INSERM U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.
Department of Hepato-Gastroenterology, University Hospital of Saint-Etienne, Saint-Etienne, France.
Aliment Pharmacol Ther. 2018 Apr;47(7):906-912. doi: 10.1111/apt.14548. Epub 2018 Jan 31.
The correlation between vedolizumab trough levels during induction therapy and mucosal healing remains unknown.
To compare early vedolizumab trough levels in patients with and without mucosal healing within the first year after treatment initiation.
We prospectively collected vedolizumab trough levels in all inflammatory bowel disease patients at weeks 2, 6 and 14 of vedolizumab treatment in three French referral centres between 1 June 2014 and 31 March 2017. Results of every patient that underwent mucosal assessment by magnetic resonance imaging and/or endoscopy in the first year after treatment initiation were analysed.
Median vedolizumab trough levels in the overall population (n = 82) were 27 μg/mL (interquartile range, IQR 21.2-33.8 μg/mL) at week 2, 23 μg/mL (IQR 15-34.5 μg/mL) at week 6 and 10.7 μg/mL (IQR 4.6-20.4 μg/mL) at week 14. Only median vedolizumab trough levels at week 6 differed between patients with and without mucosal healing within the first year after treatment initiation (26.8 vs 15.1 μg/mL, P = 0.035). A cut-off trough level of 18 μg/mL at week 6 predicted mucosal healing within the first year after the start of vedolizumab with an area under the receiver operating curve of 0.735 (95% confidence interval 0.531-0.939). A vedolizumab trough level above 18 μg/mL at week 6 was the only independent variable associated with mucosal healing within the first year of treatment (odds ratio 15.7, 95% confidence interval 2.4-173.0, P = 0.01).
Early therapeutic drug monitoring might improve timely detection of vedolizumab-treated patients in need for an intensified dosing regimen.
诱导治疗期间维得利珠单抗谷浓度与黏膜愈合之间的相关性尚不清楚。
比较治疗开始后 1 年内黏膜愈合患者和未愈合患者早期维得利珠单抗谷浓度。
我们前瞻性收集了 2014 年 6 月 1 日至 2017 年 3 月 31 日期间法国 3 个转诊中心的所有炎症性肠病患者接受维得利珠单抗治疗第 2、6 和 14 周时的维得利珠单抗谷浓度。分析了治疗开始后 1 年内所有接受磁共振成像和/或内镜黏膜评估的患者的结果。
总体人群（n=82）的中位维得利珠单抗谷浓度在第 2 周时为 27μg/mL（四分位距，IQR 21.2-33.8μg/mL），第 6 周时为 23μg/mL（IQR 15-34.5μg/mL），第 14 周时为 10.7μg/mL（IQR 4.6-20.4μg/mL）。只有治疗开始后 1 年内黏膜愈合患者的第 6 周维得利珠单抗谷浓度与未愈合患者不同（26.8 与 15.1μg/mL，P=0.035）。第 6 周谷浓度 18μg/mL 预测治疗开始后 1 年内黏膜愈合的曲线下面积为 0.735（95%置信区间 0.531-0.939）。第 6 周时维得利珠单抗谷浓度高于 18μg/mL 是治疗开始后 1 年内黏膜愈合的唯一独立相关变量（比值比 15.7，95%置信区间 2.4-173.0，P=0.01）。
早期治疗药物监测可能有助于及时发现需要强化给药方案的维得利珠单抗治疗患者。
