在多发性硬化症中使用ocrelizumab的延长剂量间隔.
Frederik Novak1,2, Hamza Mahmood Bajwa1,2, Kamilla Østergaard3
1Department of Neurology, Esbjerg Hospital, University Hospital of Southern Denmark, Esbjerg, Denmark.
概括
延长多发性硬化症 (MS) 患者的ocrelizumab剂量间隔平均9周,没有显示出临床或生物标志物恶化. 这种延长剂量间隔 (EID) 方法与标准剂量间隔 (SID) 相比,维持了治疗疗效.
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) 管理包括向治疗,如ocrelizumab.
- 优化剂量计划,例如标准间隔剂量 (SID) 与延长间隔剂量 (EID),对于患者的治疗结果和治疗坚持至关重要.
- 研究EID与SID对ocrelizumab的临床和生物标志物影响对于完善MS治疗策略至关重要.
研究的目的:
- 为了比较在多发性硬化症中接受ocrelizumab标准间隔剂量 (SID) 和延长间隔剂量 (EID) 的患者之间的临床和生物标志物结果.
- 评估延长ocrelizumab治疗间隔的安全性和有效性.
- 为了评估EID和SID组之间的B细胞水平,ocrelizumab血清度,神经丝轻链 (NFL) 和状纤维酸蛋白 (GFAP) 水平的差异.
主要方法:
- 这是一项前性,多中心的开放性研究,涉及184名患有多发性硬化症的参与者,他们接受了超过12个月的ocrelizumab治疗.
- 参与者被分为EID (n=107) 和SID (n=77) 组,EID平均延长9周.
- 结果包括MRI疾病活动,复发,神经状态恶化和没有疾病活动证据-3 (NEDA-3),以及生物标志物分析 (B细胞,ocrelizumab,NFL,GFAP).
主要成果:
- 与标准间隔剂量 (SID) 相比,延长间隔剂量 (EID) 显示了较高的B细胞计数和较低的ocrelizumab血清度.
- 根据年龄调整的神经纤维光链 (NFL) 和质纤维酸蛋白 (GFAP) 水平在两组之间没有显著差异.
- 结合的终点没有疾病活动的证据-3 (NEDA-3) 在EID和SID组之间没有差异 (危险比:1.174,p=0.69).
- 较高的NFL水平与疾病活性有关,身体质量指数与ocrelizumab和B细胞水平相关.
结论:
- 将ocrelizumab治疗间隔平均延长9周 (长达78周) 并没有导致MS患者的临床,放射学或生物标志物恶化的证据.
- 在这个队列中,延长间隔剂量 (EID) 似乎保持了与标准间隔剂量 (SID) 相比的治疗疗效.
- 进一步的研究可能会探索多发性硬化症管理中的长期结果和个性化EID策略.
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