Background Upadacitinib is a Janus kinase inhibitor, which has recently been approved for treating Crohn’s disease. There are limited real-world studies on the outcomes of upadacitinib in Crohn’s disease. Objective Our aim was to evaluate the outcomes of upadacitinib in a real-world Crohn’s disease cohort. Methods We conducted a retrospective, multicentre, cohort study over a 2-year period across National Health Service (NHS) Lothian and Royal Devon University Healthcare NHS Foundation Trust. The primary outcome was treatment persistence at week 24. Secondary endpoints were corticosteroid-free clinical remission (Harvey-Bradshaw Index (HBI)<5) and biomarker remission (C-reactive protein (CRP)≤5 mg/L and faecal calprotectin (FCAL)<250 µg/g) at 12, 24 and 52 weeks. We recorded adverse events. Results 135 patients commenced upadacitinib as of the 1 January 2024, of which 93 patients with active Crohn’s disease were included with a minimum of 12 weeks follow-up. The median follow-up time was 25 weeks (IQR 15–42 weeks). 82% of the cohort had exposure to at least two classes of advanced therapies, and 52% had exposure to at least three classes of advanced therapies. Treatment persistence was 87.1% at week 12, 81.7% at week 24 and 62.8% at week 52. Rates of clinical remission were 64% (42/66), 48% (22/46) and 38% (8/21) at weeks 12, 24 and 52, respectively. Significant reductions in HBI, CRP and FCAL were observed during follow-up. 14% (13/91) had a hospitalisation due to Crohn’s disease. Adverse events occurred in 40% (37/93) of the cohort, of which 12% (11/93) were serious. Conclusion Upadacitinib was effective in a real-world, highly refractory, Crohn’s disease cohort with good persistence. Data are available on reasonable request.

中文翻译：

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乌帕替尼治疗克罗恩病的真实疗效：英国多中心回顾性队列研究


背景 Upadacitinib 是一种 Janus 激酶抑制剂，最近被批准用于治疗克罗恩病。关于 upadacitinib 治疗克罗恩病的效果的现实世界研究有限。目的 我们的目的是评估 upadacitinib 在现实世界克罗恩病队列中的结果。方法 我们在国家医疗服务体系 (NHS) 洛锡安和皇家德文大学医疗保健 NHS 基金会信托基金中进行了一项为期 2 年的回顾性、多中心、队列研究。主要结局是第 24 周时的治疗持续性。次要终点是无皮质类固醇临床缓解（Harvey-Bradshaw 指数 (HBI)<5）和生物标志物缓解（C 反应蛋白 (CRP)≤5 mg/L 和粪便钙卫蛋白 (FCAL) )<250 µg/g) 在第 12、24 和 52 周时。我们记录了不良事件。结果 截至 2024 年 1 月 1 日，共有 135 名患者开始接受 upadacitinib 治疗，其中 93 名患有活动性克罗恩病的患者接受了至少 12 周的随访。中位随访时间为 25 周（IQR 15-42 周）。该队列中 82% 的人接受过至少两类先进疗法，52% 的人接受过至少三类先进疗法。第 12 周、第 24 周和第 52 周的治疗持续率分别为 87.1%、81.7% 和 62.8%。临床缓解率分别为 64% (42/66)、48% (22/46) 和 38% (8/21)。分别为第 12、24 和 52 周。随访期间观察到 HBI、CRP 和 FCAL 显着降低。 14% (13/91) 因克罗恩病住院。该队列中有 40% (37/93) 发生不良事件，其中 12% (11/93) 为严重不良事件。结论 乌帕替尼在现实世界的高度难治性克罗恩病队列中有效，且具有良好的持久性。可根据合理要求提供数据。