An evaluation of mirikizumab for the treatment of ulcerative colitis.

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2024-10-16 DOI:10.1080/14712598.2024.2412650

Christopher White, Peter M Irving

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引用次数: 0

Abstract

Introduction: Treatment of ulcerative colitis (UC) aims to reduce symptoms and complications by decreasing intestinal inflammation. A proportion of patients do not respond to, do not tolerate, or are inappropriate candidates for current therapies. Interleukin (IL)-23 is a therapeutic target and mirikizumabis the first p19-targeted IL-23 antibody approved for the treatment of moderately to severely active UC.

Areas covered: This review summarizes the pro-inflammatory effects of IL-23 and outlines the pharmacokinetics of mirikizumab. It provides a synopsis of the available phase II and phase III evidence for the efficacy and safety of mirikizumab in UC.

Expert opinion: The mirikizumab clinical development program demonstrated its superiority over placebo and its favorable safety profile in the treatment of UC. Its positioning in therapeutic algorithms remains to be fully understood but mirikizumab has proven efficacy in both advanced therapy (AT)-naïve and AT-experienced patients. The inclusion in the license of extended induction for non-responders as well as rescue intravenous dosing allows for flexibility in patient with limited primary response and secondary loss of response.

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米利珠单抗治疗溃疡性结肠炎的评估。

导言：治疗溃疡性结肠炎（UC）的目的是通过减少肠道炎症来减轻症状和并发症。一部分患者对目前的疗法没有反应、不能耐受或不适合。白细胞介素（IL）-23是一种新型治疗靶点，米利珠单抗是首个获准用于治疗中度至重度活动性UC的抗IL-23抗体：本综述总结了IL-23的促炎作用，并概述了米利珠单抗的药代动力学。本综述概述了米利珠单抗治疗UC的II期和III期疗效和安全性证据：米利珠单抗的临床开发项目证明了其在治疗UC方面优于安慰剂的疗效和良好的安全性。米利珠单抗在治疗方案中的定位仍有待全面了解，但已证明米利珠单抗对晚期治疗（AT）无效和有AT治疗经验的患者均有疗效。许可证中包含了对无应答者的延长诱导治疗以及静脉给药抢救治疗，这为原发反应有限和继发反应消失的患者提供了灵活性。

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.