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Responsiveness of walking-based outcome measures after multiple sclerosis relapses following steroid pulses.

ABSTRACT: The aim of this study was to examine the impact of intravenous methylprednisolone therapy (IVMP) on the recovery of walking ability in patients experiencing multiple sclerosis (MS) relapses, to compare the responsiveness of walking-based measures, and to estimate the impact of different walking-based measures responsiveness on clinical trials.The study included 49 consecutive patients with relapsing-remitting MS who received Solu-Medrol 1000 mg/day over 3 days for relapse with difficulties in walking. The following walking-based measures were administered before and a month after IVMP: the Multiple Sclerosis Walking Scale-12 (MSWS-12), the Expanded Disability Status Scale (EDSS), the 2-minute timed walk (2-minTW), the 25-foot walk test (25FWT), the Six Spot Step Test (SSST). All patients had worn the step activity monitor accelerometer (SAM) 1 week prior to IVMP was applied and wore it again the fourth week upon the corticosteroid therapy was completed. The SAM analysis utilized the average daily step count and data regarding frequency and intensity of walking over a continuous time interval. We examined: (1) the impact of IVMP on the recovery of walking ability; (2) the responsiveness of each walking-based measure; (3) the relative responsiveness of competing walking-based measures; and (4) the impact of different walking-based measures responsiveness on clinical trials.All walking-based measures showed significant improvement of walking ability 1 month after the IVMP. The most responsive were MSWS-12 and EDSS. Different responsiveness implied a greater than 6-fold impact on sample size estimates.All applied walking-based measures showed significant improvement of walking ability 1 month after the IVMP. Responsiveness of various walking-based measures notably differ, thus affecting sample size calculations.

SUBMITTER: Filipovic Grcic P

PROVIDER: S-EPMC3628135 | biostudies-other | 2011 Dec

REPOSITORIES: biostudies-other

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Responsiveness of walking-based outcome measures after multiple sclerosis relapses following steroid pulses.

Filipović Grčić Petar P Matijaca Meri M Lušić Ivo I Čapkun Vesna V

Medical science monitor : international medical journal of experimental and clinical research 20111201 12

<h4>Background</h4>The aim of this study was to examine the impact of intravenous methylprednisolone therapy (IVMP) on the recovery of walking ability in patients experiencing multiple sclerosis (MS) relapses, to compare the responsiveness of walking-based measures, and to estimate the impact of different walking-based measures responsiveness on clinical trials.<h4>Material/methods</h4>The study included 49 consecutive patients with relapsing-remitting MS who received Solu-Medrol 1000 mg/day ove ...[more]

PMID: 22129902

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Project description:ObjectiveIntravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse; however, this fails to improve symptoms in up to one quarter of patients. Immunoadsorption is an accepted treatment for refractory relapses, but prospective comparator-controlled studies are missing.MethodsIn this observational study, patients with steroid-refractory acute multiple sclerosis relapses receiving either six courses of tryptophan-immunoadsorption or double-dose methylprednisolone therapy were analysed. Outcomes were evaluated at discharge and three months later. Immune profiling of blood lymphocytes and proteomic analysis were performed by multi-parameter flow cytometry and Olink analysis, respectively (NCT04450030).Results42 patients were enrolled (methylprednisolone: 26 patients; immunoadsorption: 16 patients). For determination of the primary outcome, treatment response was stratified according to relative function system score changes ("full/best" vs. "average" vs. "worse/none"). Upon discharge, the adjusted odds ratio for any treatment response ("full/best" + "average" vs. "worse/none") was 10.697 favouring immunoadsorption (p = 0.005 compared to methylprednisolone). At follow-up, the adjusted odds ratio for the best treatment response ("full/best" vs. "average" + "worse/none") was 103.236 favouring IA patients (p = 0.001 compared to methylprednisolone). Similar results were observed regarding evoked potentials and quality of life outcomes, as well as serum neurofilament light-chain levels. Flow cytometry revealed a profound reduction of B cell subsets following immunoadsorption, which was closely correlated to clinical outcomes, whereas methylprednisolone had a minimal effect on B cell populations. Immunoadsorption treatment skewed the blood cytokine network, reduced levels of B cell-related cytokines and reduced immunoglobulin levels as well as levels of certain coagulation factors.InterpretationImmunoadsorption demonstrated favourable outcomes compared to double-dose methylprednisolone. Outcome differences were significant at discharge and follow-up. Further analyses identified modulation of B cell function as a potential mechanism of action for immunoadsorption, as reduction of B cell subsets correlated with clinical improvement.

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Responsiveness of walking-based outcome measures after multiple sclerosis relapses following steroid pulses.

Publications

Responsiveness of walking-based outcome measures after multiple sclerosis relapses following steroid pulses.

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