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一个随机的双盲,安慰剂对照试验低剂量介质素-2在复发性复发性多发性硬化症

C Louapre¹, M Rosenzwajg^2,3, M Golse¹

¹Sorbonne University, Paris Brain Institute - ICM, Assistance Publique Hôpitaux de Paris, Inserm, CNRS, Hôpital de la Pitié Salpêtrière, Department of Neurology, CIC neurosciences, Paris, France.

Journal of neurology

|May 28, 2023

概括

针对多发性硬化症 (MS) 的低剂量互白素-2 (IL2_LD) 疗法显示,调控性T细胞 (Tregs) 的延迟增加和激活的表型. 需要进一步的研究来探索其在MS治疗中的潜力.

科学领域:

免疫学免疫学免疫学
神经免疫学神经免疫学
临床试验临床试验

背景情况:

多发性硬化症 (MS) 的特征是调节性T细胞 (Treg) 不足.
已知低剂量互白素-2 (IL2_LD) 激活Tregs并降低各种自身免疫疾病中的疾病活性.

研究的目的:

研究IL2_LD在改善Treg功能中的有效性,在患有复发性复发性MS的患者中.
评估IL2_LD对MS患者Treg扩张和表型的影响.

主要方法:

一个单中心,双盲,第二阶段研究 (MS-IL2) 涉及30个复发性复发性MS患者.
随机 1:1分配给安慰剂或每日IL2_LD (1百万 IU) 5天,然后每两周一次给药6个月.
主要终点:Treg数量在第5天的变化;二次评估包括Treg表型和MRI病变数量.

主要成果:

在IL2_LD组中,在第15天观察到Treg扩张,而不是第5天 (安慰剂中中间折叠变化为1.26与1.01,p<0.001).
在IL2_LD组中,Tregs在第5天表现出激活的表型 (CD25表达折叠变化为2.17与安慰剂中的0.97,p<0.0001).
在IL2_LD组中,调节剂/效应剂T细胞的比率仍然较高;减少病变和复发的趋势被注意到,但在统计学上并不显著.

结论:

与其他自身免疫性疾病相比,IL2_LD对MS患者的Tregs的影响是适度的和延迟的.
结果表明Tregs可能在MS复髓化中发挥作用,支持进一步的研究.
对于MS,建议进行更大规模的研究,使用修改IL2_LD剂量或管理.

关键词:

免疫调节免疫调节免疫抑制是一种免疫抑制.免疫治疗是一种免疫疗法.神经退行发生神经退行.神经炎症是一种神经炎症.宽容是一种宽容.

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