Chaemsupaphan Thanaboon, Pudipeddi Aviv, Lin Huiyu, Paramsothy Sudarshan, Kariyawasam Viraj, Kermeen Melissa, Leong Rupert W
Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
Division of Gastroenterology, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Crohns Colitis 360. 2024 Dec 28;7(1):otae068. doi: 10.1093/crocol/otae068. eCollection 2025 Jan.
Vedolizumab is s gut-selective advanced therapy that is safe and efficacious for the treatment of ulcerative colitis (UC). Once patients achieve successful induction, there is a risk of loss of response leading to eventual flare. We aimed to identify these predictive factors and develop a practical scoring system to determine the ongoing efficacy of vedolizumab.
We performed logistic regression on prospectively recruited UC subjects from the Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS). All patients were in corticosteroid-free clinical remission and endoscopic improvement at baseline and continued vedolizumab. Predictive factors of 2-year corticosteroid-free clinical remission were determined and modeled into the VIEWS score, then validated in a real-world UC cohort.
Of 62 patients in the derivation cohort, 48 (77.4%) maintained clinical remission over two years. The predictive factors of remission were female (odds ratio [OR] 6.0, 95% confidence interval [CI], 1.2-29.7), antitumor necrosis factor naive (OR 3.8, 95% CI,1.0-14.0), baseline histological remission (OR 10.8, 95% CI, 2.4-48.4), thiopurine combination (OR 3.6, 95% CI, 0.7-18.0), and fecal calprotectin level ≤250 µg/g (OR 6.3, 95% CI, 0.9-42.2). These factors were incorporated into VIEWS score, yielding an area under the receiver-operating characteristic (AUROC) curve of 0.89 (95% CI, 0.81-0.98) in the prediction of 2-year clinical remission. Of 64 UC patients in the validation cohort, 40 (62.5%) remained in clinical remission at 2 years with AUROC of 0.77 (95% CI, 0.60-0.94). At the cut-off threshold of 4, the VIEWS score identified 2-year clinical remission with a sensitivity of 88.4% and specificity of 63.6%.
Our study determined predictive factors and proposed a scoring system of ongoing clinical remission in UC patients on maintenance vedolizumab. In patients at high risk of relapse, combination therapy with thiopurine may be beneficial.
维多珠单抗是一种肠道选择性的先进疗法，对溃疡性结肠炎（UC）的治疗安全有效。一旦患者成功诱导缓解，就存在失去反应导致最终病情复发的风险。我们旨在确定这些预测因素，并开发一种实用的评分系统来确定维多珠单抗的持续疗效。
我们对来自维多珠单抗免疫调节剂强制撤药研究（VIEWS）中前瞻性招募的UC受试者进行了逻辑回归分析。所有患者在基线时均处于无皮质类固醇的临床缓解和内镜改善状态，并继续使用维多珠单抗。确定了无皮质类固醇2年临床缓解的预测因素，并将其纳入VIEWS评分模型，然后在一个真实世界的UC队列中进行验证。
在推导队列的62例患者中，48例（77.4%）维持两年临床缓解。缓解的预测因素包括女性（比值比[OR]6.0，95%置信区间[CI]，1.2 - 29.7）、未使用过抗肿瘤坏死因子药物（OR 3.8，95% CI，1.0 - 14.0）、基线组织学缓解（OR 10.8，95% CI，2.4 - 48.4）、硫嘌呤联合使用（OR 3.6，95% CI，0.7 - 18.0）以及粪便钙卫蛋白水平≤250 µg/g（OR 6.3，95% CI，0.9 - 42.2）。这些因素被纳入VIEWS评分，在预测2年临床缓解时，受试者工作特征曲线（AUROC）下面积为0.89（95% CI，0.81 - 0.98）。在验证队列的64例UC患者中，40例（62.5%）在2年时仍处于临床缓解，AUROC为0.77（95% CI，0.60 - 0.94）。在截断阈值为4时，VIEWS评分识别2年临床缓解的敏感性为88.4%，特异性为63.6%。
我们的研究确定了预测因素，并提出了UC患者在维持使用维多珠单抗时持续临床缓解的评分系统。对于复发风险高的患者，硫嘌呤联合治疗可能有益。
