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系统评价与荟萃分析:乌帕替尼在治疗中重度克罗恩病和溃疡性结肠炎的疗效和安全性。

Systematic Review with Meta-analysis: Efficacy and Safety of Upadacitinib in Managing Moderate-to-Severe Crohn's Disease and Ulcerative Colitis.

机构信息

Internal Medicine Residency Program, Rochester General Hospital, 1425 Portland Avenue, Rochester, NY, 14621, USA.

Rainier Springs, Vancouver, WA, USA.

出版信息

Clin Drug Investig. 2024 Jun;44(6):371-385. doi: 10.1007/s40261-024-01364-0. Epub 2024 May 23.

DOI:10.1007/s40261-024-01364-0
PMID:38777970
Abstract

BACKGROUND

In the panorama of therapeutic strategies for inflammatory bowel diseases, oral upadacitinib stands out for its potential to improve short-term and long-term patient outcomes.

OBJECTIVE

This meta-analysis aspires to collate and assess the available evidence regarding the efficacy and safety of upadacitinib in managing moderate-to-severe Crohn's disease and ulcerative colitis.

METHODS

A meta-analysis was conducted using studies sourced from MEDLINE/PubMed, Cochrane Library, Scopus, and Embase, published from January 2010 to March 2024. Peer-reviewed articles that reported data on the effects of upadacitinib in adult patients with Crohn's disease and ulcerative colitis were included based on established inclusion and exclusion criteria.

RESULTS

Eight studies, encompassing a total of 2818 patients treated with upadacitinib, were included. In primary outcomes, for patients with Crohn's disease who were using upadacitinib, the weighted pooled clinical remission rate was found to be 45.8% (95% confidence interval [CI] 0.39-0.52), while for patients with ulcerative colitis who were using upadacitinib, the rate was 25.4% (95% CI 0.17-0.36). The pooled clinical response rate for Crohn's disease was 53.6% (95% CI 0.50-0.57), and for ulcerative colitis it was 72.6% (95% CI 0.69-0.76). The pooled serious adverse event rate was 6.0% (95% CI 0.07-0.09).

CONCLUSIONS

Upadacitinib demonstrates significant efficacy in achieving clinical remission and response in patients with moderate-to-severe Crohn's disease and ulcerative colitis, as shown by clinical remission rates of 44.9% and 36.0%, respectively. The treatment also maintains a favorable safety profile with a serious adverse event rate of 7.8%, making it an effective option for those resistant or intolerant to traditional immunosuppressants or tumor necrosis factor antagonists.

摘要

背景

在炎症性肠病的治疗策略中,口服乌帕替尼因其有可能改善患者的短期和长期预后而脱颖而出。

目的

本荟萃分析旨在收集和评估乌帕替尼治疗中重度克罗恩病和溃疡性结肠炎的疗效和安全性的现有证据。

方法

检索 MEDLINE/PubMed、Cochrane 图书馆、Scopus 和 Embase 自 2010 年 1 月至 2024 年 3 月发表的研究,采用荟萃分析。根据既定的纳入和排除标准,纳入了报告乌帕替尼治疗克罗恩病和溃疡性结肠炎成年患者疗效数据的同行评议文章。

结果

纳入了 8 项研究,共纳入 2818 例接受乌帕替尼治疗的患者。在主要结局方面,对于使用乌帕替尼的克罗恩病患者,加权汇总的临床缓解率为 45.8%(95%置信区间 [CI] 0.39-0.52),而对于使用乌帕替尼的溃疡性结肠炎患者,缓解率为 25.4%(95% CI 0.17-0.36)。克罗恩病的临床应答率为 53.6%(95% CI 0.50-0.57),溃疡性结肠炎为 72.6%(95% CI 0.69-0.76)。严重不良事件的汇总发生率为 6.0%(95% CI 0.07-0.09)。

结论

乌帕替尼在治疗中重度克罗恩病和溃疡性结肠炎患者方面显示出显著疗效,分别达到临床缓解率 44.9%和 36.0%,临床应答率为 53.6%和 72.6%。该治疗方案的严重不良事件发生率为 7.8%,安全性良好,为那些对传统免疫抑制剂或肿瘤坏死因子拮抗剂耐药或不耐受的患者提供了一种有效的治疗选择。

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N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.
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Insights into adverse events and safety profile of upadacitinib in the management of inflammatory bowel diseases - A meta-analysis of randomized controlled trials.乌帕替尼治疗炎症性肠病的不良事件及安全性剖析——一项随机对照试验的荟萃分析
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