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在患有多发性硬化症的患者中使用迪罗西梅尔 fumarate 的现实世界经验:一项前性的多中心研究

Clara Aguirre¹, Ana Alonso-Torres², Eduardo Agüera³

¹Neurology Department, Hospital Universitario de La Princesa, Calle de Diego de León, 62, 28006, Madrid, Spain. claraguih@hotmail.com.

Clinical drug investigation

|October 28, 2024

概括

迪罗西梅尔烟酸 (DRF) 在现实世界多发性硬化症 (MS) 治疗中显示出良好的安全性和耐受性. 初步证据表明,DRF是有效的,在MS患者中复发率低,残疾进展稳定.

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) 建议在多发性硬化症 (MS) 治疗中比二甲基烟酸 (DMF) 更安全.
关于DRF在MS治疗中的有效性,现实世界数据有限.
本研究涉及DRF在现实环境中的安全性,耐受性和有效性.

研究的目的:

为了评估diroximel fumarate (DRF) 在现实世界多发性硬化症 (MS) 患者队列中的安全性和耐受性.
评估DRF在MS中管理临床和放射性疾病活动中的有效性.
从西班牙国家登记处收集患者开始DRF治疗的数据.

主要方法:

采用了一个多中心,前性观察性研究设计.
收集了来自195名多发性硬化患者的数据,这些患者在26个神经学部门开始DRF治疗.
监测人口和临床特征,安全结果 (不良事件,中止原因,淋巴细胞计数) 和疗效结果 (放射学和临床活动).

主要成果:

包括195名多发性硬化患者 (79.5%为女性,平均年龄为42.17) 中,DRF治疗的平均持续时间为6.3个月.
70.3%的人没有报告任何不良事件;胃肠道问题和冲是最常见的.
84.6%的人继续使用DRF;耐受性是停止的主要原因. 观察到复发率低,EDSS得分稳定/改善,放射性活动最小.

结论:

现实数据证实了多氧化烟酸 (DRF) 在多发性硬化症 (MS) 管理中的安全性和耐受性.
初步证据表明,DRF在控制疾病活动方面表现出有效性.
这项研究为DRF在MS患者的实际应用提供了宝贵的见解.

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