PDF(Pubmed)
Abstract：
Background: Vedolizumab trough serum levels have been associated with clinical and endoscopic response in patients with inflammatory bowel disease (IBD). A recent study demonstrated that higher trough levels before dose escalation are associated with favorable outcomes. Objectives: We aimed to identify whether vedolizumab trough levels predict outcome of subsequent therapy. Methods: This retrospective study included IBD patients consecutively receiving vedolizumab therapy between November 2014 and June 2021. Only patients with a loss of response (LOR) to vedolizumab and available trough drug levels prior to therapy cessation were included. Clinical and endoscopic scores were recorded at 6 and 12 months post switching therapy. Results: Overall, 86 IBD patients (51 Crohn\'s disease, 35 ulcerative colitis) who discontinued vedolizumab were included; of those, 72 (83.7%) were due to LOR. Upon vedolizumab discontinuation, 66.3% of patients were switched to another biologic therapy. Trough vedolizumab levels at discontinuation due to LOR did not differ between patients with clinical response and LOR regarding subsequent therapy at 6 months [median 33.8 μg/mL (IQR 13.2-51.6) versus 31.7 μg/mL (IQR 9.1-64.8), p = 0.9] and at 12 months [median 29.6 μg/mL (IQR 14.3-51.6) versus 34.1 μg/mL (IQR 12.2-64.7), p = 0.6]. Patients progressing to subsequent surgery had numerically lower vedolizumab trough levels at LOR compared with patients who were treated with an additional medical therapy (median 14.3, IQR 4-28.2 μg/mL versus 33.5, IQR 13-51.6 μg/mL, p = 0.08). Conclusions: Vedolizumab trough levels upon LOR do not predict response to subsequent medical therapy; however, lower drug levels may suggest a more aggressive disease pattern and future need for surgery.
摘要：
背景：维多珠单抗谷血清水平与炎症性肠病（IBD）患者的临床和内镜反应相关。最近的一项研究表明，在剂量递增之前，较高的谷值水平与有利的结果有关。目标：我们旨在确定维多珠单抗谷水平是否能预测后续治疗的结果。方法：这项回顾性研究包括2014年11月至2021年6月期间连续接受维多珠单抗治疗的IBD患者。仅包括对维多珠单抗的反应丧失(LOR)和在治疗停止之前可用的谷值药物水平的患者。在转换治疗后6个月和12个月记录临床和内镜评分。结果：总体而言，86例IBD患者（51例克罗恩病，包括35名停用维多珠单抗的溃疡性结肠炎）；其中，72（83.7%）是由于LOR。维多珠单抗停药后，66.3%的患者改用其他生物治疗。在6个月的后续治疗方面，有临床反应的患者和有LOR的患者因LOR而停药时的Troughvedolizumab水平没有差异[中位数33.8μg/mL（IQR13.2-51.6）与31.7μg/mL（IQR9.1-64.8），p=0.9]和12个月时[中位数29.6μg/mL（IQR14.3-51.6）与34.1μg/mL（IQR12.2-64.7），p=0.6]。与接受其他药物治疗的患者相比，进行后续手术的患者在LOR时的维多珠单抗谷水平在数值上较低（中位数为14.3，IQR4-28.2μg/mL与33.5，IQR13-51.6μg/mL，p=0.08)。结论：LOR后的维多珠单抗谷水平不能预测对后续药物治疗的反应；然而，较低的药物水平可能表明疾病的侵袭性和未来需要手术治疗.
