奥克雷利祖马布和奥法图穆马布的比较:一项意大利现实世界倾向得分匹配研究
Aurora Zanghì1, Giovanna Borriello2, Simona Bonavita3
1Department of Medical and Surgical Sciences, University of Foggia, 71122, Foggia, Italy.
Journal of neurology
|May 4, 2024
概括
奥克雷利祖马布 (OCR) 和奥法图穆马布 (OFA) 在治疗复发性多发性硬化症 (MS) 中表现出相似的有效性,在现实研究中显示出类似的疾病活动控制和良好的安全性.
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:
- 高效疾病修饰疗法 (DMT) 的出现,特别是像ocrelizumab (OCR) 和ofatumumab (OFA) 这样的抗CD20单克隆抗体,已经彻底改变了多发性硬化症 (MS) 管理.
- 这些先进疗法为患有复发性多发性硬化症 (RMS) 患者提供了改善的疾病控制.
研究的目的:
- 为了比较ocrelizumab (OCR) 与ofatumumab (OFA) 在复发性MS (RMS) 患者的疗效和安全性.
- 评估治疗结果,包括年复发率 (ARR) 和12个月没有疾病活性的证据 (NEDA-3).
主要方法:
- 一项独立的回顾性队列研究,涉及8个意大利MS中心的396名RMS患者.
- 患者开始接受OCR或OFA治疗,并被跟踪至少12个月.
- 用通用线性回归与治疗权重的逆概率 (IPTW) 来分析ARR,并收集了NEDA-3和安全性数据.
主要成果:
- 在OCR和OFA组之间没有观察到年度复发率 (ARR) 的显著差异 (p=0.185).
- 经IPTW调整的分析证实了OCR和OFA之间的可比治疗效果 (ExpBOFA 0.974,p=0.207).
- 在12个月后,在两组中都实现了高无证据疾病活动-3 (NEDA-3) 率 (OCR为92.1%,OFA为94.4%,p=0.368),对两种DMT的总体耐受性良好.
结论:
- 奥克雷利祖马布 (OCR) 和奥法图穆马布 (OFA) 在RMS患者中提供了可比的疾病活性控制.
- 这两种抗CD20疗法都表现出良好的安全性.
- 需要在更大,长期的多中心研究中进一步验证.
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