The Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Medical College of Wisconsin, Madison, WI, USA.
J Crohns Colitis. 2019 Aug 14;13(8):963-969. doi: 10.1093/ecco-jcc/jjz041.
Vedolizumab is an anti-α4β7 biologic approved for ulcerative colitis [UC] and Crohn's disease [CD]. We aimed to examine the association of maintenance vedolizumab concentrations with remission.
We performed a cross-sectional multi-centre study of inflammatory bowel disease [IBD] patients on maintenance vedolizumab. A homogeneous mobility shift assay [HMSA] was used to determine trough serum concentrations of vedolizumab and anti-drug antibodies [ATVs]. The primary outcome was corticosteroid-free clinical and biochemical remission defined as a composite of clinical remission, normalized C-reactive protein [CRP] and no corticosteroid use in 4 weeks. Secondary outcomes included corticosteroid-free endoscopic and deep remission. Vedolizumab concentrations were compared between patients in remission and with active disease. Logistic regression, adjusting for confounders, assessed the association between concentrations and remission.
In total, 258 IBD patients were included [55% CD and 45% UC]. Patients in clinical and biochemical remission had significantly higher vedolizumab concentrations [12.7 µg/mL vs 10.1 µg/mL, p = 0.002]. Concentrations were also higher among patients in endoscopic and deep remission [14.2 µg/mL vs 8.5 µg/mL, p = 0.003 and 14.8 µg/mL vs 10.1 µg/mL, p = 0.01, respectively]. After controlling for potential confounders, IBD patients with vedolizumab concentrations >11.5 µg/mL were nearly 2.4 times more likely to be in corticosteroid-free clinical and biochemical remission. Only 1.6% of patients had ATVs.
In a large real-world cohort of vedolizumab maintenance concentrations, IBD patients with remission defined by objective measures [CRP and endoscopy] had significantly higher trough vedolizumab concentrations and immunogenicity was uncommon.
维得利珠单抗是一种抗 α4β7 的生物制剂，已被批准用于溃疡性结肠炎[UC]和克罗恩病[CD]。我们旨在研究维持维得利珠单抗浓度与缓解之间的关联。
我们对接受维持维得利珠单抗治疗的炎症性肠病[IBD]患者进行了一项横断面多中心研究。使用均一流动位移分析[HMSA]测定维得利珠单抗和抗药物抗体[ATV]的谷浓度。主要结局是无皮质类固醇的临床和生化缓解，定义为临床缓解、C 反应蛋白[CRP]正常和 4 周内无皮质类固醇使用的综合指标。次要结局包括无皮质类固醇的内镜和深度缓解。比较缓解患者和活动期疾病患者的维得利珠单抗浓度。调整混杂因素后，逻辑回归评估浓度与缓解之间的关系。
共纳入 258 例 IBD 患者[55% CD 和 45% UC]。临床和生化缓解患者的维得利珠单抗浓度明显更高[12.7µg/mL 比 10.1µg/mL，p=0.002]。内镜和深度缓解患者的浓度也更高[14.2µg/mL 比 8.5µg/mL，p=0.003 和 14.8µg/mL 比 10.1µg/mL，p=0.01]。在控制潜在混杂因素后，维得利珠单抗浓度>11.5µg/mL 的 IBD 患者达到无皮质类固醇的临床和生化缓解的可能性几乎增加了 2.4 倍。仅有 1.6%的患者存在 ATVs。
在维得利珠单抗维持浓度的大型真实世界队列中，通过客观指标[CRP 和内镜]定义的缓解患者的谷维得利珠单抗浓度明显更高，免疫原性并不常见。
