评估多发性硬化症患者从纳塔利祖马布转换为奥克雷祖马布 (OCTAVE) 的疗效和安全性
Kyle Smoot1, Horia Marginean1, Tiffany Gervasi-Follmar1
1Providence Brain and Spine Institute, Portland, OR, USA.
概括
大多数复发性多发性硬化症 (RMS) 患者在从纳塔利祖马布 (natalizumab) 过渡到奥克雷祖马布 (ocrelizumab) 时保持稳定,显示临床和MRI稳定性. 这项研究评估了ocrelizumab在RMS患者的安全性和有效性,这些患者之前接受过natalizumab治疗.
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:
- 多发性硬化症 (MS) 的纳塔利祖马布治疗带有渐进式多焦点脑白内障 (PML) 的风险,特别是在感染约翰·坎宁汉病毒 (JCV) 的患者中.
- 奥克雷利祖马布是一种有效的多发性硬化症治疗方法,但其在先前接受过纳塔利祖马布治疗的患者中的安全性需要研究.
研究的目的:
- 评估ocrelizumab在复发性多发性硬化症 (RMS) 患者的安全性和疗效,这些患者之前曾接受过natalizumab治疗.
- 为了确定从纳塔利祖马布过渡到奥克雷祖马布是否在RMS患者中保持临床和放射性稳定性.
主要方法:
- 该研究招募了临床和放射性稳定的RMS患者 (18-65岁),接受了超过12个月的纳塔利祖马布治疗.
- 在最后一剂纳塔利祖马布服用后4-6周开始服用奥克雷利祖马布,评估包括复发评估,扩展残疾状况尺度和大脑MRI,定期间隔长达12个月.
主要成果:
- 在43名注册患者中,有41人 (95%) 完成了该研究.
- 两名患者经历了没有MRI变化的复发,另外两名患者在没有新的症状的情况下出现了新的MRI病变.
- 记录了13起严重不良事件 (SAE),其中4起可能与ocrelizumab有关.
结论:
- 在大多数RMS患者中,从纳塔利祖马布过渡到ocrelizumab通常保持了临床和MRI稳定性.
- 奥克雷利祖马布似乎是以前用纳塔利祖马布治疗的RMS患者的安全和有效选择,需要进一步调查.
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