Department of Medicine [Division of Gastroenterology] and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada.
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
J Crohns Colitis. 2022 May 10;16(4):616-624. doi: 10.1093/ecco-jcc/jjab183.
This study evaluated the minimal clinically important short-term improvement in the Modified Multiplier Simple Endoscopic Score for crohn's Disease [MM-SES-CD], a novel modified scoring system of the SES-CD, which reliably predicted 1-year endoscopic remission [ER].
This post-hoc analysis of two CD clinical trial programmes pooled data of 198 participants with baseline ulcers and SES-CD ≥3, who had baseline, post-induction [8-12 weeks], and 1-year endoscopic assessments. Different cut-off values for endoscopic response were evaluated using receiver operating characteristic [ROC] curves, positive likelihood ratios [PLR], and negative likelihood ratios [NLR]. ER [SES-CD <3] was the binary classifier in all cases. A distribution of cut-offs minimising NLR and maximising PLR was created with 10 000 bootstrapped resamples. An optimal cut-point for low and high probability of 1-year ER was determined based on the maximum Youden Index.
MM-SES-CD ≥40% reduction from baseline was selected as the cut-off maximising PLR and minimising NLR. Among 7.6% [15/198] participants achieving this cut-off post-induction, 1-year ER was 46.7%. One-year ER was 16.9% among those not achieving this cut-off. This threshold predicted 1-year ER with 95.0% (95% confidence interval [CI] 90.4%-97.8%) specificity and a PLR of 3.7 [95% CI 1.4-9.5], which was higher than traditional endoscopic response criteria of SES-CD ≥50% reduction [specificity 62.5%, 95% CI 54.5%-70.0%; PLR 1.9, 95% CI 1.4-2.5]. Lower thresholds of MM-SES-CD reduction also were highly specific for 1-year ER [e.g., MM-SES-CD ≥20% reduction was achieved in 19.7% of patients with 83.1% specificity].
In CD patients, post-induction endoscopic response defined by MM-SES-CD ≥40% reduction from baseline identified patients most likely to achieve 1-year ER.
本研究评估了改良乘数简化克罗恩病内镜评分（MM-SES-CD）的短期临床最小改善，这是 SES-CD 的一种新的改良评分系统，能够可靠地预测 1 年的内镜缓解（ER）。
本研究对两个 CD 临床试验项目进行了事后分析，共纳入了 198 名基线存在溃疡且 SES-CD≥3 的患者，这些患者进行了基线、诱导后（8-12 周）和 1 年的内镜评估。使用接收者操作特征（ROC）曲线、阳性似然比（PLR）和阴性似然比（NLR）评估不同的内镜反应截断值。在所有情况下，内镜缓解（SES-CD＜3）都是二分类分类器。通过 10000 次 bootstrap 重采样创建了一个最小化 NLR 并最大化 PLR 的截断值分布。根据最大 Youden 指数确定了 1 年 ER 低概率和高概率的最佳截断点。
从基线开始，MM-SES-CD 降低≥40%被选为最大化 PLR 和最小化 NLR 的截断值。在诱导后达到该截断值的 7.6%[15/198]患者中，1 年 ER 为 46.7%。而未达到该截断值的患者 1 年 ER 为 16.9%。该阈值预测 1 年 ER 的特异性为 95.0%（95%置信区间[CI] 90.4%-97.8%），PLR 为 3.7（95%CI 1.4-9.5），高于 SES-CD 降低≥50%的传统内镜反应标准[特异性 62.5%，95%CI 54.5%-70.0%；PLR 1.9，95%CI 1.4-2.5]。较低的 MM-SES-CD 降低阈值也对 1 年 ER 具有高度特异性[例如，在 19.7%的患者中，MM-SES-CD 降低≥20%，特异性为 83.1%]。
在 CD 患者中，诱导后 MM-SES-CD 降低≥40%从基线定义的内镜反应可确定最有可能在 1 年内达到 ER 的患者。
