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中国单中心研究:乌帕替尼治疗急性重度溃疡性结肠炎患者的疗效和安全性。

Effectiveness and safety of upadacitinib in acute severe ulcerative colitis patients from single Chinese IBD Center: a monocentric study.

机构信息

Xijing Hospital of Digestive Diseases, State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers and National Clinical Research Center for Digestive Diseases, Fourth Military Medical University, Xi'an, China.

Department of Pathology, The First Affiliated Hospital, Air Force Medical University, No.127 Chang Le West Road, Xi'an, 710032, China.

出版信息

Clin Exp Med. 2024 Sep 30;24(1):233. doi: 10.1007/s10238-024-01468-z.

DOI:10.1007/s10238-024-01468-z
PMID:39348049
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11442613/
Abstract

Upadacitinib is an oral new selective JAK1 inhibitor that has been approved for treating adult patients with moderately to severely active ulcerative colitis. However, a growing number of studies are needed on the effectiveness of upadacitinib in the treatment of acute severe ulcerative colitis. This study was mainly aimed to describe the clinical and endoscopic effectiveness of upadacitinib 45 mg in Chinese acute severe ulcerative colitis patients following eight weeks of treatment. In this study, we examined all patients with acute severe ulcerative colitis from Xijing IBD Center, Xi'an, China, with acute severe ulcerative colitis. All patients were initially given oral upadacitinib 45 mg. Clinical indicators, C-reactive protein, and erythrocyte sedimentation rates were collected. Clinical response and clinical remission were assessed using modified Mayo. Endoscopic evaluation was performed carried out using the Mayo Endoscopic Score and Ulcerative colitis endoscopic index of severity score. A total of 14 patients who received upadacitinib were included in the study period. All patients exhibited a clinical response to 45 mg upadacitinib initially. All patients completed the 8-week induction. The clinical remission rate was 28.6% after eight weeks. Two patients revealed endoscopic remission at 14.3%. The pathology improved in 50.0% of patients. The 8-week surgical resection rate was 7.1%, with the 16-week surgical resection rate being 14.3%. Adverse events included herpes simplex virus infection and increased thrombin time. The results of our study support the short-term effectiveness and safety of upadacitinib in acute severe ulcerative colitis, providing new choices for patients' treatment. However, more extended investigation needs to be performed on the long-term effectiveness and safety.

摘要

巴瑞替尼是一种新型选择性 JAK1 抑制剂,已被批准用于治疗中重度活动期溃疡性结肠炎的成年患者。然而,需要更多的研究来评估巴瑞替尼治疗急性重度溃疡性结肠炎的有效性。本研究主要旨在描述巴瑞替尼 45mg 在中国急性重度溃疡性结肠炎患者中的临床和内镜疗效,这些患者在经过 8 周的治疗后。在这项研究中,我们检查了来自中国西安西京 IBD 中心的所有急性重度溃疡性结肠炎患者。所有患者最初均给予口服巴瑞替尼 45mg。收集临床指标、C 反应蛋白和红细胞沉降率。采用改良 Mayo 评分评估临床缓解和临床缓解情况。在研究期间,共有 14 例接受巴瑞替尼治疗的患者纳入研究。所有患者最初对 45mg 巴瑞替尼均有临床反应。所有患者均完成了 8 周的诱导期。8 周后临床缓解率为 28.6%。2 例患者在 14 天时出现内镜缓解。50.0%的患者病理改善。8 周手术切除率为 7.1%,16 周手术切除率为 14.3%。不良事件包括单纯疱疹病毒感染和凝血酶时间延长。本研究结果支持巴瑞替尼治疗急性重度溃疡性结肠炎的短期有效性和安全性,为患者的治疗提供了新的选择。然而,需要进一步进行长期有效性和安全性的研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/faeaa46650cc/10238_2024_1468_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/b060c9be7204/10238_2024_1468_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/c50fc9b2eca3/10238_2024_1468_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/faeaa46650cc/10238_2024_1468_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/b060c9be7204/10238_2024_1468_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/c50fc9b2eca3/10238_2024_1468_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/502c/11442613/faeaa46650cc/10238_2024_1468_Fig3_HTML.jpg

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United European Gastroenterol J. 2023 Oct;11(8):722-732. doi: 10.1002/ueg2.12442. Epub 2023 Jul 20.
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Upadacitinib Salvage Therapy for Infliximab-Experienced Patients with Acute Severe Ulcerative Colitis.
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