Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, Aarhus, Denmark.
The Danish MS Hospitals, Ry and Haslev, Denmark.
J Neurol. 2022 Sep;269(9):4895-4908. doi: 10.1007/s00415-022-11134-7. Epub 2022 Apr 28.
In persons with multiple sclerosis (pwMS), little evidence exist on the effects of Alemtuzumab on physiological, physical, and cognitive function along with patient-reported outcomes, despite these domains are being rated as highly important. Therefore, our purpose was to perform a prospective observational study to examine these outlined outcomes during the first two years of Alemtuzumab treatment in pwMS.
In n = 17 relapsing-remitting pwMS, physiological function [body composition; bone mineral content; muscle strength; aerobic capacity], physical function [6-min walk test (6MWT, primary outcome); timed 25 ft walk test (T25FWT); six spot step test (SSST); 9-step stair ascend (9SSA); timed up and go test (TUG); 5 × sit to stand test (5STS)], cognitive function [selective reminding test (SRT); symbol digit modalities test (SDMT)], and patient-reported outcomes [multiple sclerosis impact scale-29 (MSIS29); 12-item multiple sclerosis walking scale (MSWS12); modified fatigue impact scale (MFIS); hospital anxiety and depression scale (HADS)] were assessed prior to Alemtuzumab treatment initiation as well as 3, 6, 12, and 24 months into the treatment.
Improvements were observed at 24-month follow-up in T25FWT (+ 8%), SSST (+ 10%), SDMT (+ 5.2 points, 53% improved more than the clinical cut-off score) and SRT, whereas the primary outcome 6MWT, and all other remaining outcomes, remained stable throughout the Alemtuzumab treatment period.
The present findings suggest that Alemtuzumab treatment in relapsing-remitting pwMS can improve certain domains of physical function (short distance walking) and cognitive function (processing speed, memory), and furthermore stabilize physiological and physical function along with patient-reported outcomes.
Registered at clinicaltrials.gov: NCT03806387.
在多发性硬化症患者(pwMS)中,尽管这些领域被认为非常重要,但关于 Alemtuzumab 对生理、身体和认知功能以及患者报告的结果的影响的证据很少。因此,我们的目的是进行一项前瞻性观察研究,在 pwMS 接受 Alemtuzumab 治疗的头两年内检查这些概述的结果。
在 17 名复发缓解型 pwMS 中,生理功能[身体成分;骨矿物质含量;肌肉力量;有氧能力]、身体功能[6 分钟步行测试(6MWT,主要结果);定时 25 英尺步行测试(T25FWT);六步台阶测试(SSST);9 步楼梯上升(9SSA);计时起立行走测试(TUG);5 次坐立站起测试(5STS)]、认知功能[选择性提醒测试(SRT);符号数字模态测试(SDMT)]和患者报告的结果[多发性硬化症影响量表-29(MSIS29);12 项多发性硬化症步行量表(MSWS12);改良疲劳影响量表(MFIS);医院焦虑和抑郁量表(HADS)]在 Alemtuzumab 治疗开始前以及治疗 3、6、12 和 24 个月时进行评估。
在 24 个月的随访中,T25FWT(+8%)、SSST(+10%)、SDMT(+5.2 分,53%的人改善超过临床截止分数)和 SRT 得到改善,而主要结果 6MWT 和所有其他剩余结果在 Alemtuzumab 治疗期间保持稳定。
目前的研究结果表明,Alemtuzumab 治疗复发缓解型 pwMS 可以改善某些身体功能(短距离行走)和认知功能(处理速度、记忆力)领域,此外还可以稳定生理和身体功能以及患者报告的结果。
在 clinicaltrials.gov 上注册:NCT03806387。