纳塔利祖马布和奥克雷祖马布对多发性硬化症疾病进展的比较
Pietro Iaffaldano1, Giuseppe Lucisano2, Tommaso Guerra1
1Department of Translational Biomedicines and Neurosciences, University of Bari Aldo Moro, Bari, Italy.
Annals of clinical and translational neurology
|July 6, 2024
概括
这项研究发现,在未经治疗的多发性硬化症患者中,在纳塔利祖马布和ocrelizumab之间,无论复发活性 (PIRA) 或残疾里程碑,在短期进展风险上没有显著差异. 这两种疗法都有效地抑制了复发相关恶化 (RAW) 事件.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 关于不依赖复发活动 (PIRA) 的进展和复发相关恶化 (RAW) 的natalizumab和ocrelizumab的直接比较缺乏.
- 了解治疗对不同疾病进展途径的影响对于治疗多发性硬化症至关重要.
研究的目的:
- 为了比较前6个月确认的PIRA和RAW事件的风险,先前接受过纳塔利祖马布治疗的MS患者与ocrelizumab相比.
- 评估和比较这些治疗组之间不可逆转的扩大残疾状况尺度 (EDSS) 4.0和6.0里程碑的风险.
主要方法:
- 分析了来自意大利多发性硬化病登记处的一组从未接受过治疗的多发性硬化症患者的队列,这些患者开始接受纳塔利祖马布或奥克雷祖马布治疗.
- 为了平衡基线特征,采用双向倾向得分匹配,然后采用多变量Cox比例危险模型来估计事件风险.
- 卡普兰-梅尔曲线可视化了达到PIRA,RAW和EDSS进展结果的累积概率.
主要成果:
- 在倾向分数匹配 (195对) 后,在纳塔利祖马布和奥克雷祖马布之间的PIRA事件风险 (HR 1.04,P=0.88) 或不可逆转的EDSS 4.0 (HR 1.23,P=0.60) 和EDSS 6.0 (HR 0.93,P=0.89) 中没有发现显著差异.
- 复发相关恶化 (RAW) 事件很少见,在纳塔利祖马布组没有报告,在奥克雷祖马布组只有一个.
结论:
- 纳塔利祖马布和奥克雷祖马布都在以前MS患者中抑制RAW事件方面表现出强烈的疗效.
- 在短期内,这两种治疗都没有在PIRA事件的风险或达到EDSS 4.0和6.0里程碑方面显示出统计学上显著的差异.
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