英国东米德兰地区乌司替尼治疗克罗恩病的实际临床效果

IF 2.4 Q3 GASTROENTEROLOGY & HEPATOLOGY Frontline Gastroenterology Pub Date : 2024-06-14 DOI:10.1136/flgastro-2024-102718
Jonathan Richard White, Saqib Ahmad, Fahad Ashraf, Stephen Foley, Said Din, R. Das, Nina Mary Charles, João Pinheiro, Altaf Palejwala, Pamela Wright, Manoharan Andiappan, Myriam Alexander, Burhan Uddin, D. Hoshen, David A Elphick, Tufail Qamar, Nivin Rezwan, Mohammad Viquaruddin Hamza, John Glover, R. Robinson, Veena Gopakumar, A. Sajjad, Muhammad Shahzad, Gordon Moran
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引用次数: 0

摘要

这是一项多中心、回顾性观察研究,研究对象是2016年11月11日至2020年8月1日期间在英国8家医院开始使用乌司替尼的CD或未分类型炎症性肠病(IBDU)患者(年龄≥18岁)。主要目的是确定CD/IBDU患者开始使用乌司替库单抗后,在第52周达到无皮质类固醇缓解的患者比例。无皮质类固醇缓解的定义是临床哈维-布拉德肖指数(HBI)评分≤4分且无皮质类固醇状态。第16周无皮质类固醇缓解率为41%(68/166),第30周为41%(47/115),第52周为48%(38/80)。临床缓解率在第 16 周为 51%(85/166),在第 52 周为 50%(40/80)。第16周时,临床应答率为34%(43/125),第52周时为32%(17/53)。客观缓解率在第16周为40%(4/10),在第52周为70%(7/10)。在第52周达到无皮质类固醇缓解的患者中,既往使用过1-2种生物制剂和/或口服小分子药物的患者占56%(35/63),无手术史的患者占64%(16/25),无穿透性疾病的患者占54%(29/54)。在第16周达到临床缓解的患者与未达到临床缓解的患者(20%;4/20)相比,在第52周达到无皮质类固醇缓解的可能性更大(70%;14/20)。这项多中心研究提供了英国CD/IBDU患者使用乌司替尼的实际经验。
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Real-world clinical effectiveness of ustekinumab in the treatment of Crohn’s disease in the East Midlands UK
To evaluate the effectiveness of ustekinumab in treating Crohn’s disease (CD) in a UK real-world setting.This was a multicentre, retrospective observational study of patients (aged ≥18 years) with CD or inflammatory bowel disease of unclassified type (IBDU) starting ustekinumab between 11 November 2016 and 1 August 2020 across eight English hospitals. The primary objective was to determine the proportion of patients achieving corticosteroid-free remission at week 52 for patients with CD/IBDU following initiation with ustekinumab. Corticosteroid-free remission was defined as achieving a clinical Harvey-Bradshaw Index (HBI) score of ≤4 and corticosteroid-free status.The analysis included 422 patients with CD/IBDU. Corticosteroid-free remission was 41% (68/166) at week 16, 41% (47/115) at week 30 and 48% (38/80) at week 52. Clinical remission was 51% (85/166) at week 16 and 50% (40/80) at week 52. Clinical response was 34% (43/125) at week 16 and 32% (17/53) at week 52. Objective remission was 40% (4/10) at week 16 and 70% (7/10) at week 52. Corticosteroid-free remission at week 52 was achieved in patients with previous exposure to 1–2 biologics and/or small oral molecules (56%; 35/63), those without surgical history (64%; 16/25), and those without penetrating disease (54%; 29/54). Patients who achieved clinical remission at week 16 were more likely to achieve corticosteroid-free remission at week 52 (70%; 14/20) versus those who did not (20%; 4/20). In total, 37 adverse events occurred in 21 patients.This multicentre study provides real-world experience of ustekinumab in patients with CD/IBDU in England.
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来源期刊
Frontline Gastroenterology
Frontline Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
4.70
自引率
11.50%
发文量
93
期刊介绍: Frontline Gastroenterology publishes articles that accelerate adoption of innovative and best practice in the fields of gastroenterology and hepatology. Frontline Gastroenterology is especially interested in articles on multidisciplinary research and care, focusing on both retrospective assessments of novel models of care as well as putative future directions of best practice. Specifically Frontline Gastroenterology publishes articles in the domains of clinical quality, patient experience, service provision and medical education.
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