多发性硬化症患者皮下使用ocrelizumab:第3期OCARINA II研究的结果
Scott D Newsome1, Ewa Krzystanek2, Krzysztof W Selmaj3,4
1Johns Hopkins University School of Medicine, Baltimore, MD.
Neurology
|April 17, 2025
概括
在多发性硬化症患者中,皮下用ocrelizumab (OCR) 表明与静脉输入的OCR相比,药物暴露的程度不低. 这提供了可比的安全性和疗效概况,并提出了新的治疗选择.
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:
- 静脉注射ocrelizumab (OCR) 是一种用于复发性和初级渐进性多发性硬化症 (RMS/PPMS) 的成熟治疗方法.
- 该OCARINA II研究旨在比较皮下 (SC) OCR与静脉 (IV) OCR的药物暴露.
研究的目的:
- 为了证明皮下 (SC) 和静脉 (IV) 奥克雷利祖马布 (OCR) 之间药物暴露的非劣质性.
- 在多发性硬化症患者中评估SC与IV OCR的临床,生物标志物和安全结果.
主要方法:
- 第三阶段,随机化,开放标签研究OCR-naive患者 (18-65岁) 患有RMS/PPMS.
- 患者接受了OCR IV 600 mg或OCR SC 920 mg,然后每24周接受OCR SC 920 mg,直到96周.
- 主要终点:从第1天到第12周的血清度-时间曲线下的OCR区域 (AUCW1-12).
主要成果:
- 在AUCW1-12和AUCW1-24方面,OCR SC 920 mg与OCR IV 600 mg的非劣质性得到证明.
- 在这两只手臂中观察到MRI活动的几乎完全抑制 (T1和T2病变).
- 观察到可比的B细胞枯竭和血清神经丝轻链减少;不良事件主要是轻度/中度注射反应.
结论:
- 在药物暴露中,皮下用ocrelizumab (OCR SC) 配方显示与静脉注射ocrelizumab (OCR IV) 不相差.
- OCR SC提供了可比的疗效和安全性,为多发性硬化症提供了额外的治疗选择.
- 该研究提供了II类证据,支持SC OCR的疗效和安全性.
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