受贝利木单抗治疗的系统性红斑狼疮（SLE）患者的治疗过程中测量血浆贝利木单抗浓度，并评估血浆贝利木单抗浓度的个体内和个体间变化.在大分大学医院进行了一项单中心前瞻性研究，以评估13例接受静脉注射贝利木单抗治疗的SLE患者在治疗过程中的血浆浓度。通过验证的超高效液相色谱-串联质谱方法测量血浆贝利木单抗浓度。患者的中位年龄为40（四分位距：35-51）岁，中位体重为51.8（47.0-58.1）kg。在常规就诊时,每位患者平均收集9.4(范围:1-13)个血样。最低浓度患者的平均（±SD）血浆贝利木单抗浓度为33.4±11.9μg/mL，最高浓度患者为170.0±16.6μg/mL，表明患者之间有5倍的差异。另一方面,患者内部变异系数在7.1%至35.7%之间，没有大的变化。在血浆贝利木单抗浓度和贝利木单抗剂量(mg/kg)之间没有观察到显著的相关性(Spearman的等级相关系数=0.22,p=.54)。SLE患者在治疗过程中对血浆belimumab浓度的谷值检查显示，个体内变化小，但个体间变化大。血浆贝利木单抗谷浓度在施用批准剂量的患者中差异很大。
