D'Arcangelo Giulia, Oliva Salvatore, Dilillo Anna, Viola Franca, Civitelli Fortunata, Isoldi Sara, Cucchiara Salvatore, Aloi Marina
Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy.
J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):841-846. doi: 10.1097/MPG.0000000000002262.
We aimed to identify early noninvasive predictors of clinical and endoscopic remission in children with Crohn disease (CD) under infliximab (IFX).
Prospective observational study conducted in children with moderate-to-severe CD starting IFX. All patients underwent weighted pediatric CD activity index (wPCDAI) assessment, C-reactive protein and fecal calprotectin (FC) at week 0, 14, and 48. Endoscopy was performed at 0 and 48 weeks. The primary outcome was to determine the ability of 14-week wPCDAI, C-reactive protein, and FC to predict 1-year steroid-free clinical remission and mucosal healing. As a secondary outcome we evaluated their concordance with Simple Endoscopic Score for CD (SES-CD) at week 48.
Forty-one children were enrolled. At 1 year, 21 (51%) and 16 (39%) were in clinical and endoscopic remission. Only combined postinduction FC and wPCDAI were able to predict 1-year clinical and endoscopic remission (hazard ratio 4.81 [95% confidence interval 1.76-20.45], P = 0.05 and hazard ratio 5.51 [95% confidence interval 1.83-26.9], P = 0.03). One-year SES-CD moderately correlated with FC (r = 0.52; P = 0.001). The FC cut-off value for mucosal healing was 120.5 μg/g (area under the curve 0.863, 83% sensitivity, 75.5% specificity; P = 0.005). The concordance between wPCDAI and SES-CD was excellent and good for severe disease and remission (k 0.87 and 0.76).
Post induction FC combined with wPCDAI can predict 1-year clinical and endoscopic response to IFX in pediatric CD. FC shows a moderate correlation with SES-CD, whereas wPCDAI has a good concordance with endoscopic remission or severe disease, but not with mild and moderate disease.
我们旨在确定接受英夫利昔单抗（IFX）治疗的克罗恩病（CD）患儿临床和内镜缓解的早期非侵入性预测指标。
对开始使用IFX治疗的中重度CD患儿进行前瞻性观察研究。所有患者在第0、14和48周接受加权儿童CD活动指数（wPCDAI）评估、C反应蛋白和粪便钙卫蛋白（FC）检测。在第0周和第48周进行内镜检查。主要结局是确定第14周的wPCDAI、C反应蛋白和FC预测1年无类固醇临床缓解和黏膜愈合的能力。作为次要结局，我们评估了它们在第48周时与CD简单内镜评分（SES-CD）的一致性。
纳入41名儿童。1年后，21名（51%）和16名（39%）分别达到临床缓解和内镜缓解。仅诱导后FC与wPCDAI联合能够预测1年临床和内镜缓解（风险比4 .81[95%置信区间1.76 - 20.45]，P = 0.05；风险比为5.51[95%置信区间1.83 - 26.9]，P = 0.03）。1年SES-CD与FC中度相关（r = 0.52；P = 0.001）。黏膜愈合的FC临界值为120.5μg/g（曲线下面积0.863，灵敏度83%，特异性75.5%；P = 0.005）。wPCDAI与SES-CD之间对于严重疾病和缓解的一致性良好（κ值分别为0.87和0.76）。
诱导后FC联合wPCDAI可预测儿童CD患者对IFX治疗1年的临床和内镜反应。FC与SES-CD中度相关，而wPCDAI与内镜缓解或严重疾病一致性良好，但与轻中度疾病不一致。
