Contributions
Abstract: 237
Type: Oral
Biomarkers, in general, and candidates from the CSF in particular, could potentially serve several purposes. They could provide assistance in identifying individuals who will develop MS; or predict prognosis in those who do have MS; or help to define patients who will respond better to particular treatments. Although the presence of oligoclonal bands may help predict conversion to MS among patients with clinically isolated syndromes, no CSF (or serum) biomarker has yet been validated for use in defining either progression or therapeutic response, the subject of this debate. Much attention has been given to a number of CNS specific proteins, particularly to markers of axonal death and gliosis. However, even the candidate biomarkers perhaps most widely touted, neurofilament light and neurofilament heavy, have so far been found wanting. Similarly, measurement of variety of antibodies has failed to show consistent, reproducible, or clinically useful results. Over the past 5 years, numerous extensive reviews on biomarkers in MS have been published and, invariably, the authors have concluded that none has demonstrated either convincing clinical utility or sufficient validation to be trustworthy in clinical trials. Even Professor Giovannoni, himself, in a 2014 review in the Handbook of Clinical Neurology concluded, “
the value of measuring
CSF constituents for both diagnostic and prognostic purposes and for following response to therapy is still to be determined.” In 2016, unfortunately, that lack of determination remains true, as no biomarker has been subjected to a sufficiently powered, multi-center trial to establish its utility. As Horsley et al, in their 2015 extensive review on biomarkers concluded, “Until these studies are completed, it is unlikely that an MS biomarker will be sufficiently verified to become clinically relevant.”
Disclosure: Dr. Miller has received research support from BiogenIdec, Genzyme/sanofi,Mallinckrodt (Questcor), Novartis, Roche/Genentech; has served as a consultant for Accordant Health Services (Caremark), Acorda Therapeutics, Alkermes, BiogenIdec, EMD Serono, Genzyme/sanofi, Mallinckrodt (Questcor), Novartis, Roche/Genentech; and is a member of the Speakers Bureau (unbranded programs only) for BiogenIdec and Roche/Genentech.
Abstract: 237
Type: Oral
Biomarkers, in general, and candidates from the CSF in particular, could potentially serve several purposes. They could provide assistance in identifying individuals who will develop MS; or predict prognosis in those who do have MS; or help to define patients who will respond better to particular treatments. Although the presence of oligoclonal bands may help predict conversion to MS among patients with clinically isolated syndromes, no CSF (or serum) biomarker has yet been validated for use in defining either progression or therapeutic response, the subject of this debate. Much attention has been given to a number of CNS specific proteins, particularly to markers of axonal death and gliosis. However, even the candidate biomarkers perhaps most widely touted, neurofilament light and neurofilament heavy, have so far been found wanting. Similarly, measurement of variety of antibodies has failed to show consistent, reproducible, or clinically useful results. Over the past 5 years, numerous extensive reviews on biomarkers in MS have been published and, invariably, the authors have concluded that none has demonstrated either convincing clinical utility or sufficient validation to be trustworthy in clinical trials. Even Professor Giovannoni, himself, in a 2014 review in the Handbook of Clinical Neurology concluded, “
the value of measuring
CSF constituents for both diagnostic and prognostic purposes and for following response to therapy is still to be determined.” In 2016, unfortunately, that lack of determination remains true, as no biomarker has been subjected to a sufficiently powered, multi-center trial to establish its utility. As Horsley et al, in their 2015 extensive review on biomarkers concluded, “Until these studies are completed, it is unlikely that an MS biomarker will be sufficiently verified to become clinically relevant.”
Disclosure: Dr. Miller has received research support from BiogenIdec, Genzyme/sanofi,Mallinckrodt (Questcor), Novartis, Roche/Genentech; has served as a consultant for Accordant Health Services (Caremark), Acorda Therapeutics, Alkermes, BiogenIdec, EMD Serono, Genzyme/sanofi, Mallinckrodt (Questcor), Novartis, Roche/Genentech; and is a member of the Speakers Bureau (unbranded programs only) for BiogenIdec and Roche/Genentech.