New Tysabri And Anti-JCV Antibody Stability Data Released - facebook prikbord

New Tysabri And Anti-JCV Antibody Stability Data Released
(18/03/13)Biogen Idec and Elan Corporation, plc announced results from several studies of Tysabri(R) (natalizumab) that demonstrate its efficacy compared to other multiple sclerosis (MS) treatments, provide additional data supporting anti-JC virus (JCV) antibody status stability, and suggest better outcomes when progressive multifocal leukoencephalopathy (PML) is detected early. These data will be presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego.

"These new data reinforce our belief in the substantial efficacy Tysabri has demonstrated at both the early and advanced stages of relapsing forms of MS," said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and chief medical officer, Biogen Idec. "We are also encouraged by the consistency in anti-JCV antibody status demonstrated over 18 months, as well as results from our pursuit of additional paths to help mitigate the impact of PML. These combined efforts may allow a more individualized approach when selecting Tysabri treatment, while helping physicians better understand a patient's benefit-risk profile."

Substantial Tysabri Efficacy Demonstrated Against First-Line Therapies

In an independent statistical analysis led by Timothy Spelman and Helmut Butzkueven, M.D. at the University of Melbourne, with contribution by Fabio Pellegrini and Annie Zhang, Tysabri demonstrated a significantly lower rate of first relapse compared to interferon beta (IFN) and glatiramer acetate (GA). This propensity-matched analysis was conducted using data from two MS patient registries: Tysabri Observational Program (TOP) and MSCOMET. The results indicate that relapses were not only more likely to occur in patients taking IFN and GA, but that they occurred more quickly, when compared to patients taking Tysabri (hazard ratio 2.73, 95 percent confidence interval 2.10-3.55, p<0.001). -- Comparison of Patients Treated with Natalizumab and Interferon-Beta/Glatiramer Using Propensity-Matched Multiple Sclerosis Registry Data (P01.211) will be available for viewing on Monday, March 18, 2013 from 2:00 to 6:30 p.m. PDT Anti-JCV Antibody Stability Data Support Risk Stratification Approach To help physicians better identify the most appropriate patients for Tysabri treatment, Biogen Idec developed a risk stratification approach. This approach assesses each patient's personal benefit-risk profile based on several factors, including anti-JCV antibody status, which was added to the Tysabri EU label in 2011 and the U.S. label in 2012.

An analysis of data from the longitudinal, observational U.S. study of Tysabri-treated patients, STRATIFY-1, demonstrates that anti-JCV antibody status remained consistent in 90 percent of the study population when tested every six months over an 18-month period. Approximately 38 percent of patients tested consistently negative and 52 percent tested consistently positive.

-- Longitudinal Stability of Anti-JC Virus Antibody Status in Multiple Sclerosis Patients: Results of STRATIFY-1 (S30.001) will be presented on Wednesday, March 20, 2013 from 2:00 to 3:45 p.m. PDT

Early PML Detection May Improve Survival

Results from Biogen Idec's ongoing research into PML, an infrequent but serious brain infection, suggest that TYSABRI-treated patients who develop PML and are asymptomatic at time of diagnosis may have improved survival and less functional disability compared with patients who are diagnosed when symptomatic.

This analysis includes preliminary data from four years of case reports and evaluates outcomes in 319 Tysabri-treated patients who developed PML, 21 of whom had no clinical symptoms of PML but were diagnosed based on magnetic resonance imaging (MRI) findings that were consistent with PML and spinal fluid that was positive for the presence of JCV. It shows that survival following PML was 100 percent in the patients without symptoms at diagnosis, compared to 77 percent in the patients with symptoms at diagnosis. Functional outcomes and disability were also better in the asymptomatic group one year after PML diagnosis: the average score on the Karnofsky Performance Scale, which measures functional outcomes, was 70 for asymptomatic patients (meaning the person can care for him/herself), compared to 47 for those with symptoms at diagnosis (meaning the person may be disabled and requires considerable assistance and frequent medical care; p=0.021); and scores on the Expanded Disability Status Scale, which measures disability, were numerically better for asymptomatic patients (3.7 vs. 6.5 p=0.066).

-- Natalizumab-associated Progressive Multifocal Leukoencephalopathy (PML) in Multiple Sclerosis Patients: Survival and Functional Outcome when Asymptomatic at Diagnosis (P04.271) will be available for viewing on Wednesday, March 20, 2013 from 7:30 a.m. - 12:00 p.m. PDT