Analysis of a potential blood biomarker linked to brain cell damage can help define disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).
Results of a study showed that determining blood levels of neurofilament light chain, or NfL, could help in establishing “no evidence of disease activity,” or NEDA, status in these patients — NEDA being a treatment target in RRMS.
The data will be presented at the 2018 Annual Meeting of the American Academy of Neurology (AAN), now taking place in Los Angeles through April 27. The presentation is titled “Including Blood Neurofilament Light Chain in the NEDA Concept in Relapsing–Remitting Multiple Sclerosis Trials.”
Multiple sclerosis (MS) is characterized by progressive degeneration of brain cells. This process promotes the release of NfL into the cerebral spinal fluid and blood. Previous studies have suggested that NfL levels could provide a reliable picture of activity of different forms of the disease. It could even be a valuable tool to monitor MS progression and response to treatment, instead of brain magnetic resonance imaging scans.
To further evaluate the diagnostic potential of blood NfL levels, a research team analyzed data collected from 214 RRMS patients who had participated in the Novartis-sponsored FREEDOMS trial (NCT00289978). During this Phase 3 clinical trial, patients were randomly treated with Gilenya (fingolimod) or placebo.
Scientists evaluated if adding brain volume loss (BVL) or NfL blood levels could increase the diagnostic potential of the standard disease activity score NEDA.
NEDA is used to identify patients with no significant clinical evidence of active disease. It is defined as a composite evaluation of the number of brain lesions and relapses, and disability progression within six months.
Data showed that 24%, 16%, and 20% of the patients achieved NEDA, NEDA-BVL, and NEDA-NfL, respectively, after two years of treatment. Of the 42 patients identified by NEDA-NfL score, 28 also had inactive disease as determined by NEDA-BVL.
Gilenya-treated patients were found to have 2.9 and 2.4 times higher probability of achieving NEDA and NEDA-BVL, compared to placebo, after two years of treatment. Adding NfL blood levels to NEDA scoring increased this probability to 3.5 times.
These results suggest that inclusion of NfL blood levels can help improve the sensitivity of the NEDA score system, “providing information on neurodegenerative aspects of MS in a similar way as BVL, and is simpler to assess,” the researchers wrote.
The NfL’s diagnostic potential has been validated in other studies that will also be subject of presentations at AAN 2018.