Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn's Disease.
Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn's Disease.
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DOI：
10.1053/j.gastro.2018.05.039
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发表时间：
2018-09
期刊：
影响因子：
29.4
通讯作者：
Cao C
中科院分区：
文献类型：
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作者：
Dulai PS;Boland BS;Singh S;Chaudrey K;Koliani-Pace JL;Kochhar G;Parikh MP;Shmidt E;Hartke J;Chilukuri P;Meserve J;Whitehead D;Hirten R;Winters AC;Katta LG;Peerani F;Narula N;Sultan K;Swaminath A;Bohm M;Lukin D;Hudesman D;Chang JT;Rivera-Nieves J;Jairath V;Zou GY;Feagan BG;Shen B;Siegel CA;Loftus EV Jr;Kane S;Sands BE;Colombel JF;Sandborn WJ;Lasch K;Cao C
随着炎症性肠病的治疗选择越来越多，重要的是要确定最有可能对不同疗法产生反应的患者。我们创建并验证了一个评分系统，以识别对Vedolizumab有应答的克罗恩病（CD）患者。我们收集了活动性CD患者接受Vedolizumab治疗26周（n=814）的GEMINI 2 III期试验的数据，并进行了logistic回归分析，以确定与临床、无类固醇和持久缓解相关的因素（推导集）。我们使用这些数据开发了一种临床决策支持工具，并使用来自接受Vedolizumab治疗26周的活动性CD患者的单独临床实践观察性队列（VICTORY队列）中366例受试者的数据进行了验证。我们使用受试者工作特征曲线下面积（AUC）分析，评价了该工具识别Vedolizumab治疗后临床缓解或无糖皮质激素缓解患者、粘膜愈合（MH）患者、MH临床缓解患者或MH无糖皮质激素缓解患者的能力。主要结局是在活动性CD患者中开发并验证与Vedolizumab治疗达到缓解相关的因素列表。在推导分析中，我们确定了既往无肿瘤坏死因子拮抗剂治疗（+3分），既往无肠道手术（+2分），既往无瘘管病（+2分），白蛋白基线水平（每克/升+0.4分），和C反应蛋白的基线浓度（3.0-10.0 mg/L之间的值降低0.5分，> 10.0 mg/L的值降低3.0分）作为缓解相关因素。在验证集中，我们的模型确定了AUC为0.67的临床缓解患者、AUC为0.66的无皮质类固醇缓解患者、AUC为0.72的MH患者、AUC为0.73的MH临床缓解患者和AUC为0.75的无皮质类固醇临床缓解患者。13分的临界值确定Vedolizumab治疗后达到临床缓解的患者的敏感性为92%，无糖皮质激素缓解的患者的敏感性为94%，MH患者的敏感性为98%，深度缓解的患者的敏感性为100%，无糖皮质激素临床缓解的MH患者的敏感性为100%。我们开发并验证了一种评分系统，以确定最有可能对26周Vedolizumab治疗产生应答的CD患者。需要进一步研究以优化其在选择人群中的准确性并确定其成本效益。
As more treatment options for inflammatory bowel diseases become available, it is important to identify patients most likely to respond to different therapies. We created and validated a scoring system to identify patients with Crohn’s disease (CD) who respond to vedolizumab. We collected data from GEMINI 2 phase 3 trial of patients with active CD treated with vedolizumab for 26 weeks (n=814) and performed logistic regression analysis to identify factors associated with clinical, steroid-free, and durable remission (derivation set). We used these data to develop a clinical decision support tool, which we validated using data from 366 participants in a separate clinical practice observational cohort of patients with active CD treated with vedolizumab for 26 weeks (the VICTORY cohort). We evaluated the ability of this tool to identify patients in clinical remission or corticosteroid-free remission, or those with mucosal healing (MH), clinical remission with MH, or corticosteroid-free remission with MH after vedolizumab therapy using receiver operating characteristic area under the curve (AUC) analyses. The primary outcome was to develop and validate a list of factors associated with achieving remission by vedolizumab in patients with active CD. In the derivation analysis, we identified absence of previous treatment with a tumor necrosis factor antagonist (+3 points), absence of prior bowel surgery (+2 points), absence of prior fistulizing disease (+2 points), baseline level of albumin (+0.4 points per g/L), and baseline concentration of C-reactive protein (reduction of 0.5 points for values between 3.0–10.0 mg/L and 3.0 points for values > 10.0 mg/L) as factors associated with remission. In the validation set, our model identified patients in clinical remission with an AUC of 0.67, patients in corticosteroid-free remission with an AUC of 0.66, patients with MH with an AUC of 0.72, patients in clinical remission with MH with an AUC of 0.73, and patients in corticosteroid-free clinical remission with MH with an AUC of 0.75. A cut-off value of 13 points identified patients in clinical remission after vedolizumab therapy with 92% sensitivity, patients in corticosteroid-free remission with 94% sensitivity, patients with MH with 98% sensitivity, patients in deep remission with 100% sensitivity, and patients with corticosteroid-free clinical remission with MH with 100% sensitivity. We developed and validated a scoring system to identify patients with CD most likely to respond to 26 weeks of vedolizumab therapy. Further studies are needed to optimize its accuracy in select populations and determine its cost effectiveness.
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