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news.Results from Biogen Idec and Elan Corporation's phase III trial evaluating Tysabri as a monotherapy in multiple sclerosis, have shown the drug to have a significant impact on both disability progression and relapse rate.
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The two-year Tsyabri (natalizumab) AFFIRM monotherapy trial achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of multiple sclerosis (MS).
Tsyabri treatment led to a 42% reduction in the risk of disability progression, relative to placebo, and demonstrated a 67% reduction in the rate of clinical relapses over two years, which was sustained and consistent with one-year results.
Other data from AFFIRM at two years, including MRI measures and immunogenicity, were similar to previously reported results.
The adverse event profile at two years was also consistent with previously reported results. The incidence of infections in Tsyabri-treated and placebo-treated patients was similar and hypersensitivity reactions, including serious systemic reactions, occurred in less than 1% of patients.
“Results from the two-year monotherapy clinical trial mark a major milestone in the treatment of MS. These two-year data strengthen our belief that Tsyabri will become the leading therapy for MS patients,” said Dr Lars Ekman, executive vice president and president of R&D at Elan.
The companies anticipate that two-year data from the AFFIRM trial will be presented at the American Academy of Neurology (AAN) meeting in April 2005, while two-year results from the SENTINEL add-on trial with Biogen’s Avonex are expected to be available mid-year. Two-year data from both studies will also be submitted to regulatory authorities.