What is it about?
Disability status in multiple sclerosis (MS) is measured by a functional status scale called EDSS. It is an imperfect scale but is used extensively in research and is the only one accepted across the globe. MS drugs do NOT do a good job particularly when the disability scores hover between 3-4.5 and all approved MS drugs do NOT present data particularly when the disability scores show a worsening trend, i.e., 3-4.5 and beyond. In publications, only a passing reference is made to these critically important numbers.
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Why is it important?
It is critical that this data is known to the doctors or they would be choosing one over the other in a relatively blind approach. Also, drug companies are singularly lax in poor enrollment of African Americans and minority groups and consequently clinicians have no clue how to approach these patients with any degree of confidence.
Perspectives
FDA regulators must insist that data be presented for all drugs across ALL EDSS scores in a continuum. The data may not look pretty but it is what it is. Also, inclusion of African Americans in greater numbers (not a pitiful 2% or thereabouts) in clinical studies should be mandatory.
Dr Jagannadha R Avasarala
Greenville Memorial Hospital
Read the Original
This page is a summary of: Newer multiple sclerosis drugs and disability scores-are key data analyses missing?, The Journal of Clinical Pharmacology, June 2015, Wiley,
DOI: 10.1002/jcph.535.
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