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主要进展性多发性硬化症患者的ocrelizumab:一个现实世界的多中心研究

Magdalena Krbot Skorić¹, Vanja Bašić Kes², Nevena Grbić²

¹Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; Faculty of Electrical Engineering and Computing, University of Zagreb, Zagreb, Croatia.

Multiple sclerosis and related disorders

|July 24, 2024

概括

奥克雷利祖马布的现实数据显示,它在初级渐进性多发性硬化症 (PPMS) 患者中具有有效性和安全性. 研究结果支持该疗法超出临床试验标准的更广泛使用.

科学领域:

神经学神经学
免疫学免疫学免疫学
临床治疗学临床治疗学

背景情况:

奥克雷利祖马布是首发性渐进性多发性硬化症 (PPMS) 唯一批准的疾病修饰疗法 (DMT).
在更广泛的患者群体中,了解治疗有效性和安全性至关重要.

研究的目的:

评估ocrelizumab在患有原发性进展性多发性硬化症 (pwPPMS) 的人群中的实际有效性和安全性.
提供来自克罗地亚多发性硬化中心的证据,证明利祖马布在pwPPMS中使用.

主要方法:

追溯性,观察性,多中心研究,涉及使用ocrelizumab治疗的pwPPMS.
从克罗地亚的7个多发性硬化中心收集的数据,其中包括176名符合纳入标准的患者.
随访持续时间平均为2.73年,评估确认残疾恶化 (CDW) 和停止治疗.

主要成果:

50名 (28.4%) 患者经历了CDW,而19名 (10.8%) 患者停止了ocrelizumab.
基线扩展残疾状况尺度 (EDSS) >5预测的CDW或停药 (OR 2.482,p=0.015).
根据疾病活动,年龄,疾病持续时间或基线EDSS (≤5.0与>5.0) 观察到的结果没有显著差异.
副作用包括输液反应 (14.8%),感染 (36.4%) 和瘤 (2.3%). 在周期4后,观察到持续的低IgG和IgM水平.

结论:

现实世界的证据支持ocrelizumab在较广泛的pwPPMS患者中使用,而不是随机对照试验最初表明的.
在常规临床实践中,ocrelizumab在pwPPMS中显示出可管理的安全性.

关键词:

这就是Ocrelizumab.主要的渐进性多发性硬化症.现实世界的数据数据.

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