■抗肿瘤坏死因子(TNF)单克隆抗体,尤其是英夫利昔单抗(IFX)和阿达木单抗(ADA),被认为是活动性克罗恩病(CD)的一线治疗方法。然而,血清抗TNF治疗药物监测(TDM)对炎症性肠病(IBD)治疗的预测作用仍存在争议.
■使用基于TDM的列线图探讨活动性CD中血清抗TNF水平与早期内窥镜反应之间的相关性。
■横断面研究。
■CD的简化内窥镜活动评分(SES-CD),克罗恩病活动指数(CDAI),实验室参数,评估IFX和ADA的血清谷水平。
■在发展队列中,有内窥镜反应的患者的IFX或ADA的谷水平明显高于无反应者(p<0.001)。IFX和ADA水平与SES-CD呈微弱但显著负相关(p<0.001),CDAI(p<0.001),发展队列中IFX治疗后第14周的C反应蛋白(CRP)(p<0.001)。此外,受试者工作特征曲线显示,IFX(4.80μg/mL)和ADA(8.80μg/mL)的最佳水平在预测内镜反应方面表现出最佳性能.同时,我们基于多变量逻辑回归分析的结果开发了一种新的列线图预测模型,由CRP组成,白蛋白(Alb),和第14周抗TNF谷水平。列线图显示开发队列中IFX和ADA两者的显著区分和校准,并且在外部验证队列中表现良好。
■这项研究证明了IFX的血清浓度之间的强关联,ADA,Alb,活动性CD患者的CRP和原发性内镜反应。重要的是,基于TDM和实验室标记的列线图可用于评估抗TNF治疗的主要内镜反应,特别是在CD患者中优化治疗策略和转换治疗。
基于治疗药物监测的列线图预测克罗恩病的原发性内镜反应本研究建立了基于治疗药物监测的列线图,表现出非凡的预测价值,非凡的准确性,和歧视。该算法列线图具有增强临床医生对导致个体患者未能实现预期疗效的潜在机制的理解的潜力。这种方法对于优化治疗选择和促进难治性克罗恩病的生物学转换至关重要。
UNASSIGNED: Anti-tumor necrosis factor (TNF) monoclonal antibodies, especially infliximab (IFX) and adalimumab (ADA), are considered the first-line treatment for active Crohn\'s disease (CD). However, the predictive role of therapeutic drug monitoring (
TDM) of serum anti-TNF in monitoring the treatment of inflammatory bowel disease (IBD) remains controversial.
UNASSIGNED: To explore the correlation between serum anti-TNF levels and early endoscopic response in active CD using a
TDM-based nomogram.
UNASSIGNED: Cross-sectional study.
UNASSIGNED: The simplified endoscopic activity score for CD (SES-CD), Crohn\'s disease activity index (CDAI), laboratory parameters, and the serum trough levels of IFX and ADA were assessed.
UNASSIGNED: The trough levels of IFX or ADA were significantly higher in patients with endoscopic response compared to non-responders in the development cohort (p < 0.001). The IFX and ADA levels showed a weak but significantly negative correlation with SES-CD (p < 0.001), CDAI (p < 0.001), and C-reactive protein (CRP) (p < 0.001) at week 14 post-IFX therapy in the development cohort. Furthermore, the receiver operating characteristic curve revealed that an optimal level of IFX (4.80 μg/mL) and ADA (8.80 μg/mL) exhibited the best performance in predicting endoscopic response. Concomitantly, we developed a novel nomogram prediction model based on the results of multivariate logistic regression analysis, which consisted of CRP, albumin (Alb), and anti-TNF trough levels at week 14. The nomogram showed significant discrimination and calibration for both IFX and ADA in the development cohort and performed well in the external validation cohort.
UNASSIGNED: This study demonstrates a robust association between serum concentrations of IFX, ADA, Alb, and CRP and primary endoscopic response in active CD patients. Importantly, the
TDM- and laboratory marker-based nomogram may be used to evaluate the primary endoscopic response to anti-TNF therapy, especially for optimizing treatment strategies and switching therapy in CD patients.
Therapeutic drug monitoring-based nomogram predicts primary endoscopic response in Crohn’s disease The present study established a therapeutic drug monitoring-based nomogram, which exhibits an exceptional predictive value, remarkable accuracy, and discrimination. This algorithmic nomogram holds the potential to enhance clinicians’ comprehension of the underlying mechanisms contributing to individual patients’ failure in achieving expected efficacy. Such approach is crucial for optimizing therapy options and facilitating biologic switching in refractory Crohn’s disease.