在初级进展性多发性硬化症中使用ocrelizumab的有效性:多中心,回顾性,现实世界的研究 (OPPORTUNITY)
Clara G Chisari1, Assunta Bianco2, Vincenzo Brescia Morra3
1Department of Medical and Surgical Sciences and Advanced Technologies "G.F. Ingrassia, " University of Catania, Via S. Sofia 78, 95100, Catania, Italy.
概括
在标准试验标准之外的患者中,ocrelizumab有效治疗初级渐进性多发性硬化症 (PPMS). 65岁以上的老年患者显示,确诊残疾恶化的风险更高.
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:
- 奥克雷利祖马布是一种针对CD20的单克隆抗体,已被批准用于初级渐进性多发性硬化症 (PPMS).
- 第三阶段试验评估了Ocrelizumab在55岁以下的PPMS患者中,扩展残疾状态量表 (EDSS) ≤6.5.
- 对于年龄较大,残疾较大或疾病持续时间较长的患者的疗效仍然不太清楚.
研究的目的:
- 评估ocrelizumab在不符合ORATORIO试验资格标准的PPMS患者的临床有效性.
- 评估不符合ORATORIO标准的患者是否受益于ocrelizumab治疗.
主要方法:
- 一项多中心回顾性研究分析了意大利多发性硬化中心 (2017年5月至2022年6月) 的数据.
- 包括589名接受了ocrelizumab治疗的PPMS患者,比较那些符合 (n=149) 和超出 (n=440) ORATORIO标准的患者.
- 确认EDSS恶化 (CEW) 在12个月和24个月是主要的结果指标.
主要成果:
- 在ORATORIO和非ORATORIO组之间没有观察到12个月和24个月CEW概率 (≤1点) 的显著差异.
- 65岁以上的年龄与24个月后CEW的风险明显增加有关 (HR 2.51).
- 起始时的疾病活动,持续时间和EDSS并没有显著影响非ORATORIO组的残疾结果.
结论:
- 在ORATORIO试验标准之外,ocrelizumab治疗似乎对PPMS患者有益.
- 65岁以上的年龄是残疾恶化的危险因素,尽管治疗.
- 应该考虑将ocrelizumab的使用扩展到65岁以下的选择PPMS患者中,这些患者不符合目前的报销标准.
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