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生物制剂与乌帕替尼联合用于难治性炎症性肠病的高级联合疗法:一项来自台湾的回顾性研究。

Advanced Combination Therapy with Biologics and Upadacitinib in Refractory Inflammatory Bowel Disease: A Retrospective Study from Taiwan.

作者信息

Meng Ming-Jung, Kuo Chia-Jung, Lai Ming-Wei, Chiu Cheng-Tang, Su Ming-Yao, Chang Ming-Ling, Le Puo-Hsien

机构信息

Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Taoyuan, Taiwan.

Chang Gung Inflammatory Bowel Disease Center, Taoyuan, Taiwan.

出版信息

J Inflamm Res. 2025 Feb 26;18:2733-2742. doi: 10.2147/JIR.S511309. eCollection 2025.

Abstract

BACKGROUND

Refractory inflammatory bowel disease (IBD) remains challenging despite the availability of various biologics. Advanced combination therapy (ACT) with biologics and Upadacitinib (UPA), a rapid-onset oral selective Janus kinase inhibitor, has shown promise in managing refractory IBD. However, its use in Asia has not been explored. This study aims to fill that gap by providing data from Taiwan.

MATERIALS AND METHODS

This retrospective study included refractory IBD patients who received ACT with biologics and UPA, followed up at the Chang Gung Inflammatory Bowel Disease Center from July 2020 to August 2024. Patients were assessed for clinical response and remission at weeks 4, 12, and 24. Safety profiles were monitored throughout the follow-up period to evaluate the risk of adverse events.

RESULTS

Sixteen refractory IBD patients were enrolled. The median disease duration was 4.5 years [IQR 2.25-9.50]. The most common regimen was Ustekinumab plus UPA (63%). Clinical response rates at weeks 4, 12, and 24 were 88%, 83%, and 100%, respectively, while remission rates were 31%, 50%, and 80%. One patient (6.25%) experienced a minor adverse event (acne), with no major events like herpes zoster reactivation or major cardiac complications.

CONCLUSION

This is the first study in Asia to demonstrate that UPA-based ACT is both effective and safe in treating refractory IBD. However, the limitations of this retrospective, single-center study with a relatively small sample size highlight the need for future larger-scale, multi-center prospective studies to confirm these findings, identify predictors of treatment response, and evaluate long-term outcomes.

摘要

背景

尽管有多种生物制剂可供使用,但难治性炎症性肠病(IBD)仍然具有挑战性。生物制剂与乌帕替尼(UPA,一种起效迅速的口服选择性 Janus 激酶抑制剂)的先进联合疗法(ACT)在治疗难治性 IBD 方面已显示出前景。然而,其在亚洲的应用尚未得到探索。本研究旨在通过提供来自台湾的数据填补这一空白。

材料与方法

这项回顾性研究纳入了 2020 年 7 月至 2024 年 8 月在长庚炎症性肠病中心接受生物制剂与 UPA 联合 ACT 治疗的难治性 IBD 患者。在第 4、12 和 24 周对患者进行临床反应和缓解评估。在整个随访期间监测安全性,以评估不良事件风险。

结果

纳入 16 例难治性 IBD 患者。疾病中位病程为 4.5 年[四分位间距 2.25 - 9.50]。最常见的方案是优特克单抗加 UPA(63%)。第 4、12 和 24 周的临床反应率分别为 88%、83%和 100%,而缓解率分别为 31%、50%和 80%。1 例患者(6.25%)发生轻微不良事件(痤疮),未发生带状疱疹再激活或重大心脏并发症等重大事件。

结论

这是亚洲第一项证明基于 UPA 的联合 ACT 在治疗难治性 IBD 方面既有效又安全的研究。然而,这项回顾性、单中心且样本量相对较小的研究的局限性凸显了未来需要进行更大规模、多中心前瞻性研究以证实这些发现、确定治疗反应的预测因素并评估长期结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eed8/11872097/537ad1988f45/JIR-18-2733-g0001.jpg

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