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mirikizumab:克罗恩病治疗中的一项有前景的突破。

Mirikizumab: A promising breakthrough in Crohn's disease treatment.

作者信息

Aslam Muaaz, Ali Mohammad Haris, Irfan Hamza

机构信息

Department of Medicine Shaikh Khalifa Bin Zayed Al Nahyan Medical and Dental College Lahore Punjab Pakistan.

出版信息

Health Sci Rep. 2024 Aug 6;7(8):e2294. doi: 10.1002/hsr2.2294. eCollection 2024 Aug.

Abstract

INTRODUCTION

Crohn's disease (CD) is a chronic, progressive inflammatory bowel disorder characterized by persistent inflammation and noncontiguous "skip lesions" throughout the gastrointestinal tract. With a prevalence of 100-300 cases per 100,000 individuals, CD is most common in Western Europe and North America. Symptoms include abdominal pain, diarrhea, fever, weight loss, and anemia, with severe cases leading to complications such as perianal abscesses and cutaneous fistulas. Treatment involves pharmaceutical interventions, bowel rest, and sometimes surgery, with biological therapies like ustekinumab and mirikizumab gaining prominence.

CLINICAL TRIALS

The VIVID-1 trial assessed mirikizumab in patients with moderately to severely active CD. By Week 12, mirikizumab significantly outperformed placebo in clinical response (45.4% vs. 19.6%,  < 0.000001). By Week 52, it showed higher clinical remission rates (54.1% vs. 19.6%) and demonstrated non-inferiority to ustekinumab in clinical remission ( = 0.51). The SEQUENCE study compared risankizumab to ustekinumab, with risankizumab showing superior reductions in inflammatory markers and higher biologic remission rates at Weeks 8, 24, and 48. Both treatments had similar safety profiles, with common adverse events including COVID-19, anemia, and headache.

CONCLUSION

Mirikizumab, based on the VIVID-1 trial outcomes, is a promising addition to CD therapy. It demonstrated significant clinical responses and remission rates, warranting further research on its long-term efficacy and safety. Updating professional guidelines and addressing affordability will ensure broader access and improved management of CD.

摘要

引言

克罗恩病(CD)是一种慢性进行性炎症性肠病,其特征为整个胃肠道持续存在炎症以及非连续性“跳跃性病变”。CD的患病率为每10万人中有100 - 300例,在西欧和北美最为常见。症状包括腹痛、腹泻、发热、体重减轻和贫血,严重病例会导致肛周脓肿和皮肤瘘等并发症。治疗方法包括药物干预、肠道休息,有时还需要手术,像乌司奴单抗和mirikizumab等生物疗法越来越受到关注。

临床试验

VIVID - 1试验评估了mirikizumab在中度至重度活动性CD患者中的疗效。到第12周时,mirikizumab在临床反应方面显著优于安慰剂(45.4%对19.6%,<0.000001)。到第52周时,它显示出更高的临床缓解率(54.1%对19.6%),并且在临床缓解方面显示出不劣于乌司奴单抗(=0.51)。SEQUENCE研究将risankizumab与乌司奴单抗进行了比较,risankizumab在第8周、24周和48周时炎症标志物降低更为显著,生物缓解率更高。两种治疗方法的安全性相似,常见不良事件包括新冠病毒感染、贫血和头痛。

结论

基于VIVID - 1试验结果,mirikizumab是CD治疗中有前景的补充药物。它显示出显著的临床反应和缓解率,有必要对其长期疗效和安全性进行进一步研究。更新专业指南并解决可及性问题将确保更广泛地获得CD治疗并改善其管理。

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