复发性复发性多发性硬化症患者的迪罗西梅尔烟酸:EVOLVE-MS-1第3期研究的最终安全性和有效性结果
Barry A Singer1, Douglas L Arnold2,3, Jelena Drulovic4
1The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.
Multiple sclerosis (Houndmills, Basingstoke, England)
|October 31, 2023
概括
在患有复发性缓解性多发性硬化症 (RRMS) 的患者中,二氧化胺 (DRF) 在两年内表现出良好的耐受性和安全性. 该研究显示疾病活性减少,支持DRF作为可行的治疗选择.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 迪罗西梅尔烟酸 (DRF) 已被批准用于复发性复发性多发性硬化症 (RRMS),并显示生物相当的活性代谢物暴露于二甲基烟酸 (DMF).
- 之前的研究表明,与DMF相比,DRF可能具有较少的胃肠道 (GI) 副作用.
研究的目的:
- 在复发性复发性多发性硬化症 (RRMS) 患者中报告迪罗西梅尔烟酸 (DRF) 的最终安全性,耐受性和疗效结果.
- 评估EVOLVE-MS-1第三阶段研究的长期结果.
主要方法:
- EVOLVE-MS-1是一项开放式的第三期研究,涉及96周的RRMS患者.
- 该研究主要评估了DRF的安全性和耐受性,以及探索性疗效终点.
主要成果:
- 超过75%的患者完成了96周的研究,平均暴露时间为1.8年.
- 88.7%的患者出现了不良事件 (AEs),大多为轻度或中度;仅有8.0%的患者因AEs而停止治疗,其中<2%为GI或与冲有关的问题.
- 在96周,加多增强性病变的显著减少 (72.7%) 和低调整年复发率 (0.13) 被观察到.
结论:
- 在RRMS患者中,二氧化胺 (DRF) 在两年内通常耐受良好,有限的副作用导致停止治疗.
- 放射学评估表明疾病活性下降,支持DRF作为RRMS治疗选择的作用.
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