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

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2024-06-01 Epub Date: 2024-05-23 DOI:10.1007/s40261-024-01364-0
Chengu Niu, Jing Zhang, Mahesh Napel, Leela Krishna Teja Boppana, Hashem Anas, Nagesh Jadhav, Karin Dunnigan, Patrick I Okolo
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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.

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带 Meta 分析的系统性综述:乌达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。
背景:在炎症性肠病的治疗策略中,口服达帕替尼因其改善患者短期和长期预后的潜力而脱颖而出:在炎症性肠病的治疗策略中,口服奥达帕替尼因其改善患者短期和长期预后的潜力而脱颖而出:本荟萃分析旨在整理和评估现有的有关奥达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证据:荟萃分析采用的研究来自 MEDLINE/PubMed、Cochrane Library、Scopus 和 Embase,发表时间为 2010 年 1 月至 2024 年 3 月。根据既定的纳入和排除标准,纳入了报道达帕替尼对克罗恩病和溃疡性结肠炎成年患者疗效的同行评议文章:结果:共纳入了八项研究,包括2818名接受过达帕替尼治疗的患者。在主要结果方面,使用达达替尼的克罗恩病患者的加权汇总临床缓解率为45.8%(95%置信区间[CI] 0.39-0.52),而使用达达替尼的溃疡性结肠炎患者的临床缓解率为25.4%(95%置信区间[CI] 0.17-0.36)。克罗恩病的汇总临床应答率为53.6%(95% CI 0.50-0.57),溃疡性结肠炎的汇总临床应答率为72.6%(95% CI 0.69-0.76)。汇总的严重不良事件发生率为6.0%(95% CI 0.07-0.09):中重度克罗恩病和溃疡性结肠炎患者的临床缓解率和应答率分别为44.9%和36.0%,由此可见乌达替尼在实现临床缓解和应答方面具有显著疗效。该疗法还具有良好的安全性,严重不良事件发生率仅为 7.8%,是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的有效选择。
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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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