钙蛋白酶
医学
胃肠病学
内科学
安慰剂
粪钙保护素
曲线下面积
接收机工作特性
临床试验
粪便
C反应蛋白
溃疡性结肠炎
随机对照试验
析因分析
炎症性肠病
病理
炎症
疾病
生物
古生物学
替代医学
作者
Vipul Jairath,David T. Rubin,Bram Verstockt,Ayhan Hilmi Çekın,María T. Abreu,Charlie W. Lees,Marc Fellmann,John Woolcott,Catherine Crosby,Joseph Wu,Abhishek Bhattacharjee,David C. Herman,Guibao Gu,Britta Siegmund
出处
期刊:Inflammatory Bowel Diseases
[Oxford University Press]
日期:2024-06-20
摘要
Abstract Background Biomarkers offer potential alternatives to endoscopies in monitoring ulcerative colitis (UC) progression and therapeutic response. This post hoc analysis of the ELEVATE UC clinical program assessed potential predictive values of fecal calprotectin (fCAL) and high-sensitivity C-reactive protein (hsCRP) as biomarkers and associated responses to etrasimod, an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active UC, in 2 phase 3 clinical trials. Methods In ELEVATE UC 52 and ELEVATE UC 12, patients were randomized 2:1 to 2 mg of etrasimod once daily or placebo for 52 or 12 weeks, respectively. Fecal calprotectin/hsCRP differences between responders and nonresponders for efficacy end points (clinical remission, clinical response, endoscopic improvement-histologic remission [EIHR]) were assessed by Wilcoxon P-values. Sensitivity and specificity were presented as receiver operating characteristics (ROC) curves with area under the curve (AUC). Results In ELEVATE UC 52 and ELEVATE UC 12, 289 and 238 patients received etrasimod and 144 and 116 received placebo, respectively. Baseline fCAL/hsCRP concentrations were generally balanced. Both trials had lower week-12 median fCAL levels in week-12 responders vs nonresponders receiving etrasimod for clinical remission, clinical response, and EIHR (all P < .001), with similar trends for hsCRP levels (all P < .01). For etrasimod, AUCs for fCAL/hsCRP and EIHR were 0.85/0.74 (week 12; ELEVATE UC 52), 0.83/0.69 (week 52; ELEVATE UC 52), and 0.80/0.65 (week 12; ELEVATE UC 12). Conclusions Fecal calprotectin/hsCRP levels decreased with etrasimod treatment; ROC analyses indicated a prognostic correlation between fCAL changes during induction and short-/long-term treatment response.
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