Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Patient-reported outcomes study shows improvements in quality of life among patients after 1 year of treatment with TYSABRI

16.04.2010
Data also showed reduced fatigue and improved cognition

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced results from a one-year, longitudinal health outcomes study (n=324) in which patients with multiple sclerosis (MS) who received 12 infusions of TYSABRI (natalizumab) reported improvements in quality of life (QoL) measures, as well as reduced fatigue and overall improved cognitive function, as measured by validated tools.

The goal of the study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, was to assess patient experiences with TYSABRI in a real-world setting. This research was presented in three posters at the American Academy of Neurology's (AAN) 62nd Annual Meeting in Toronto, April 10 - 17, 2010. The AAN Annual Meeting is the world's largest gathering of neurologists.

"Because MS is such a debilitating disease that affects patients physically, cognitively, psychologically and socially, it can have a significant impact on their quality of life," said William Stuart, M.D., Medical Director of the Multiple Sclerosis Center of Atlanta. "These analyses, based on patient-reported outcomes, are critical to understanding the benefits of treatment with TYSABRI over the long term and in a real-world setting."

The one-year longitudinal study assessed health outcomes from the perspective of the patient using validated patient-reported outcome (PRO) measures prior to treatment initiation and after the third, sixth and 12th infusion with TYSABRI in a real-world setting. A majority of the patients in the study were female (77.8%) with mean age of 46.7 years and mean years since diagnosis of nine years.

Quality of Life Study Results

After one year of treatment, patients reported statistically significant improvement in:

general health-related QoL, as measured by the 12-item Short Form Scale (SF-12v2), with higher scores indicating better QoL

MS-specific QoL, as measured by the 29-item Multiple Sclerosis Impact Scale (MSIS-29), with lower scores indicating better QoL

Both scales report the physical and psychological aspects of QoL in two summary scores. For both scales changes in mean scores from baseline through the 12th infusion were evaluated after adjusting for baseline patient-level and treatment characteristics.

SF-12v2 Physical Component Summary (PCS) scores improved significantly from baseline (BL 34.25, 12th 36.66; p
After controlling for covariates, a statistically significant improvement was also observed in MSIS-29 physical impact scores (BL 47.38, 12th 40.43; p

The results of these findings are consistent with results from pivotal clinical trials and show the beneficial impact of TYSABRI on QoL in MS patients. Results show that improvements were seen as early as three months and were sustained for 12 months.

The poster titled Improvement in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab in the United States (P02.166) was made available for viewing on April 13 from 3-7:30 p.m. EDT. The poster titled Effect of Natalizumab on Disease-Specific Quality of Life after One Year of Natalizumab Treatment (P02.164) was made available for viewing on April 13 from 3-7:30 p.m. EDT.

Fatigue and Cognition Study Results

After one year of treatment, patients reported:

improvement in cognitive function
lower impact of fatigue on daily functioning
Cognitive function was measured by the six-question Medical Outcomes Study Cognitive Functioning Scale (MOS-Cog Scale, score range 6-36) with higher scores indicating better reasoning skills, memory, concentration, ability to start several actions at one time and ability to react. Fatigue was measured by the five-question Modified Fatigue Impact Scale-5 (MFIS-5, score range 0-20), with lower scores indicating lower impact of fatigue on physical, cognitive and psychosocial functioning.
After controlling for covariates, on average MOS-Cog scores increased significantly over time (BL 25.12; 12th infusion score 26.19, p=0.0006), indicating improvement in cognitive function, and MFIS-5 scores decreased significantly (BL 12.36; 12th infusion score 11.16, p

The poster titled Improvement in Patient-Reported Fatigue and Cognitive Function over Time with Natalizumab Treatment (P06.167) was made available for viewing on April 15 from 3-7:30 p.m. EDT.

Dr. Stuart serves as a paid consultant for Biogen Idec.

About TYSABRI

TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.

Data from the Phase III AFFIRM trial highlights TYSABRI's powerful efficacy. According to that data, which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. 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 been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Corporation, plc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

Kate Weiss | EurekAlert!
Further information:
http://www.tysabri.com
http://www.biogenidec.com
http://www.elan.com

More articles from Studies and Analyses:

nachricht Real-time feedback helps save energy and water
08.02.2017 | Otto-Friedrich-Universität Bamberg

nachricht The Great Unknown: Risk-Taking Behavior in Adolescents
19.01.2017 | Max-Planck-Institut für Bildungsforschung

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

Switched-on DNA

20.02.2017 | Materials Sciences

Second cause of hidden hearing loss identified

20.02.2017 | Health and Medicine

Prospect for more effective treatment of nerve pain

20.02.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>