患有中度至重度活跃性性结肠炎的患者的奥贝法齐莫德:从96周的开放性维护阶段2b研究中进行的疗效和安全性分析
Severine Vermeire1, Josianne Nitcheu2, Paul Gineste2
1Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Journal of Crohn's & colitis
|May 26, 2025
概括
在患有性结肠炎的患者中,Obefazimod在96周内表现出持续的疗效和良好的安全性. 长期使用奥贝法齐莫德 (每天服用50毫克一次) 治疗在UC管理方面显示出有前途的结果.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
背景情况:
- 奥贝法齐莫德是一种口服小分子,可以选择性地增强微RNA (miRNA),miR-124表达.
- 之前的2b阶段诱导试验显示了obefazimod在中度至严重的性结肠炎 (UC) 中的安全性和有效性.
- 本研究介绍了一项开放式维护 (OLM) 研究的两年结果数据.
研究的目的:
- 评估obefazimod在中度至重度UC患者的长期疗效和安全性.
- 评估96周维持治疗的临床和内镜结果.
主要方法:
- 来自2b期试验的患者进入了96周的OLM研究,每天接受一次ofefazimod 50 mg.
- 安全性通过定期的临床检查进行监测.
- 在第48周和第96周使用非响应者归算缺失数据来评估有效性.
主要成果:
- 在217名注册患者中,164名 (75.6%) 完成了96周的治疗.
- 观察到高临床响应率 (81.6%在第48周, 72.8%在第96周) 和缓解率 (54.8%在第48周, 52.5%在第96周).
- 内镜改善和缓解率也显著,在96周内没有出现新的安全风险.
结论:
- 这项为期96周的OLM研究证实了奥贝法齐莫德50毫克每天服用一次的长期疗效和良好的安全性.
- 奥贝法齐莫德对中度至重度UC患者来说是一个有前途的治疗选择.
- 目前正在进行第三阶段计划,以进一步评估Obefazimod在这个患者群体中的作用.
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