Through its research initiatives, Biogen aims to identify new ways to manage and monitor multiple sclerosis (MS) disease progression and provide physicians with real-world evidence to help inform treatment decisions. The following findings were presented at the 34th Congress of the European Committee for Treatment and Research in MS in Berlin, Germany (ECTRIMS; October 10-12):
- Data show serum neurofilament light (sNfL) is a potential biomarker of disease activity and treatment response.
- Results from MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions) support the use of technology to broadly monitor for clinically important outcomes, including cognitive changes.
- New analyses of ongoing studies continue to support the long-term benefits of TECFIDERA (dimethyl fumarate) and TYSABRI (natalizumab), particularly when initiating treatment early within the disease course.
Biomarker could guide MS treatment decisions
Biogen is engaged in research to evaluate sNfL, a protein that reflects neuronal damage and is elevated in the blood of people with MS, as a biomarker of disease activity. Results from a retrospective analysis of more than 1,000 patients support the clinical relevance of sNfL levels in the blood to predict disease severity and monitor treatment response in MS patients. Data indicate that sNfL levels above a certain threshold are associated with ongoing disease activity and negative clinical and radiologic outcomes, such as more disability progression and brain atrophy. Researchers also found that introducing disease-modifying therapies significantly reduced sNfL levels, and greater reduction was associated with better treatment outcomes.
“Our research suggests that serum neurofilament light is a promising biomarker that may predict a person’s disease course and help guide treatment decisions in MS,” said Peter Calabresi, director of the division of neuroimmunology and neuro-infectious diseases at the Johns Hopkins University School of Medicine. “These findings support sNfL as a clinically useful biomarker to help predict whether a person with MS is likely to have a fast-progressing or milder disease course. They also open the possibility of using a simple blood test to monitor whether a patient is responding to a specific treatment. The strong predictive power of sNfL may ultimately provide physicians with additional information beyond what is currently measured by MRI to help guide treatment decisions.”
Biogen is working to transition these results into a potentially valuable resource for clinical practice, and has expanded its collaboration with Siemens Healthineers to develop an sNfL blood test as an additional tool to monitor MS.
Real-world evidence reinforces long-term effectiveness of TECFIDERA and TYSABRI
Biogen continues to evaluate its MS therapies, TECFIDERA and TYSABRI, to better understand the benefits of using these treatments, including when initiated early within the disease and treatment course.
Results from the ENDORSE study demonstrate that the clinical benefits of TECFIDERA in reducing MS relapses and disability progression in newly diagnosed patients were maintained throughout nine years of continuous TECFIDERA treatment, with relapse rates remaining low and more than 90% of patients maintaining walking abilities. An analysis from the TYSABRI Observational Program, the largest ongoing, real-world study of TYSABRI-treated patients, reinforces the long-term safety and consistent effectiveness of TYSABRI over 10 years, especially for patients with minimal or mild disability and those who were previously treated with fewer disease-modifying therapies.
New technologies help monitor and manage MS
Through MS PATHS, a collaboration with 10 MS centres in Europe and the US, Biogen continues to leverage technology in routine care to collect clinical, MRI and biologic data from patients in real time, at the point of care. Using an iPad-based assessment, researchers are able to broadly monitor for changes in motor, visual and cognitive function. Cognitive deficits affect more than half of people living with MS, yet have not been regularly assessed in clinical practice and can be difficult to quantify. New MS PATHS data demonstrate that cognitive decline is as prevalent as physical decline in people with MS but can occur independently from physical symptoms. These results highlight the importance of monitoring cognition in routine care and the need for effective treatment strategies for cognitive changes in MS.
To help physicians outside of the MS PATHS network easily assess cognition in their patients, Biogen has developed CogEval, a free app available to healthcare providers in the US, Europe, Canada, Japan, Australia and New Zealand. Like the Processing Speed Test used in MS PATHS, CogEval is modelled after and validated against the Symbol Digit Modalities Test, regarded by many experts as the gold standard of MS cognitive screening tests. CogEval provides a two-minute, iPad-based assessment of cognitive function that depends on attention, psychomotor speed, visual processing and working memory.
“Through MS PATHS, Biogen is merging technology with routine care to broadly monitor for MS functional abilities, including cognition—a clinically meaningful aspect of disease progression on patients’ daily lives,” said Alfred Sandrock, executive vice president and chief medical officer at Biogen.