Following the news (20th February 2019) that, according to a study published in the journal Neurology, blood neurofilament light chain can be a biomarker of multiple sclerosis (MS) disease activity and treatment response, Alessio Brunello, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:
“Finding a biomarker in MS that translates into clinical meaningfulness has been a real challenge for the field of biomarkers in the central nervous system (CNS). The current way to diagnose MS is through MRI and tests of cerebrospinal fluid (CSF) that must be collected via lumbar puncture; however these procedures are invasive and expensive.
“In about 85% of patients, MRIs can be very specific for the diagnosis of MS, mainly due to the central vein sign and the Dawson’s finger. Only around 15% of patients do not show those characteristics and for those patients, it can be challenging trying to determine a diagnosis of MS versus the mimics of the disease.
“Neurofilament light (NfL) is some of the most promising biomarkers for MS as they have potential to monitor ongoing neurodegeneration and axonal injury. In MS, there are 13 FDA-approved disease-modifying therapies and biomarkers are useful for determining which therapy to use and in which different patient populations it’s a key area.
“One of the most useful aspects of NfL biomarkers is the potential to use them as a prognostic biomarker in clinical trials for progressive MS and also correlate with treatment response to natalizumab, fingolimod and rituximab.
“Data that has emerged in the last year has been very encouraging. NfL is the most interesting molecule that is going to be in use in routine management of patients before the end 2019.
“There is a great unmet need for simple, inexpensive, and non-invasive tests that could be applied to screen MS and there is also a need of having sensitive assays available to use in a clinical setting and biomarkers that monitor ongoing disease activity. Currently no biomarker has been approved for MS and some of the real challenges of biomarkers in MS are introducing new tests into a costly system.”