TY - JOUR
T1 - Objectively assessed physiological, physical, and cognitive function along with patient-reported outcomes during the first 2 years of Alemtuzumab treatment in multiple sclerosis
T2 - a prospective observational study
AU - Hvid, Lars G.
AU - Stenager, Egon
AU - Dalgas, Ulrik
N1 - Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
PY - 2022/9
Y1 - 2022/9
N2 - Introduction: 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. Methods: 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. Results: 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. Conclusion: 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. Trial registration: Registered at clinicaltrials.gov: NCT03806387.
AB - Introduction: 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. Methods: 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. Results: 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. Conclusion: 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. Trial registration: Registered at clinicaltrials.gov: NCT03806387.
KW - Cognitive function
KW - Disease-modifying treatment
KW - Immunomodulation
KW - Multiple sclerosis
KW - Patient-reported outcomes
KW - Physical function
KW - Humans
KW - Cognition
KW - Multiple Sclerosis
KW - Walking/physiology
KW - Time and Motion Studies
KW - Postural Balance
KW - Alemtuzumab/therapeutic use
KW - Patient Reported Outcome Measures
U2 - 10.1007/s00415-022-11134-7
DO - 10.1007/s00415-022-11134-7
M3 - Journal article
C2 - 35482080
AN - SCOPUS:85128903370
SN - 0340-5354
VL - 269
SP - 4895
EP - 4908
JO - Journal of Neurology
JF - Journal of Neurology
ER -