在稳定多发性硬化症患者中停止一线疾病修饰疗法:DOT-MS随机临床试验
Eline M E Coerver1, Wing Hee Fung1, Janet de Beukelaar2
1Multiple Sclerosis Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam University Medical Center location VUmc, Amsterdam, the Netherlands.
JAMA neurology
|December 9, 2024
概括
在患有长期稳定疾病的患者中,停止多发性硬化症的疾病修饰疗法 (DMT) 导致炎症性疾病活动的复发率更高. 这表明在考虑停止MS治疗时需要谨慎.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
背景情况:
- 多发性硬化症 (MS) 管理越来越多地涉及疾病修饰疗法 (DMT).
- 对于DMT的长期疾病稳定性,需要考虑由于负担,成本和副作用而中止治疗.
研究的目的:
- 评估在长期稳定的多发性硬化症患者中停止一线DMT的安全性.
- 为了确定MS患者在一线DMT上稳定超过5年,是否可以安全地停止治疗.
主要方法:
- 一个多中心,评级盲,非劣等性随机临床试验,涉及89名患有复发性MS的参与者.
- 参与者被随机分配到停止或继续第一线DMT.
- 主要结局被定义为显著的炎症性疾病活动 (复发或特定的MRI发现).
主要成果:
- 该试验因停药组中复发性炎症性疾病活动而过早终止.
- 停止服用DMT的45名参与者中有8人 (17.8%) 经历了炎症活动,而继续服用的44名参与者中没有人出现炎症活动.
- 这种复发率高于之前的研究,特别是在年轻人群中.
结论:
- 在患有长期稳定的多发性硬化症 (甚至超过5年) 的患者中,停止一线DMT可以导致炎症性疾病活动的显著复发.
- 调查结果强调,在考虑戒除DMT时,需要仔细考虑和共同决策.
- 这项研究增加了宝贵的数据,特别是对于年轻的多发性硬化症患者来说,关于停止治疗的风险.
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