Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.

IF 4.5 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Inflammatory Bowel Diseases Pub Date : 2024-12-05 DOI:10.1093/ibd/izae024

Bruce E Sands, Geert D'Haens, David B Clemow, Peter M Irving, Jordan T Johns, Theresa Hunter Gibble, Maria T Abreu, Scott Lee, Tadakazu Hisamatsu, Taku Kobayashi, Marla C Dubinsky, Severine Vermeire, Corey A Siegel, Laurent Peyrin-Biroulet, Richard E Moses, Joe Milata, Vipin Arora, Remo Panaccione, Axel Dignass

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Abstract

Background: Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical remission at week 12 (W12) and maintaining clinical remission at W52 in patients with moderately to severely active ulcerative colitis. Results are presented from the open-label extension study through W104.

Methods: Clinical, symptomatic, quality-of-life, and adverse event outcomes are reported for mirikizumab induction responders and extended induction responders, including biologic-failed patients, who entered LUCENT-3, with data shown for W52 maintenance responders or remitters. Discontinuations or missing data were handled by nonresponder imputation (NRI), modified NRI (mNRI), and observed case (OC).

Results: Among W52 mirikizumab responders, clinical response at W104 was 74.5%, 87.2%, and 96.7% and clinical remission was 54.0%, 62.8%, and 70.1% for NRI, mNRI, and OC, respectively. Among W52 mirikizumab remitters, clinical response at W104 was 76.6%, 89.0%, and 98.3% and clinical remission was 65.6%, 76.1%, and 84.2%. Using mNRI, remission rates at W104 for W52 clinical remitters were 74.7% corticosteroid-free, 79.5% endoscopic, 63.9% histologic-endoscopic mucosal remission, 85.9% symptomatic, 59.8% bowel urgency, 80.5% Inflammatory Bowel Disease Questionnaire (using NRI), 71.2% histologic-endoscopic mucosal improvement, and 77.5% bowel urgency improvement. Previous biologic-failed vs not-biologic-failed patient data were generally similar. Extended induction mNRI clinical response was 81.9%. Serious adverse events were reported in 5.2% of patients; 2.8% discontinued treatment due to adverse events.

Conclusions: Endoscopic, histologic, symptomatic, and quality-of-life outcomes support the long-term benefit of mirikizumab treatment up to 104 weeks in patients with ulcerative colitis, including biologic-failed patients, with no new safety concerns.

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米利珠单抗持续治疗溃疡性结肠炎 104 周后的两年疗效和安全性：LUCENT-3开放标签扩展研究的结果。

研究背景米利珠单抗是一种p19导向的白细胞介素-23单克隆抗体，能有效诱导中度至重度活动性溃疡性结肠炎患者在第12周（W12）出现临床缓解，并在第52周维持临床缓解。本文介绍了开放标签延伸研究至第 104 周的结果：方法：报告了进入LUCENT-3的米利珠单抗诱导应答者和延长诱导应答者（包括生物制剂失败患者）的临床、症状、生活质量和不良事件结果，并显示了W52维持应答者或缓解者的数据。停药或数据缺失通过无应答者估算（NRI）、修正的NRI（mNRI）和观察病例（OC）进行处理：在W52例mirikizumab应答者中，W104时的临床应答率分别为74.5%、87.2%和96.7%，临床缓解率分别为76.6%、89.0%和98.3%（NRI、mNRI和OC）。在W52米利珠单抗缓解者中，W104时的临床应答率分别为54.0%、62.8%和70.1%，临床缓解率分别为65.6%、76.1%和84.2%。使用 mNRI，W52 临床缓解者在 W104 期的缓解率为：74.7% 无皮质类固醇、79.5% 内镜缓解、63.9% 组织学内镜粘膜缓解、85.9% 无症状、59.8% 肠紧迫感、80.5% 炎症性肠病问卷调查（使用 NRI）、71.2% 组织学内镜粘膜改善、77.5% 肠紧迫感改善。既往生物治疗失败与非生物治疗失败患者的数据基本相似。延长诱导 mNRI 临床应答率为 81.9%。5.2%的患者出现严重不良反应；2.8%的患者因不良反应中断治疗：结论：内镜、组织学、症状和生活质量结果均支持米利珠单抗对溃疡性结肠炎患者（包括生物治疗失败的患者）的长期益处，且没有新的安全性问题。

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

Inflammatory Bowel Diseases 医学-胃肠肝病学

CiteScore

9.70

自引率

6.10%

发文量

462

审稿时长

1 months

期刊介绍： Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.