Lars G Hvid1,2, Egon Stenager3,4, Ulrik Dalgas5. 1. Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, Aarhus, Denmark. lhvid@ph.au.dk. 2. The Danish MS Hospitals, Ry and Haslev, Denmark. lhvid@ph.au.dk. 3. Department of Regional Health Research, University of Southern Denmark, Odense, Denmark. 4. Department of Neurology, MS-Clinic of Southern Jutland (Sønderborg, Esbjerg, Kolding), Sønderborg, Denmark. 5. Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, Aarhus, Denmark.
Abstract
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.
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.
Authors: Luis Ruano; Emilio Portaccio; Benedetta Goretti; Claudia Niccolai; Milton Severo; Francesco Patti; Sabina Cilia; Paolo Gallo; Paola Grossi; Angelo Ghezzi; Marco Roscio; Flavia Mattioli; Chiara Stampatori; Maria Trojano; Rosa Gemma Viterbo; Maria Pia Amato Journal: Mult Scler Date: 2016-10-13 Impact factor: 6.312