"Our mission is to translate science from the lab to the clinic to the market."
Press Release
 |
| 28 April 2009 |
| MRI Data Showing TYSABRI® Promoted Remyelination Presented at the 61st Annual Meeting of the American Academy of Neurology |
“What we have seen in these MRI data suggest that TYSABRI may have the
capacity to repair and possibly restore some of the damaged myelin
sheath that protects nerve fibers. Results from this study support the
continued investigation of the potential effects of TYSABRI on this
process,” said Robert Zivadinov, M.D., of the
“TYSABRI is changing the way neurologists and patients define success in
the treatment of MS,” said
”Everyday, more patients understand that TYSABRI can represent a new way
of looking at – and managing – their disease,” stated TYSABRI helped stabilize and restore damage to the myelin sheath The imaging study, which included a total of 110 subjects, used an advanced MRI technology called the Voxel-Wise MTR to measure lesions and normal brain tissue. The study showed that TYSABRI promoted remyelination when compared to those receiving interferon beta-1a IM and normal controls. The effect of TYSABRI on lesions and NABT in relapsing MS was evaluated with a Voxel-Wise (VW) imaging method using magnetization transfer ratio (MTR). VWMTR is recognized as a powerful instrument for monitoring MS disease activity and effectiveness of therapeutic interventions in patients with MS. In the study, 62 MS patients who received TYSABRI were followed for 12 months together with 26 MS patients who received interferon beta-1a IM and 22 age-matched and sex-matched normal controls. For each subject, baseline and follow-up MTR volume maps were placed in a common halfway-space. The resulting VW subtraction map was then enhanced via threshold-free cluster enhancement (TFCE) algorithm, and a significance threshold was determined based on subject-specific Monte Carlo simulation. Supra-threshold volumes (95th percentile) were quantified for both areas of increasing (remyelinating) and decreasing (demyelinating) MTR voxels, which represent a volume value. There was no significant difference in decreasing VWMTR NABT volume over the follow-up between TYSABRI-treated and normal control groups. Relapsing-remitting patients on both therapies showed higher remyelination potential and less evident demyelination than relapsing secondary progressive patients. The volume of VWMTR changes in NABT (decreasing or increasing) was almost 3-5 times higher than the amount of changes observed for T2-lesion volume. This indicates that the VWMTR method might be a much more sensitive approach to capture demyelination/remyelination changes over time than the lesion-based volume measures.
The poster describing the study Natalizumab (Tysabri®)
Promotes Remyelination in Patients with Multiple Sclerosis. A Voxel-Wise
Magnetization Transfer Imaging Case-Control Study (P03.071) is
available for viewing on TYSABRI significantly increased the cumulative probability of achieving sustained improvement in disability in patients with relapsing MS
The poster describing the study Sustained Improvement in Physical
Disability with Natalizumab in Patients with Relapsing Multiple
Sclerosis (P06.131) will be available for viewing on
Data from this post-hoc analysis was previously presented at the 2008
Patient-Reported Outcomes Study In this study, patients with relapsing-remitting MS were asked after three months of treatment to rate their improvement, using validated outcomes tools. The posters presented at AAN show that overall, patients reported significant improvement in cognitive function, general and disease-specific health-related quality of life, and lower-levels of fatigue after the third infusion of TYSABRI. The ongoing one-year longitudinal study assesses health outcomes from the perspective of the patient before starting TYSABRI and at predetermined timepoints thereafter.
One of the posters, Early Effects of Natalizumab on Patient Reported
Fatigue and Cognitive Function (P02.142) was made available for
viewing on About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the U.S.
and relapsing-remitting MS in the In early 2008, TYSABRI was approved in the U.S. to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. According to the US full prescribing information, among patients who responded to TYSABRI, 54 percent sustain their response through every visit for one year compared to 20 percent of patients receiving placebo (p<0.001), for a treatment difference of 34 percent. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI as monotherapy. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. TYSABRI is approved in more than 40 countries. For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255.
About
About Elan
Source:
MEDIA CONTACTS: |
 |
 RSS Feeds |  E-mail Alerts |  Contact IR |