Castiglione Fabiana, Imperatore Nicola, Testa Anna, de Sire Roberto, Nardone Olga Maria, Ricciolino Simona, Di Luna Imma, Patturelli Marta, Villani Guido Daniele, Olmo Oriana, Rispo Antonio
Gastroenterology Unit, Department of Clinical Medicine and Surgery, 'Federico II' School of Medicine, Naples, Italy, Via S. Pansini 5, Naples 80131, Italy.
Gastroenterology and Endoscopy Unit, AORN Antonio Cardarelli, Naples, Italy.
Therap Adv Gastroenterol. 2022 Jul 22;15:17562848221110643. doi: 10.1177/17562848221110643. eCollection 2022.
While mucosal healing (MH) and transmural healing (TH) predict relevant clinical outcomes in Crohn's disease (CD), little is known about the real significance and clinical impact of deep remission (DR).
To better explore the concept of DR, toward a direct correlation between MH, TH, and biomarkers.
Real-world observational longitudinal study to evaluate the rate of clinical remission (CR), MH and TH, and the fecal calprotectin (FC)/C-reactive protein (CRP) levels in all consecutive CD patients on biologics.
A receiver operating characteristic (ROC) curve was constructed to define the best FC and CRP cut-offs associated with MH and TH. Finally, patients achieving CR, MH, and TH, in association with the target FC/CRP values, were considered in DR.
Among 118 CD patients, CR, MH, and TH were achieved in 62.7, 44.1, and 32.2%, respectively. After 2 years, the mean FC levels decreased from 494 ± 15.4 μg/g to 260 ± 354.9 μg/g ( < 0.01). Using the ROC curve analysis, an FC cut-off value of 94 μg/g was associated with both MH [sensitivity: 94.2%, specificity: 84.8%, positive predictive value (PPV): 83.05%, negative predictive value (NPV): 94.92%, area under the curve (AUC): 0.95] and TH (sensitivity: 92.1%, specificity: 70%, PPV: 64.4%, NPV: 94.9%, AUC: 0.88). CRP < 5 mg/L was associated with both MH (sensitivity: 96.1%, specificity: 62.1%, PPV: 66.7%, NPV: 95.35%, AUC: 0.85) and TH (sensitivity: 97.4%, specificity: 52.5%, PPV: 52%, NPV: 95.35%, AUC: 0.78). When considering CD patients with concomitant CR, MH, and TH associated with an FC < 94 μg/g and CRP < 5 mg/L, this association was found identified in 33 patients (27.9%).
An FC < 94 μg/g and a normal CRP are associated with CR, MH, and TH and could be included in the definition of DR in association. So by definition, DR could be achieved in approximately 30% of CD patients during maintenance treatment with biologics.
虽然黏膜愈合（MH）和透壁愈合（TH）可预测克罗恩病（CD）的相关临床结局，但对于深度缓解（DR）的实际意义和临床影响知之甚少。
为了更好地探究DR的概念，以实现MH、TH与生物标志物之间的直接关联。
一项真实世界的观察性纵向研究，旨在评估所有连续接受生物制剂治疗的CD患者的临床缓解（CR）率、MH和TH情况，以及粪便钙卫蛋白（FC）/C反应蛋白（CRP）水平。
构建受试者工作特征（ROC）曲线，以确定与MH和TH相关的最佳FC和CRP临界值。最后，将达到CR、MH和TH且FC/CRP值达标的患者视为处于DR状态。
在118例CD患者中，CR、MH和TH的实现率分别为62.7%、44.1%和32.2%。2年后，FC的平均水平从494±15.4μg/g降至260±354.9μg/g（P<0.01）。通过ROC曲线分析，FC临界值为94μg/g与MH相关（敏感性：94.2%，特异性：84.8%，阳性预测值[PPV]：83.05%，阴性预测值[NPV]：94.92%，曲线下面积[AUC]：0.95），也与TH相关（敏感性：92.1%，特异性：70%，PPV：64.4%，NPV：94.9%，AUC：0.88）。CRP<5mg/L与MH相关（敏感性：96.1%，特异性：62.1%，PPV：66.7%，NPV：95.35%，AUC：0.85），也与TH相关（敏感性：97.4%，特异性：52.5%，PPV：52%，NPV：95.35%，AUC：0.78）。当考虑同时达到CR、MH和TH且FC<94μg/g以及CRP<5mg/L的CD患者时，共有33例患者（27.9%）符合这一关联。
FC<94μg/g且CRP正常与CR、MH和TH相关，可纳入DR的联合定义中。因此，从定义上讲，在生物制剂维持治疗期间，约30%的CD患者可实现DR。
