Highlights
- •SLCMSR challenged established outcome parameters in MS.
- •Sustained increase of EDSS appeared to be an invalid outcome for clinical trials.
- •SLCMSR contributed to the development of new outcomes such as real-world walking speed.
- •A tool was constructed to provide individual prognostic estimates based on a matching algorithm.
Abstract
The SLCMSR was formed as an international Multiple Sclerosis Trials, Research and
Resource Center to identify clinical MRI and other predictors of the course of multiple
sclerosis (MS) based on a large database of natural history and clinical trial data.
Using an elaborate validation concept several key findings were published, challenging
established outcome parameters and their assessment in MS such as disability ratings
with Expanded Disability Status Scale (EDSS), relapses and MRI endpoints. Sustained
increase of EDSS appeared to be an invalid outcome for 2–3 year clinical trials at
least in patients with relapsing-remitting MS. The number of gadolinium-enhancing
lesions and T2-lesion load on MRI were shown not to have a meaningful additional predictive
value for the disease course. These issues risen some 15 years ago had triggered controversial
discussions which have also been noticed by regulatory authorities and they all have
not been resolved. In addition the SLCMSR contributed to the development of new outcomes
such as real-world walking speed as an attractive, ecologically valid tool based on
a wearable device. A so-called evidence-based-decision-support tool was constructed
to provide individual prognostic estimates based on a matching algorithm to a given
database. This paper condensates the findings of 20 years of critical MS research.
Keywords
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Biography
Heesen 2013
Kosch 2021
Article info
Publication history
Published online: May 16, 2022
Accepted:
May 13,
2022
Received in revised form:
March 31,
2022
Received:
January 9,
2022
Identification
Copyright
© 2022 Published by Elsevier B.V.
