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炎症性肠病患者坚持一线晚期治疗的驱动因素:来自三级转诊中心的真实世界研究

Factors driving persistence to first-line advanced therapies in inflammatory bowel disease: a real-world study from a tertiary referral centre.

作者信息

Lenti Marco Vincenzo, Santacroce Giovanni, Lepore Federica, Mordà Francesco, Lo Bello Antonio, Aronico Nicola, Mengoli Caterina, Delliponti Mariangela, Frondana Raphael, Frondana Iara Moreira, Di Sabatino Antonio

机构信息

Department of Internal Medicine and Medical Therapeutics, University of Pavia, Pavia, Italy.

First Department of Internal Medicine, Clinica Medica I, Fondazione IRCCS Policlinico San Matteo, Università Di Pavia, Piazzale Golgi 19, 27100, Pavia, Italy.

出版信息

Intern Emerg Med. 2025 Apr 25. doi: 10.1007/s11739-025-03943-1.

DOI:10.1007/s11739-025-03943-1
PMID:40281202
Abstract

Factors driving the persistence of advanced therapies-defined as the duration from therapy initiation to discontinuation-in inflammatory bowel disease (IBD) remain unclear. This study aimed to evaluate the persistence of biologics and oral small molecules in a real-word IBD cohort and to identify influencing factors. Data from IBD patients starting advanced therapy at a tertiary referral centre after 2010 were retrospectively collected, including persistence and discontinuation reasons. Differences in persistence probability among therapies were analysed, and factors influencing persistence versus discontinuation due to failure were assessed by univariate and multivariate analyses. Among 274 included patients [median age 42.5 years; F/M 119/155; 146 with Crohn's disease (CD) and 128 with ulcerative colitis; median follow-up 38 months (IQR 14-75)], 141 (51.5%) remained persistent with first-line therapy, while 70 (26%) discontinued due to failure. No significant difference in persistence was observed among drugs (p = 0.11). Univariate analysis identified CD phenotype (p < 0.01), disease duration prior to therapy (p = 0.01), concomitant mesalamine or steroids (p < 0.01), and therapy optimisation (p < 0.01) as factors influencing persistence. Multivariate analysis confirmed CD phenotype as associated with higher persistence, while therapy optimisation was linked to increased discontinuation risk. CD was associated with better drug persistence, while therapy optimisation correlated with a higher discontinuation rate. Targeting deep healing and enhancing timely, precise optimisation strategies is essential for improving treatment outcomes.

摘要

在炎症性肠病(IBD)中,推动先进疗法持续使用的因素(定义为从开始治疗到停药的持续时间)仍不明确。本研究旨在评估真实世界IBD队列中生物制剂和口服小分子药物的持续使用情况,并确定影响因素。回顾性收集了2010年后在三级转诊中心开始接受先进疗法的IBD患者的数据,包括持续使用情况和停药原因。分析了不同疗法之间持续使用概率的差异,并通过单因素和多因素分析评估了影响因治疗失败而持续使用或停药的因素。在纳入的274例患者中[中位年龄42.5岁;女性/男性119/155;146例克罗恩病(CD)患者和128例溃疡性结肠炎患者;中位随访38个月(四分位间距14 - 75)],141例(51.5%)一线治疗持续有效,而70例(26%)因治疗失败而停药。各药物之间的持续使用情况无显著差异(p = 0.11)。单因素分析确定CD表型(p < 0.01)、治疗前疾病持续时间(p = 0.01)、同时使用美沙拉嗪或类固醇(p < 0.01)以及治疗优化(p < 0.01)为影响持续使用的因素。多因素分析证实CD表型与更高的持续使用率相关,而治疗优化与停药风险增加有关。CD与更好的药物持续使用相关,而治疗优化与更高的停药率相关。针对深度愈合并加强及时、精确的优化策略对于改善治疗结果至关重要。

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本文引用的文献

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Multi-OMICs orchestration enabled by artificial intelligence in inflammatory bowel disease: An exciting future.人工智能助力炎症性肠病中的多组学协调:激动人心的未来。
United European Gastroenterol J. 2024 Dec;12(10):1350-1351. doi: 10.1002/ueg2.12663. Epub 2024 Nov 7.
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Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.溃疡性结肠炎连续治疗152周后mirikizumab的三年疗效和安全性:LUCENT-3开放标签扩展研究结果
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A longitudinal single-cell atlas of anti-tumour necrosis factor treatment in inflammatory bowel disease.
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Corticosteroid Use in Randomized Clinical Trials of Biologics and Small Molecules in Inflammatory Bowel Disease: A Systematic Review.生物制剂和小分子药物用于炎症性肠病的随机临床试验中皮质类固醇的使用:一项系统评价
Inflamm Bowel Dis. 2025 May 12;31(5):1430-1440. doi: 10.1093/ibd/izae240.
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Proactive Therapeutic Drug Monitoring of Ustekinumab Is Associated With Increased Drug Persistence in Patients With Inflammatory Bowel Disease.乌司奴单抗的主动治疗药物监测与炎症性肠病患者药物持续使用时间增加相关。
Inflamm Bowel Dis. 2024 Sep 26. doi: 10.1093/ibd/izae231.
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Mucosal and Transmural Healing and Long-term Outcomes in Crohn's Disease.克罗恩病的黏膜及透壁愈合与长期预后
Inflamm Bowel Dis. 2025 Mar 3;31(3):857-877. doi: 10.1093/ibd/izae159.
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Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease.瑞莎珠单抗与乌司奴单抗治疗中重度克罗恩病的疗效比较。
N Engl J Med. 2024 Jul 18;391(3):213-223. doi: 10.1056/NEJMoa2314585.
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Inflamm Bowel Dis. 2025 Feb 6;31(2):485-491. doi: 10.1093/ibd/izae140.
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Navigating the complexities of drug development for inflammatory bowel disease.探讨炎症性肠病药物研发的复杂性。
Nat Rev Drug Discov. 2024 Jul;23(7):546-562. doi: 10.1038/s41573-024-00953-0. Epub 2024 May 22.
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Meta-analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease.荟萃分析:高级治疗在炎症性肠病治疗中的持续存在。
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