Pauwels Renske W M, van der Woude Christien J, Erler Nicole S, de Vries Annemarie C
Erasmus MC, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands.
Erasmus MC, Department of Biostatistics, Rotterdam, The Netherlands.
Therap Adv Gastroenterol. 2020 Dec 24;13:1756284820979765. doi: 10.1177/1756284820979765. eCollection 2020.
Early prediction of the effect of vedolizumab (VDZ) in inflammatory bowel disease (IBD) is of paramount importance to guide clinical decisions. This study assessed whether early fecal calprotectin (FC) can predict endoscopic response and histologic remission after VDZ initiation.
This was a prospective study. Inclusion criteria were endoscopic inflammation and FC >100 µg/g. FC was determined at baseline and weeks 2, 4, 8 and 16. At week 16, endoscopies with ileal and colonic biopsies were performed. FC changes were assessed with Wilcoxon Rank Sum tests. ROC statistics were used to assess the diagnostic accuracy of FC.
In total, 45 patients [27 Crohn's disease (CD), 16/2 ulcerative colitis (UC)/IBD-unclassified] [40% males, median age 39 (28-51) years] were included. Week 16 endoscopic response and histologic remission rates were 58% and 33%. A median 37% decline in FC at week 2 was observed only in endoscopic responders, = 0.025. FC <250 µg/g at week 8 predicted endoscopic response in both UC and CD (positive predictive value 100%), whereas absence of FC decline at week 8 corresponded with absence of endoscopic response in CD [negative predictive value (NPV) 82%] and absence of histologic remission in both UC and CD (NPV 90%).
The onset of a decline in FC as early as week 2 is associated with endoscopic response to VDZ induction. FC <250 µg/g at week 8 is associated with endoscopic response, whereas absence of FC decline at week 8 is associated with absence of both endoscopic response and histologic remission. FC levels 8 weeks after the start of VDZ could be used to guide clinical decisions and might substitute for endoscopic response evaluation.
维多珠单抗（VDZ）治疗炎症性肠病（IBD）效果的早期预测对于指导临床决策至关重要。本研究评估了早期粪便钙卫蛋白（FC）是否能够预测VDZ开始治疗后的内镜反应和组织学缓解情况。
这是一项前瞻性研究。纳入标准为内镜下炎症且FC＞100µg/g。在基线以及第2、4、8和16周测定FC。在第16周，进行回肠和结肠活检的内镜检查。采用Wilcoxon秩和检验评估FC的变化。使用ROC统计量评估FC的诊断准确性。
总共纳入了45例患者[27例克罗恩病（CD），16/2例溃疡性结肠炎（UC）/未分类的IBD][40%为男性，中位年龄39（28 - 51）岁]。第16周的内镜反应率和组织学缓解率分别为58%和33%。仅在内镜反应者中观察到第2周时FC中位数下降了37%，P = 0.025。第8周时FC＜250µg/g可预测UC和CD的内镜反应（阳性预测值为100%），而第8周时FC未下降与CD的内镜无反应相关[阴性预测值（NPV）82%]以及UC和CD的组织学无缓解相关（NPV 90%）。
早在第2周FC下降的开始与VDZ诱导的内镜反应相关。第8周时FC＜250µg/g与内镜反应相关，而第8周时FC未下降与内镜无反应和组织学无缓解均相关。VDZ开始治疗8周后的FC水平可用于指导临床决策，并且可能替代内镜反应评估。
