在复发性多发性硬化症中,ofatumumab的实际有效性和安全性:一项多中心队列研究
Katarina Tešija1, Magdalena Krbot Skorić2, Vanja Bašić Kes3
1University Hospital Center Zagreb, Department of Neurology, Zagreb, Croatia.
Multiple sclerosis and related disorders
|January 24, 2026
概括
在克罗地亚的复发性多发性硬化症 (pwMS) 患者中,ofatumumab显著降低了复发和MRI活性. 这项实践研究证实了其有效性和有利的安全概况,用于管理MS.
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:
- 复发性多发性硬化症 (MS) 需要有效和安全的治疗选择.
- 在临床试验中,Ofatumumab是一种B细胞消耗疗法,已经显示出有效性.
- 现实世界的数据对于确认不同患者群体的有效性和安全性至关重要.
研究的目的:
- 评估ofatumumab在克罗地亚复发性多发性硬化症 (pwMS) 患者的实际有效性.
- 在这个队列中评估ofatumumab的安全性和耐受性.
- 将现实世界的结果与关键试验结果进行比较.
主要方法:
- 在克罗地亚八家医院进行了回顾性观察性研究 (2022年3月至2025年3月).
- 收集了来自665个 pwMS 的临床,MRI 和实验室数据.
- 评估年度复发率 (ARR),MRI活动,残疾进展和不良事件.
主要成果:
- ARR显著下降,从0.70降至0.03 (p < 0.001).
- 76.7%的患者没有发现疾病活性的证据 (NEDA-3).
- 良好的安全性概况,停药率低 (4.2%) 和可管理的不良事件.
结论:
- 在克罗地亚的真实世界MS队列中,ofatumumab在减少复发和MRI活动方面表现出高效.
- 安全性概况是有利的,与关键试验结果一致.
- 在临床实践中,Ofatumumab是积极复发性MS的耐受性良好和有效的治疗选择.
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