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Press Release
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| 11 September 2009 |
| Data Supporting Unique Efficacy of TYSABRI Presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis |
-- TYSABRI redefines expectations of multiple sclerosis therapy for some patients --
"MS patients should expect more from an MS therapy and studies such as
these demonstrate the potential for TYSABRI to satisfy their
expectations," said
“The strong efficacy profile demonstrated in clinical trials is enhanced
further from these and other important TYSABRI data presented at
ECTRIMS," said TYSABRI significantly improves physical and cognitive function This post-hoc analysis from the Phase III AFFIRM trial was conducted using the MSFC, a measure of disability that assesses aspects of neurologic dysfunction in MS not captured by Expanded Disability Status Scale (EDSS), to evaluate the effects of TYSABRI on disability improvement in patients with baseline impairment. Baseline impairment was defined when a patient experienced at least one of the following:
The MSFC was administered to patients every 12 weeks; change from baseline to two years was a prespecified secondary endpoint. In the study, 460 patients received TYSABRI and 225 received placebo. Results showed that TYSABRI significantly increased the proportion of patients who improved from baseline to two years on the T25FW (p=.023), 9-HPT (p=.001) and PASAT-3 (p=.012) compared with placebo. The effect of TYSABRI remained significant for the T25FW, 9-HPT and PASAT-3 compared with placebo when improvement was defined as an improved change from baseline sustained for at least six, seven, or eight out of ten planned study visits.
“This data showing the ability of TYSABRI to improve both physical and
cognitive function represents a new paradigm for defining success in MS
therapies,” said Natalizumab improves disability on the Multiple Sclerosis Functional Composite in a randomized, double-blind, placebo-controlled study of patients with relapsing multiple sclerosis (poster P434). TYSABRI stabilizes and restores damage to the myelin sheath Results from the study showed TYSABRI promoted regeneration and stabilization of damage done to the myelin sheath, as measured Voxel-Wise MTR (VWMTR), an advanced MRI technology, when compared with those receiving interferon beta-1a IM and healthy subjects. In the study, 77 MS patients who received TYSABRI were followed for 12 months along with 21 MS patients who received interferon beta-1a IM and 17 age-matched and sex-matched healthy volunteers. TYSABRI significantly promoted remyelination when compared to patients treated with interferon beta-1a IM and healthy volunteers. There was no significant difference in decreasing VWMTR NABT volume over the follow-up between TYSABRI-treated patients and healthy volunteers. Relapsing-remitting patients on both therapies showed higher remyelination potential and less evident demyelination than relapsing secondary progressive MS patients. Evolution of Voxel-Wise magnetization transfer ratio in natalizumab and interferon beta-1a IM treated patients with multiple sclerosis. A case-control study (poster P721). TYSABRI patients report improvement in physical and psychological well-being This ongoing, one-year longitudinal observational study assesses health outcomes from patients’ perspectives before the start of TYSABRI treatment and after the third, sixth and 12th infusions. The Multiple Sclerosis Impact Scale-29 (MSIS-29) will be used to assess the impact of TYSABRI on disease-specific quality of life. Over a six-month period, the study showed patients receiving TYSABRI experienced a consistent improvement in both their physical and psychological well-being, suggesting that TYSABRI may improve overall quality of life of MS patients over time. What do multiple sclerosis patients experience? Effect of natalizumab on disease-specific quality of life over time (poster P872). About TYSABRI
TYSABRI is approved in more than 40 countries. In the U.S., it is
approved for relapsing forms of MS and in the TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. 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
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