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 That released the latest analysis of natalizumab (Tysabri,) risk stratification

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Join date : 2012-03-30

That released the latest analysis of natalizumab (Tysabri,) risk stratification Empty
PostSubject: That released the latest analysis of natalizumab (Tysabri,) risk stratification   That released the latest analysis of natalizumab (Tysabri,) risk stratification Icon_minitimeMon Jun 11, 2012 5:57 am

Today, one hundred Kin Eddie (NASDAQ: BIIB) and Elan Public Company Limited (NYSE: ELN) announced that: in the HMTase New England Journal of Medicine published in patients with multiple sclerosis, of TYSABRI (he natalizumab) and the occurrence of progressive multifocal leukoencephalopathy (progressive multifocal leukoencephalopathy, abbreviated as: PML) the risk of global risk management program results. PML is a rare but serious infection of the brain, often the patient death or serious disability. The HNMT project investigated the three risk factors associated with PML: anti-JC virus (JCV was a first discovery of PML polyomavirus, named after the first letter comes from the discoverer) antibody status of TYSABRI therapy before the use of immunosuppressive agents, and long-term use of TYSABRI treatment.100 Kin Eddie and Elan to develop quantitative risk stratification algorithm to help HNRNPC physicians and multiple sclerosis (multiple sclerosis, abbreviated as MS) patients when considering TYSABRI therapy treatment can be more confident. TYSABRI is an effective treatment for relapsing forms of MS.Of Alfred Sandrock, MD, Ph.D., Biogen Idec, senior vice president, development and chief health officials, said: "through the identification of these risk factors, and their inclusion in the HOMER1 risk stratification algorithm, we make the treatment of MS with a personalized treatment the advantages of this treatment is designed to help patients better understand their own benefit and risk in considering the use of TYSABRI therapy. "The researchers use data from clinical studies, after the listing information and the Swedish independent record data to assess the HP incidence of TYSABRI-treated patients with PML. As of February 29, 2012 data collection stops, from 99,571 in TYSABRI-treated patients identified 212 patients with PML. These data used to develop risk stratification algorithms based on the three PML risk factors. These three risk factors were: anti-the JCB antibody status, use of immunosuppressive therapy before the treatment of TYSABRI treatment of the length of time (divided into 1-24 and 25-48 months two groups). Based on the presence or absence of these risk factors, patients were divided into different subgroups, each subgroup the occurrence of PML risk.

From to participate in phase III trials - AFFIRM, STRATIFY-1 and the TYSABRI Global Observational study by the Project Safety the (TYGRIS) part of America - a total of 5896 blood samples of MS patients and multiple sclerosis registries in Sweden, including MS patients The blood samples were anti-JCV antibody detection.In addition, according to the data records of the 54 PML in TYSABRI-treated patients, and blood samples were collected 6-187 diagnosed with PML before anti-JCV antibody test results, all test samples are anti-JCV antibodies.Some participants TYSABRI-treated patients do not have data on the use of immunosuppressive therapy before the treatment. Therefore, the use the global TYGRIS (United States and other regions of the world) in immunosuppressant use proportion, it is estimated that the use of immunosuppressive therapy in the treatment before the proportion of TYSABRI-treated population.PML risk increased with the extension of TYSABRI treatment time, and 2 years after treatment, the risk of the fastest growing. More than four years of treatment data is very limited.The use of immunosuppressive therapy, the proportion of pre-treatment in the emergence of PML in patients with higher than the accepted TYGRIS study of all patients (34.5% for the former and the latter 20.3%), indicating that the use of immunosuppressive agents in the treatment of the risk of PML associated with an increased54.9% of the prevalence of anti-JCV antibodies in the general MS patients (95% confidence interval 53.7% to 56.2%); and the development of PML in patients, the prevalence of 100% - this state is called before the PML anti-JCV antibody status. 54 MS patients all PML anti-JCV antibody status, under the premise, assuming that the anti-JCV antibody-negative patients on PML, the use of sensitivity analysis estimated the risk of PML occurred in patients with antibody-negative.

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