炎症性肠病联合先进疗法的有效性、安全性和成本。

IF 4 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Digestive and Liver Disease Pub Date : 2024-09-21 DOI:10.1016/j.dld.2024.08.055
Cathy McShane, Rachel Varley, Anne Fennessy, Clodagh Byron, John Richard Campion, Karl Hazel, Conor Costigan, Eabha Ring, Alan Marrinan, Ciaran Judge, Kathleen Sugrue, Garret Cullen, Cara Dunne, Karen Hartery, Marietta Iacucci, Orlaith Kelly, Jan Leyden, Susan McKiernan, Aoibhlinn O'Toole, Juliette Sheridan, Eoin Slattery, Karen Boland, Deirdre McNamara, Laurence Egan, Subrata Ghosh, Glen Doherty, Jane McCarthy, David Kevans
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引用次数: 0

摘要

背景:相当一部分炎症性肠病(IBD)患者对先进疗法无效。联合使用先进疗法可改善治疗效果。本研究旨在评估IBD患者联合晚期疗法的疗效、不良反应和相关费用:联合晚期疗法的定义是同时使用两种生物制剂或一种生物制剂与一种小分子疗法。从电子病历中收集临床数据,包括疾病特征、治疗方案和不良事件。对临床反应率、生化指标和治疗费用进行了评估:研究纳入了来自爱尔兰 9 个学术中心的 109 名接受联合先进疗法的 IBD 患者。12周和52周的无皮质类固醇临床应答率分别为39%和38%。26%的治疗试验出现了不良事件,其中最常见的是疾病相关事件。值得注意的是,有 3 例非黑色素瘤皮肤癌和 10 例感染并发症。每名患者每年接受联合先进疗法的维持治疗费用从17,560欧元到30,724欧元不等:结论:联合先进疗法在一组难治性 IBD 患者中显示出有效性和可接受的安全性。要明确评估晚期联合疗法在 IBD 中的作用,还需要进一步开展大型前瞻性试验。
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Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease.

Background: A significant proportion of inflammatory bowel disease (IBD) patients fail to respond to advanced therapies. Combining advanced therapies may improve treatment outcome. This study aimed to assess the effectiveness, adverse events, and costs associated with combining advanced therapies in IBD patients.

Methods: Combination advanced therapy was defined as the concurrent use of two biological agents or one biological agent with a small molecule therapy. Clinical data, including disease characteristics, treatment regimens, and adverse events, were collected from electronic patient records. Clinical response rates, biochemical markers, and treatment costs were evaluated.

Results: The study included 109 IBD patients receiving combination advanced therapies from 9 academic centers in Ireland. Corticosteroid-free clinical response rates at 12 weeks and 52 weeks were 39 % and 38 %, respectively. Adverse events occurred in 26 % of therapeutic trials, with disease-related events being the most common. Notably, there were 3 cases of non-melanomatous skin cancer and 10 infectious complications. The annual cost of maintenance therapy for combination advanced therapies ranged from €17,560 to €30,724 per patient.

Conclusion: Combination advanced therapies demonstrated effectiveness and acceptable safety profiles in a cohort of treatment-refractory IBD patients. Further large, prospective trials are required to definitively evaluate the role of combination advanced therapies in IBD.

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来源期刊
Digestive and Liver Disease
Digestive and Liver Disease 医学-胃肠肝病学
CiteScore
6.10
自引率
2.20%
发文量
632
审稿时长
19 days
期刊介绍: Digestive and Liver Disease is an international journal of Gastroenterology and Hepatology. It is the official journal of Italian Association for the Study of the Liver (AISF); Italian Association for the Study of the Pancreas (AISP); Italian Association for Digestive Endoscopy (SIED); Italian Association for Hospital Gastroenterologists and Digestive Endoscopists (AIGO); Italian Society of Gastroenterology (SIGE); Italian Society of Pediatric Gastroenterology and Hepatology (SIGENP) and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Digestive and Liver Disease publishes papers on basic and clinical research in the field of gastroenterology and hepatology. Contributions consist of: Original Papers Correspondence to the Editor Editorials, Reviews and Special Articles Progress Reports Image of the Month Congress Proceedings Symposia and Mini-symposia.
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