Through its research initiatives, Biogen Idec aims to identify new ways to manage and monitor multiple sclerosis (MS) disease progression and provide clinicians with real-world evidence to help inform treatment decisions. Data show serum neurofilament light (sNfL) is a potential biomarker of disease activity and treatment response,1,2 and 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.5 New analyses of ongoing studies continue to support the long-term benefits of dimethyl fumarate and natalizumab, particularly when initiating treatment early within the disease course.3,4
These findings were presented at the 34th Congress of the European Committee for Treatment and Research in MS in Berlin, Germany (ECTRIMS; 10-12th October 2018).
Biogen remains committed to investing in MS and pursuing research efforts to advance our understanding of the disease, including aspects that matter most to patients. We are generating data that have led to the development of new tools for everyday clinical practice and which inform personalised decisions with the aim of improving patient outcomes.
Michael Ehlers, executive vice president, research & development at Biogen
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.1 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.1 Researchers also found that introducing disease-modifying therapies significantly reduced sNfL levels, and greater reduction was associated with improved treatment outcomes, compared to placebo.1,2
“There are currently no blood biomarkers for treatment monitoring in MS,” said Peter Calabresi, M.D., director of the Division of Neuroimmunology and Neuro-infectious Diseases at the Johns Hopkins University School of Medicine. “These findings confirm 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 clinicians with additional information beyond what is currently measured by MRIs to help guide treatment decisions.”
Biogen is working to transition these results into a 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. An assay will allow clinicians to measure sNfL levels in the blood of MS patients with the goals of better understanding disease activity and monitoring treatment response.
Real-World Evidence Reinforces Long-Term Effectiveness of Dimethyl Fumarate and Natalizumab
Biogen recognises the importance of real-world evidence to help guide decisions in clinical practice and optimise patient care. The company continues to evaluate its MS therapies, dimethyl fumarate for the treatment of relapsing remitting MS (RRMS) and natalizumab for highly active RRMS, to better understand the benefits of using these treatments as indicated, including when initiated early within the disease and treatment course.
Results from the ENDORSE study demonstrate that the clinical benefits of dimethyl fumarate were maintained throughout nine years of continuous dimethyl fumarate treatment.3 An analysis from the TYSABRI Observational Program (TOP), the largest ongoing, real-world study of natalizumab-treated patients, reinforces the long-term benefit:risk profile and consistent effectiveness of natalizumab over 10 years, especially for patients who were previously treated with fewer disease-modifying therapies.4
New Technologies Help Monitor and Manage MS
Through MS PATHS, a collaboration with 10 leading MS centres in Europe and the U.S., 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.5 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.6 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.5 These results underscore the importance of monitoring cognition in routine care and the need for effective treatment strategies for cognitive changes in MS.
To help clinicians outside of the MS PATHS network to easily assess cognition in their patients, Biogen has developed CogEval, a free app available to healthcare providers in the U.S., Europe (including UK), Canada, Japan, Australia and New Zealand. Like the Processing Speed Test used in MS PATHS, CogEval is modeled after and validated against the Symbol Digit Modalities Test. 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, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We are pleased to bring this technology to clinicians outside of the MS PATHS network through the development of solutions like the CogEval app, which we hope will help clinicians more easily assess cognitive function in clinical practice.”
1 Calabresi P, et al. Serum Neurofilament Light (NfL) for Disease Prognosis and Treatment Monitoring in Multiple Sclerosis Patients: Is it Ready for Implementation into Clinical Care? ECTRIMS 2018, 10-12 Oct. 2018.
2 Fox R, et al. Temporal Relationship of Serum Neurofilament Light Levels and Radiological Disease Activity in Patients with Multiple Sclerosis. ECTRIMS 2018, 10-12 Oct. 2018.
3 Gold R, et al. Delayed-release Dimethyl Fumarate Demonstrates Sustained Efficacy over Nine Years in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis. ECTRIMS 2018, 10-12 Oct. 2018.
4 Kappos L, et al. Real-world data from over 10 years in the TYSABRI Observational Program long-term safety and effectiveness of natalizumab in relapsing-remitting multiple sclerosis patients. ECTRIMS 2018, 10-12 Oct. 2018.
5 Williams JR, et al. Prevalence of Isolated Cognitive Decline in a Large Heterogeneous Multiple Sclerosis Population. ECTRIMS 2018, 10-12 Oct. 2018.
6 Multiple Sclerosis International Federation (MSIF). 2013. MS in focus: MS and cognition. Available at: https://www.msif.org/wp-content/uploads/2014/09/MS-in-focus-22-Cognition-English1.pdf. Last accessed: 10 Oct. 2018.