Neurology: Reliability of secondary progressive multiple sclerosis clinical trials

Multiple sclerosis (MS) is an autoimmune disease in which the central nervous system's white inflammatory demyelination becomes a major feature.
The most commonly affected areas of the disease are the whiteness, optic nerve, spinal cord, brain thymus and small brain around the brain chamber, the main clinical characteristics are the central nervous system white mass scattered in the distribution of multiple lesions and pathogenes shown in the relapse, symptoms and signs of spatial multiple and the time of the disease is multiple.
the age of the disease is more than 20 to 40 years old, under 10 years of age and over 50 years of age patients are rare, the ratio of male to female disease is about 1:2.
The American Society for Multiple Sclerosis in 1996 classified the disease as relapsed-remission-remission (RRMS), secondary progression (SPMS), primary progression (PPMS) and progressive hair (PRMS), of which the division was related to the treatment decision of MS.
, as a progressive neurodegenerative disease, there is no treatment that can effectively relieve SPMS.
, the progress of disability in SPMS trials was measured primarily by stable and reliable changes in the walking-based Extended Disability Status Scale (EDSS).
two previous large randomized controlled trials (RPTs) showed that timed 25-foot walk (T25FW) had a higher rate of progress than EDSS as part of the MS Functional Comprehensive Assessment (MSFC).
, some researchers believe that T25FW is more suggestive than EDSS in SPMS clinical trials.
, choosing the most appropriate primary outcome is the key to accurately measuring progress with MS disability.
to study the reliability of clinical outcomes in SPMS trials, neurologists from the University of Calgary in Canada compared the frequency of different clinical outcomes in two large RCTs data to measure progress and improve events.
results were published in the journal Neurology.
researchers used two large RCTs original trial data using IMPACT (International MS Secondary Progressive Controlled Trial) and ASCEND (clinical study of the efficacy of Nataliju monoantigen resistance in reducing disability progression in participants with secondary progressive multiple sclerosis).
the progress of disability and improvements in similar definitions for 3 or 6 months EDSS, T25FW, 9-Hole Peg Test (9HPT) and their combinations.
the results found that in both data set, EDSS had the highest improvement rate, the smallest difference between progress and improvement rate over time, followed by T25FW and 9HPT.
the improvement rates of T25FW and 9HPT are fairly stable over time and remain below 10% or about.
in the case of EDSS, the improvement rate and the disability progress rate increased simultaneously.
results show that in SPMS, the results of all surveys show some evidence of random variation and measurement errors, and that T25FW and 9HPT are more stable than mature EDSS.
results are of great significance to the design and evaluation of SPMS tests.
: Marcus W. Koch, et al. Reliability of Outcome Measures in Clinical Trials in Secondary Progressive Multiple Sclerosis. Neurology Jan 2021, 96 (1) e111-e120; DOI: 10.1212/WNL.00000000000000011123MedSci Original Source: MedSci Original Copyright Notice: All noted on this website Source: Met Medical Or "Source: MedSci Original" text, images and audio-visual materials, copyrights are owned by Metz Medicine, without authorization, no media, website or individual may reproduce, authorized to reproduce with the words "Source: Mets Medicine".
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