Narula Neeraj, Wong Emily C L, Colombel Jean-Frederic, Sandborn William J, Marshall John Kenneth, Daperno Marco, Reinisch Walter, Dulai Parambir S
Department of Medicine (Division of Gastroenterology), McMaster University, Hamilton, Ontario, Canada
Department of Medicine (Division of Gastroenterology), McMaster University, Hamilton, Ontario, Canada.
Gut. 2022 Jun;71(6):1078-1087. doi: 10.1136/gutjnl-2020-323799. Epub 2021 Mar 25.
The Simple Endoscopic Score for Crohn's disease (SES-CD) is the primary tool for measurement of mucosal inflammation in clinical trials but lacks prognostic potential. We set to develop and validate a modified multiplier of the SES-CD (MM-SES-CD), which takes into consideration each individual parameter's prognostic value for achieving endoscopic remission (ER) while on active therapy.
In this posthoc analysis of three CD clinical trial programmes (n=350 patients, baseline SES-CD ≥ 3 with confirmed ulceration), data were pooled and randomly split into a 70% training and 30% testing cohort. The MM-SES-CD was designed using weights for individual parameters as determined by logistic regression modelling, with 1-year ER (SES-CD < 3) being the dependent variable. A cut point score for low and high probability of ER was determined by using the maximum Youden Index and validated in the testing cohort.
Baseline ulcer size, extent of ulceration and presence of non-passable strictures had the strongest association with 1-year ER as compared with affected surface area, with differential weighting of individual parameters across disease segments being observed during logistic regression. The MM-SES-CD was generated using this weighted regression model and demonstrated strong discrimination for ER in the training dataset (area under the receiver operator curve (AUC) 0.83, 95% CI 0.78 to 0.94) and in the testing dataset (AUC 0.82, 95% CI 0.77 to 0.92). In comparison to the MM-SES-CD scoring model, the original SES-CD score lacks accuracy (AUC 0.60, 95% CI 0.55 to 0.65) for predicting the achievement of ER.
We developed and internally validated the MM-SES-CD as an endoscopic severity assessment tool to predict one-year ER in patients with CD on active therapy.
克罗恩病简易内镜评分（SES-CD）是临床试验中测量黏膜炎症的主要工具，但缺乏预后评估潜力。我们旨在开发并验证一种改良的SES-CD乘数（MM-SES-CD），该乘数在积极治疗期间考虑了每个个体参数对于实现内镜缓解（ER）的预后价值。
在对三项克罗恩病临床试验项目进行的事后分析中（n = 350例患者，基线SES-CD≥3且有确诊溃疡），将数据汇总并随机分为70%的训练队列和30%的测试队列。MM-SES-CD通过逻辑回归模型确定的个体参数权重进行设计，以1年ER（SES-CD < 3）作为因变量。通过使用最大约登指数确定ER低概率和高概率的切点分数，并在测试队列中进行验证。
与受累表面积相比，基线溃疡大小、溃疡范围和不可通过的狭窄的存在与1年ER的关联最强，在逻辑回归过程中观察到各疾病节段个体参数的加权差异。使用该加权回归模型生成了MM-SES-CD，其在训练数据集（受试者操作特征曲线下面积（AUC）0.83，95%CI 0.78至0.94）和测试数据集（AUC 0.82，95%CI 0.77至0.92）中对ER均表现出较强的区分能力。与MM-SES-CD评分模型相比，原始SES-CD评分在预测ER实现方面缺乏准确性（AUC 0.60，95%CI 0.55至0.65）。
我们开发并内部验证了MM-SES-CD作为一种内镜严重程度评估工具，用于预测接受积极治疗的克罗恩病患者的1年ER。
