Induction with upadacitinib in Crohn's disease: real-world experience from an early-access program in Greece.

IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY
Annals of Gastroenterology Pub Date : 2025-05-01 Epub Date: 2025-04-28 DOI:10.20524/aog.2025.0969
Evgenia Papathanasiou, Alexandros Ioannou, Pavlos Pardalis, Giorgos Leonidakis, George Michalopoulos, Spilios Manolakopoulos, Spyridon Siakavellas, Angeliki Theodoropoulou, Athanasia Tasovasili, Olga Giouleme, Maria Tzouvala, Eftychia Tsironi, Nikos Viazis, Spyridon Michopoulos, Evanthia Zampeli
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引用次数: 0

Abstract

Background: Upadacitinib is a selective Janus kinase-1 inhibitor, approved for the management of Crohn's disease (CD) by the United States Food & Drug Administration. In Greece, upadacitinib was initially available through an early-access program. Our goal was to describe the real practice experience.

Methods: This was a multicenter retrospective cohort study of patients with moderate-to-severe CD. The primary endpoint was clinical response, defined as a reduction ≥3 in the Harvey-Bradshaw index. Secondary endpoints included biochemical improvement. Outcomes were assessed at 4, 8 and 12 weeks.

Results: A total of 24 CD patients received upadacitinib and were included in the analysis. Their mean age was 42.2 years (range 24-63). Eleven patients (45.8%) had ileocolonic CD and 5 (20.8%) CD colitis. Fourteen patients had active extraintestinal manifestations. The majority of patients (19/24) had ≥3 failed biologics. All of them had failed treatment with anti-tumor necrosis factor and 19 (79%) with ustekinumab. At 12 weeks, nearly all patients achieved a clinical response (85%). Of 13 patients with C-reactive protein >5 mg/L at baseline, 11 (84.6%) achieved normalization by week 8. Adverse events occurred in 3 patients (14.2%).

Conclusion: In a small cohort of resistant CD patients, the short-term clinical efficacy of upadacitinib was high.

Abstract Image

Abstract Image

upadacitinib诱导治疗克罗恩病:来自希腊早期准入项目的真实世界经验
背景:Upadacitinib是一种选择性Janus激酶-1抑制剂,已被美国食品和药物管理局批准用于克罗恩病(CD)的治疗。在希腊,upadacitinib最初是通过早期获取计划获得的。我们的目标是描述真实的实践经验。方法:这是一项针对中重度CD患者的多中心回顾性队列研究。主要终点是临床反应,定义为Harvey-Bradshaw指数降低≥3。次要终点包括生化改善。在4周、8周和12周时评估结果。结果:共有24例CD患者接受了upadacitinib治疗,并被纳入分析。平均年龄42.2岁(24-63岁)。11例(45.8%)有回结肠CD, 5例(20.8%)有CD结肠炎。14例患者有活跃的肠外表现。大多数患者(19/24)有≥3种失败的生物制剂。抗肿瘤坏死因子治疗全部失败,ustekinumab治疗19例(79%)。在12周时,几乎所有患者(85%)都获得了临床缓解。在13例基线时c -反应蛋白bbb5 mg/L的患者中,11例(84.6%)在第8周达到正常化。不良事件3例(14.2%)。结论:在一小部分耐药乳糜泻患者中,upadacitinib的短期临床疗效较高。
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来源期刊
Annals of Gastroenterology
Annals of Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
4.30
自引率
0.00%
发文量
58
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