Long-term effectiveness and safety of ustekinumab in patients with Crohn's disease: real-world evidence.

IF 4 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2025-09-01 Epub Date: 2025-09-04 DOI:10.1080/14712598.2025.2556909

Yumei Wu, Linlin Zhou, Mengqi Huang, Chengcheng Tian, Yu Wang, Qiming Huang, Jing Hu, Qiuyuan Liu, Juan Wu, Peipei Zhang, Qiao Mei, Wei Han

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引用次数: 0

Abstract

Background: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist approved for the treatment of Crohn's disease (CD). Although UST has demonstrated good efficacy and safety in CD, long-term real-world data in Chinese patients are relatively scarce.

Methods: A single-center, observational retrospective study was conducted in the First Affiliated Hospital of Anhui Medical University. Comprehensive baseline demographic characteristics, clinical parameters, potential predictors of clinical remission of CD patients treated with UST from January 2020 to January 2024 were collected and analyzed.

Results: A total of 348 CD patients were included. At week 52, the clinical remission rate was 70.95%, endoscopic remission 24.68%, C-Reactive Protein (CRP) normalization 54.11%, and fecal calprotectin (FCP) normalization 48.57%. Prior biologic exposure, CRP reduction at week 8, and baseline hemoglobin level were independent predictors of clinical remission. The mean survival duration with UST was 172 weeks (SE = 6, 95% CI: 160-185).

Conclusions: This study demonstrated favorable effectiveness, persistence, and safety of UST in CD patients. Prior biologic exposure, early CRP reduction and hemoglobin level were associated with clinical remission at 52 weeks.

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ustekinumab治疗克罗恩病患者的长期有效性和安全性：真实世界证据

背景：Ustekinumab （UST）是一种被批准用于治疗克罗恩病（CD）的白介素-12/白介素-23受体拮抗剂。尽管UST在CD治疗中表现出良好的疗效和安全性，但中国患者的长期真实数据相对缺乏。方法：在安徽医科大学第一附属医院进行单中心、回顾性观察研究。收集并分析2020年1月至2024年1月期间接受UST治疗的CD患者临床缓解的综合基线人口学特征、临床参数和潜在预测因素。结果：共纳入348例CD患者。第52周，临床缓解率为70.95%，内镜下缓解率为24.68%，c反应蛋白（CRP）正常化54.11%，粪钙保护蛋白（FCP）正常化48.57%。先前的生物暴露、第8周CRP降低和基线血红蛋白水平是临床缓解的独立预测因子。UST患者的平均生存时间为172周（SE = 6, 95% CI: 160-185）。结论：本研究证明了UST在CD患者中的良好有效性、持久性和安全性。先前的生物暴露、早期CRP降低和血红蛋白水平与52周的临床缓解相关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.