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托法替布在全国退伍军人事务部溃疡性结肠炎患者队列中的长期有效性和安全性

Long-Term Effectiveness and Safety of Tofacitinib in a Nationwide Veterans Affairs Cohort of Ulcerative Colitis Patients.

作者信息

Khan Nabeel, Sundararajan Ramaswamy, Mahmud Nadim

机构信息

Department of Gastroenterology, Corporal Michael J Crescenz VA Medical Center, Philadelphia, PA, USA.

Division of Gastroenterology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.

出版信息

Crohns Colitis 360. 2025 Jul 9;7(3):otaf037. doi: 10.1093/crocol/otaf037. eCollection 2025 Jul.

DOI:10.1093/crocol/otaf037
PMID:40678548
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12267814/
Abstract

BACKGROUND

There is limited real-world data on the long-term effectiveness and safety of tofacitinib among ulcerative colitis (UC) patients, especially among the elderly. Our aim was to evaluate these parameters among UC patients who had remained on the drug 1 year after initiation of therapy.

METHODS

We conducted a retrospective cohort study, utilizing the US National Veterans Affairs Healthcare System, including patients with UC who received tofacitinib. The primary endpoint was effectiveness at the end of follow-up. The secondary endpoint was to evaluate if the effectiveness was different among the elderly compared to the young. Adverse events associated with the drug, like herpes zoster, major adverse cardiovascular events, deep vein thrombosis, as well as infections and malignancy during follow-up were also assessed.

RESULTS

In total, 159 patients were included in the study, among whom 51 were in the elderly group and 108 were in the younger group. The median duration of follow-up was 1.47 years (range, 0.01-5.49 years). Effectiveness of tofacitinib among the cohort was 56.60% (90 out of 159 patients). The effectiveness was higher in the elderly ( = .005).

CONCLUSION

In this nationwide cohort of UC patients, the effectiveness of tofacitinib was seen in a little over half the number of patients, with higher rates of effectiveness reported among the elderly. No new safety concerns were raised, especially among the elderly.

摘要

背景

关于托法替布在溃疡性结肠炎(UC)患者,尤其是老年患者中的长期有效性和安全性,现实世界的数据有限。我们的目的是评估在开始治疗1年后仍继续使用该药物的UC患者中的这些参数。

方法

我们利用美国国家退伍军人事务医疗保健系统进行了一项回顾性队列研究,纳入接受托法替布治疗的UC患者。主要终点是随访结束时的有效性。次要终点是评估老年人与年轻人相比有效性是否存在差异。还评估了与该药物相关的不良事件,如带状疱疹、主要不良心血管事件、深静脉血栓形成,以及随访期间的感染和恶性肿瘤。

结果

该研究共纳入159例患者,其中老年组51例,年轻组108例。中位随访时间为1.47年(范围为0.01 - 5.49年)。托法替布在该队列中的有效性为56.60%(159例患者中的90例)。老年人的有效性更高(P = 0.005)。

结论

在这个全国性的UC患者队列中,略超过半数的患者显示出托法替布的有效性,老年人中的有效性率更高。未出现新的安全问题,尤其是在老年人中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c3f/12267814/8618278819d8/otaf037_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c3f/12267814/8618278819d8/otaf037_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c3f/12267814/8618278819d8/otaf037_fig1.jpg

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本文引用的文献

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Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure.在接受药物治疗长达 9.2 年的全球临床开发项目中,对托法替布治疗溃疡性结肠炎的安全性进行分析。
United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22.
2
Effectiveness of Tofacitinib in Patients With Ulcerative Colitis: A Nationwide Veterans Administration Cohort Study.托法替布治疗溃疡性结肠炎患者的有效性:一项全国退伍军人管理局队列研究
Am J Gastroenterol. 2024 Apr 5;119(8):1632-5. doi: 10.14309/ajg.0000000000002761.
3
Clinical and Endoscopic Outcomes Through 78 Weeks of Tofacitinib Therapy for Ulcerative Colitis in a US Cohort.
美国队列研究中托法替尼治疗溃疡性结肠炎 78 周的临床和内镜结局。
Inflamm Bowel Dis. 2024 Oct 3;30(10):1707-1713. doi: 10.1093/ibd/izad242.
4
Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety.溃疡性结肠炎中托法替尼的真实世界证据:短期和长期疗效及安全性。
Am J Gastroenterol. 2023 Jul 1;118(7):1237-1247. doi: 10.14309/ajg.0000000000002145. Epub 2022 Dec 14.
5
Effectiveness and safety of tofacitinib for ulcerative colitis: two-year results of the ICC Registry.托法替布治疗溃疡性结肠炎的疗效和安全性:ICC 注册研究的两年结果。
Aliment Pharmacol Ther. 2023 Jan;57(1):117-126. doi: 10.1111/apt.17248. Epub 2022 Oct 25.
6
Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open-label, long-term extension study with up to 7.0 years of treatment.托法替布治疗溃疡性结肠炎的安全性和疗效:OCTAVE Open 的最终分析,一项开放性、长期扩展研究,治疗时间长达 7.0 年。
Aliment Pharmacol Ther. 2022 Feb;55(4):464-478. doi: 10.1111/apt.16712. Epub 2021 Dec 1.
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Real-World Efficacy and Safety Monitoring for Predicting Continuation of Tofacitinib Therapy in Patients with Ulcerative Colitis.真实世界疗效和安全性监测预测溃疡性结肠炎患者托法替布治疗的持续。
Dig Dis Sci. 2022 Aug;67(8):3984-3992. doi: 10.1007/s10620-021-07233-6. Epub 2021 Aug 30.
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Inflamm Bowel Dis. 2022 Jan 5;28(1):32-40. doi: 10.1093/ibd/izab011.
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