Biogen Advances Research to Improve Outcomes for Patients With
Multiple Sclerosis
Through its research initiatives, Biogen Inc. (Nasdaq: BIIB)
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. Data show serum
neurofilament light (sNfL) is a potential biomarker of disease
activity and treatment response, 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. 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. These findings are being presented at the 34th
Congress of the European Committee for Treatment and Research in MS
in Berlin, Germany (ECTRIMS; October 10-12).
“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,” said Michael
Ehlers, executive vice president, research & development at
Biogen. “We are generating data that have led to the development of
new tools for everyday clinical practice and which inform
personalized decisions with the aim of improving patient
outcomes.”
Biomarker Could Guide MS Treatment
DecisionsBiogen 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,
M.D., 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 MRIs 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. A highly sensitive,
robust and validated assay will allow physicians to measure sNfL
levels in the blood of MS patients with the goal of better
understanding disease activity and monitoring treatment
response.
Real-World Evidence Reinforces Long-Term Effectiveness
of TECFIDERA and TYSABRIBiogen recognizes the importance
of real-world evidence to help guide decisions in clinical practice
and optimize patient care. The company continues to evaluate its
leading 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 percent of patients maintaining
walking abilities. An analysis from the TYSABRI Observational
Program (TOP), 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 leading MS centers 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. 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.1
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 underscore 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 U.S., Europe, 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, 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, Jr., M.D., Ph.D.,
executive vice president and chief medical officer at Biogen. “We
are pleased to bring this technology to physicians outside of the
MS PATHS network through the development of innovative solutions
like the CogEval app, with the aim of helping physicians more
easily assess cognitive function in clinical practice.”
Featured data presentation
details:
- Temporal Relationship of Serum Neurofilament Light Levels and
Radiological Disease Activity in Patients with Multiple Sclerosis –
Poster P532 – Wednesday, 10 October, 17:00-19:00 CET
- Prevalence of Isolated Cognitive Decline in a Large,
Heterogeneous Multiple Sclerosis Population – Poster P517 –
Wednesday, 10 October, 17:00-19:00 CET
- Serum Neurofilament Light (sNfL) for Disease Prognosis and
Treatment Monitoring in Multiple Sclerosis Patients: Is it Ready
for Implementation into Clinical Care? – Platform 5 – Thursday, 11
October, 11:16-11:28 CET
- 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 –
Poster P908 – Thursday, 11 October, 17:15-19:15 CET
- Delayed-release Dimethyl Fumarate Demonstrates Sustained
Efficacy over Nine Years in Newly Diagnosed Patients with
Relapsing-Remitting Multiple Sclerosis – Poster P920 – Thursday, 11
October, 17:15-19:15 CET
- Benchmarks of Manual Dexterity and Walking Speed in a Large,
Representative Patient Population – Poster P1018 – Friday, 12
October, 12:15-14:15 CET
About TECFIDERA® TECFIDERA is an oral therapy
for relapsing forms of MS, including relapsing-remitting MS,
the most common form of MS. More than 340,000 patients have been
treated with TECFIDERA worldwide with over 625,000 patient-years of
experience, based on clinical trials and prescription data.2
TECFIDERA has been proven to reduce the rate of MS relapses, slow
the progression of disability and impact the number of MS brain
lesions, while demonstrating a favorable benefit-risk profile in
people with relapsing forms of MS, notably newly diagnosed and
early switch populations. In clinical trials, the most common
adverse events associated with TECFIDERA were flushing and
gastrointestinal (GI) events. Other side effects include a decrease
in mean lymphocyte counts during the first year of treatment, which
then plateaued, and liver function abnormalities, which resolved
upon treatment discontinuation. TECFIDERA is contraindicated in
patients with a known hypersensitivity to dimethyl fumarate or any
of the excipients of TECFIDERA. Rare cases of progressive
multifocal leukoencephalopathy (PML), a rare opportunistic viral
infection of the brain which has been associated with death or
severe disability, have been seen with TECFIDERA patients in the
setting of prolonged moderate to severe lymphopenia.
The efficacy and safety of TECFIDERA have been studied in a
large, global clinical program, which includes an ongoing long-term
extension study.
Please click here for Important Safety Information and full
Prescribing Information, including Patient Information for
TECFIDERA in the U.S., or visit your respective country’s product
website.
