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Copyright 2005 Science Letter via NewsRx.com & NewsRx.net
Science Letter
August 16, 2005
Two-year study of Tysabri with Avenox reinforces efficacy in multiple
sclerosis
Biogen Idec (BIIB) and Elan Corporation, plc (ELN) announced that Sentinel,
the phase 3 Tysabri (natalizumab) add-on trial with Avenox (interferon
beta-1a), achieved the 2-year primary endpoint of slowing the progression of
disability in patients with relapsing forms of multiple sclerosis (MS).
The addition of Tysabri to Avenox resulted in a 24% reduction in the risk of
disability progression compared to the effect provided by Avenox alone. Data
from Sentinel also demonstrated that the addition of Tysabri to Avenox led
to a 56% relative reduction in the rate of clinical relapses compared to
that provided by Avenox alone. The reduction in relapse rate was
statistically significant and sustained over the entire 2-year study period.
Other efficacy data from Sentinel at 2 years, including MRI measures and
immunogenicity, were similar to previously reported 1-year results.
Common adverse events included headache, nasopharyngitis, limb pain,
depression, flu-like symptoms, diarrhea, insomnia, sinusitis, influenza,
nausea, muscle pain, anxiety and cough. The rate of infection was 1.6 per
patient-year in both Avenox plus Tysabri-treated patients and Avenox plus
placebo-treated patients. Serious infections occurred in 2.9% of Avenox plus
placebo-treated patients and 2.7% of Avenox plus Tysabri-treated patients.
Tysabri has been associated with hypersensitivity reactions, including
serious systemic reactions which occurred at an incidence of less than 1% of
patients.
On February 28, 2005, Biogen Idec and Elan announced that they voluntarily
suspended Tysabri from the U.S. market and all ongoing clinical trials based
on reports of progressive multifocal leukoencephalopathy (PML), a rare and
potentially fatal, demyelinating disease of the central nervous system. The
companies have previously reported 3 confirmed cases of PML, 2 of which were
fatal. 2 of the patients with confirmed PML had received Avenox plus Tysabri
for over 2 years as part of the Sentinel trial. Biogen Idec and Elan's
comprehensive safety evaluation concerning Tysabri and any possible link to
PML is ongoing. The results of this safety evaluation will be discussed with
regulatory agencies to determine the appropriate path forward for Tysabri.
Sentinel is a 2-year, randomized, multi-center, placebo-controlled,
double-blind study of 1,171 Avenox-treated patients in 123 clinical trial
sites worldwide. In the trial, Avenox-treated patients who continued to
experience disease activity were randomized to add Tysabri (n=589) or
placebo (n=582) to their standard regimen.
The companies anticipate that 2-year data from Sentinel will be presented at
the 21st Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS).
Biogen Idec and Elan are collaborating equally on the development of Tysabri
in MS, Crohn disease, and rheumatoid arthritis.
Biogen Idec creates therapies in the areas of oncology, neurology and
immunology. Elan Corporation, plc is a neuroscience-based biotechnology
company.
This article was prepared by Science Letter editors from staff and other
reports. Copyright 2005, Science Letter via NewsRx.com.
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