Pauwels Renske W M, Ten Bokkel Huinink Sebastiaan, van der Woude Christien J, Doukas M, Oudijk L, de Vries Annemarie C
Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands.
Department of Pathology, Erasmus MC, Rotterdam, The Netherlands.
Scand J Gastroenterol. 2023 Jul-Dec;58(9):980-987. doi: 10.1080/00365521.2023.2194009. Epub 2023 Mar 27.
Response evaluation after induction therapy with ustekinumab (UST) in Crohn's disease (CD) is important for decisions on maintenance therapy. We aimed to assess the potential of fecal calprotectin (FC) levels to predict endoscopic response at week 16.
CD patients with FC >100 µg/g and endoscopic active disease (SES-CD> 2, Rutgeerts' score ≥ i2) at initiation of UST therapy were enrolled. FC was determined at weeks 0, 2, 4, 8 and 16 and patients underwent a colonoscopy at week 16. The primary outcome was an endoscopic response at week 16 (SES-CD score ≥50% decrease or a decrease of ≥1 points in Rutgeerts' score). The optimal cut-off levels of FC and change in FC to predict endoscopic response were determined using ROC statistics.
59 CD patients were included. Endoscopic response was observed in 21/59 (36%) patients. The diagnostic accuracy for FC levels at week 8 to predict endoscopic response at week 16 showed a predictive value of 0.71. A decrease in FC levels ≥500 µg/g between baseline at week 8 indicates endoscopic response (PPV = 89%), whereas absence of any decrease indicates endoscopic non-response after induction (NPV = 81%).
Continuation of UST therapy without endoscopic response evaluation may be considered in patients with a decrease in FC levels of ≥500 µg/g at week 8. The decision on continuation of UST therapy or therapy optimization needs reconsideration in patients without a decrease of FC level. In all other patients, endoscopic response evaluation of induction therapy remains essential for therapeutic decisions.
在克罗恩病（CD）中，使用优特克单抗（UST）进行诱导治疗后的反应评估对于维持治疗的决策很重要。我们旨在评估粪便钙卫蛋白（FC）水平预测第16周内镜反应的潜力。
纳入在UST治疗开始时FC>100µg/g且内镜下有活动性疾病（SES-CD>2，鲁杰尔斯评分≥i2）的CD患者。在第0、2、4、8和16周测定FC，患者在第16周接受结肠镜检查。主要结局是第16周的内镜反应（SES-CD评分降低≥50%或鲁杰尔斯评分降低≥1分）。使用ROC统计确定预测内镜反应的FC最佳截断水平和FC变化。
纳入59例CD患者。21/59（36%）例患者观察到内镜反应。第8周时FC水平预测第16周内镜反应的诊断准确性显示预测值为0.71。第8周时FC水平较基线降低≥500µg/g表明内镜反应（阳性预测值=89%），而未出现任何降低表明诱导后内镜无反应（阴性预测值=81%）。
对于第8周时FC水平降低≥500µg/g的患者，可考虑在不进行内镜反应评估的情况下继续UST治疗。对于FC水平未降低的患者，继续UST治疗或优化治疗的决策需要重新考虑。在所有其他患者中，诱导治疗的内镜反应评估对于治疗决策仍然至关重要。