About TYSABRI® TYSABRI is a disease
modifying therapy (DMT) approved in more than 80 countries
including the U.S., the European Union, Canada, Australia and
Switzerland. In the U.S., TYSABRI is indicated as monotherapy for
the treatment of patients with relapsing forms of MS. In the
European Union, it is indicated as single DMT in adults with highly
active relapsing-remitting MS (RRMS) for patients with highly
active disease activity despite a full and adequate course of
treatment with at least one DMT or patients with rapidly evolving
severe RRMS. TYSABRI is proven effective, with over 10 years of
experience in treating RRMS, and more than 190,800 people treated
worldwide and over 658,169 patient-years of experience.3
TYSABRI is a monoclonal antibody that selectively binds to
α4-integrin and is thought to interrupt the activity of
inflammatory cells in MS patients by blocking the interaction
between α4β1-integrin and vascular cell adhesion molecule-1.
Disruption of these molecular interactions prevents transmigration
of leukocytes across the endothelium into inflamed parenchymal
tissue. The specific mechanism(s) by which TYSABRI exerts its
effects in MS have not been fully defined.
TYSABRI has advanced the treatment of MS patients with its
proven ability to slow the progression of disability, reduce
relapse rates and impact the number of MRI brain lesions with a
well-characterized safety profile. Data from the Phase 3 AFFIRM
trial, which were published in the New England Journal of
Medicine, showed that at two years, TYSABRI treatment led to a 68
percent relative reduction (p<0.001) in the annualized relapse
rate when compared with placebo and reduced the relative risk of
disability progression by 42 to 54 percent (12-24-week sustained
respectively, both p<0.001).
TYSABRI increases the risk of PML, a rare opportunistic viral
infection of the brain which has been associated with death or
severe disability. Risk factors that increase the risk of PML are
the presence of anti-JCV antibodies, prior immunosuppressant use
and longer TYSABRI treatment duration. Patients who have all three
risk factors have the highest risk of developing PML. TYSABRI
increases the risk of developing encephalitis and meningitis caused
by herpes simplex and varicella zoster viruses and clinically
significant liver injury has also been reported in the
post-marketing setting. Serious, life-threatening and sometimes
fatal cases have been reported in the post-marketing setting in MS
patients receiving TYSABRI. Other serious adverse events that have
occurred in TYSABRI-treated patients include hypersensitivity
reactions (e.g., anaphylaxis) and infections, including
opportunistic and other atypical infections. Clinically significant
liver injury has also been reported in the post-marketing
setting.
Please click here for Important Safety Information, including
Boxed Warning, and full Prescribing Information, including
Medication Guide for TYSABRI in the U.S., or visit your respective
country’s product website.
About Biogen At Biogen, our mission is clear:
we are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases. One of the
world’s first global biotechnology companies, Biogen was founded in
1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel
Prize winners Walter Gilbert and Phillip Sharp, and today has the
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first and only approved treatment for spinal
muscular atrophy and is focused on advancing neuroscience research
programs in Alzheimer’s disease and dementia, multiple sclerosis
and neuroimmunology, movement disorders, neuromuscular disorders,
pain, ophthalmology, neuropsychiatry and acute neurology. Biogen
also manufactures and commercializes biosimilars of advanced
biologics.
We routinely post information that may be important to investors
on our website at www.biogen.com. To learn more, please visit
www.biogen.com and follow us on social media – Twitter, LinkedIn,
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Biogen Safe Harbor This press release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, about clinical studies and real-world data
related to TECFIDERA, TYSABRI and the identification and treatment
of MS; the potential benefits, safety and efficacy of TECFIDERA and
TYSABRI; the identification and treatment of MS; the potential of
our commercial business, including TECFIDERA and TYSABRI; the
anticipated benefits and potential of our collaboration arrangement
with Siemens Healthineers; and risks and uncertainties associated
with drug development and commercialization. These statements may
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of similar meaning. Drug development and commercialization involve
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Results in early stage clinical trials may not be indicative of
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undue reliance on these statements or the scientific data
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These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation: unexpected concerns
that may arise from additional data, analysis or results obtained
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1 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: Sept. 25, 2018.
2 Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of 31 July 2018.
3 Global Natalizumab (TYSABRI) Postmarketing PML Update, August
2018.