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一线生物制剂治疗克罗恩病患者达到生化缓解的最佳时间框架:一项回顾性多中心研究。

Optimal timeframe for achieving biochemical remission in Crohn's disease patients treated with first-line biologics: A retrospective multicenter study.

机构信息

Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, South Korea.

Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.

出版信息

Medicine (Baltimore). 2024 Oct 11;103(41):e40074. doi: 10.1097/MD.0000000000040074.

DOI:10.1097/MD.0000000000040074
PMID:39465809
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11479425/
Abstract

Predicting treatment response in Crohn's disease (CD) patients initiating biological therapy is crucial. The first step involves considering symptom control and normalization of C-reactive protein (CRP). However, data on the actual rates of achieving CRP normalization and the appropriate timeframe are lacking. Therefore, we aim to investigate the rate of attaining CRP normalization and identify its optimal timeframe in CD patients initiating biological therapy. In this retrospective multi-center study, we analyzed moderate to severe CD patients initiating biological therapy from January 2012 to July 2023. The primary outcome was the rate and timeframe for achieving CRP normalization. Secondary outcomes included clinical outcomes in patients who achieved CRP normalization and factors associated with early CRP normalization. Of 183 patients, 123 (67.2%) achieved CRP normalization, with a median duration of 3.8 months (interquartile range 1.4 to 7.4 months). The duration and value difference for CRP normalization between anti-tumor necrosis factor agents, ustekinumab, and vedolizumab were statistically insignificant. Cumulative rates of CD-related hospitalization, intestinal resection, and drug discontinuation over 8 years were 11.4%, 2.4%, and 12.2%, respectively. The duration of CRP normalization correlates with drug discontinuation (area under the curve: 0.64). Treatment with 5-aminosalicylic acid (HR 2.77; 95% confidence interval [CI] 1.26-6.11) and high albumin level (HR 1.64, 95% CI 1.04-2.61) favored early CRP normalization, whereas structuring behavior less likely than inflammatory behavior (HR 0.43, 95% CI 0.19-0.96). We have provided the actual rate of achieving CRP normalization and its appropriate timeframe as an initial target in CD treatment.

摘要

预测接受生物治疗的克罗恩病(CD)患者的治疗反应至关重要。第一步涉及考虑症状控制和 C 反应蛋白(CRP)的正常化。然而,缺乏关于实现 CRP 正常化的实际比率和适当时间框架的数据。因此,我们旨在研究 CD 患者接受生物治疗后实现 CRP 正常化的比率,并确定其最佳时间框架。在这项回顾性多中心研究中,我们分析了 2012 年 1 月至 2023 年 7 月期间接受生物治疗的中重度 CD 患者。主要结局是 CRP 正常化的比率和时间框架。次要结局包括 CRP 正常化患者的临床结局和与 CRP 早期正常化相关的因素。在 183 名患者中,123 名(67.2%)实现了 CRP 正常化,中位时间为 3.8 个月(四分位距 1.4 至 7.4 个月)。抗 TNF 药物、乌司奴单抗和维得利珠单抗的 CRP 正常化时间和数值差异无统计学意义。8 年内 CD 相关住院、肠切除术和药物停药的累积发生率分别为 11.4%、2.4%和 12.2%。CRP 正常化的持续时间与药物停药相关(曲线下面积:0.64)。5-氨基水杨酸(HR 2.77;95%置信区间 [CI] 1.26-6.11)和高白蛋白水平(HR 1.64,95% CI 1.04-2.61)的治疗有利于 CRP 的早期正常化,而结构行为比炎症行为更不可能(HR 0.43,95% CI 0.19-0.96)。我们已经提供了实现 CRP 正常化的实际比率及其作为 CD 治疗初始目标的适当时间框架。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/d44177b58a0b/medi-103-e40074-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/762dc6bbf45d/medi-103-e40074-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/9d42a54b3e45/medi-103-e40074-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/d44177b58a0b/medi-103-e40074-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/762dc6bbf45d/medi-103-e40074-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/9d42a54b3e45/medi-103-e40074-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11479425/d44177b58a0b/medi-103-e40074-g003.jpg

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本文引用的文献

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J Clin Med. 2023 Mar 20;12(6):2397. doi: 10.3390/jcm12062397.
2
Interpreting area under the receiver operating characteristic curve.解读受试者工作特征曲线下的面积
Lancet Digit Health. 2022 Dec;4(12):e853-e855. doi: 10.1016/S2589-7500(22)00188-1. Epub 2022 Oct 18.
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Comparative Effectiveness of Ustekinumab and Anti-TNF Agent as First-Line Biological Therapy in Luminal Crohn's Disease: A Retrospective Study From 2 Referral Centers.
乌司奴单抗与抗 TNF 制剂作为肠病性克罗恩病一线生物治疗药物的疗效比较:来自 2 家转诊中心的回顾性研究。
Inflamm Bowel Dis. 2023 Jun 1;29(6):923-931. doi: 10.1093/ibd/izac167.
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Exploring the concept of deep remission in Crohn's disease: correlation between transmural healing and biomarkers.探索克罗恩病深度缓解的概念:透壁愈合与生物标志物之间的相关性。
Therap Adv Gastroenterol. 2022 Jul 22;15:17562848221110643. doi: 10.1177/17562848221110643. eCollection 2022.
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