ECTRIMS: un test de biologie pour détecter le virus JC.

Domyleen a écrit:[b]
A Göteborg, un poster a fait état ainsi d’une prévalence de 54 % de la positivité pour les anticorps anti-JCV dans plus de 800 échantillons de sérum provenant de patients SEP traités par natalizumab et soumis au test en ELISA.

MPascale a écrit:
"...demonstrating an overall prevalence of anti-JCV antibodies of approximately 50 to 60 percent and delineating the prevalence by factors such as age and gender...
Of the more than 800 patients evaluated, 54 percent tested positive for anti-JCV antibodies."

Dc pas très utile, si presque tt le monde a été infecté par JCV, et dc présente des Ac@JCV, on n'est que 1/1000 à faire une sep, et combien ss Tysabri ? Dt 50% ont déjà été infectés par JCV. Dc ça revient à proposer à la moitié de ceux qui st ss Tysabri d'arrêter.

Domyleen a écrit:(ms c'est une reprise du NASDAQ)
Biogen Idec Inc.'s diagnostic test that may help determine the risk of developing a rare brain infection in patients using multiple sclerosis drug Tysabri has received marketing approval in Europe.[/color]
Tysabri, sold with Elan Corp, is a highly effective treatment for the debilitating disease, but it has been linked in a small number of patients to progressive multifocal leukoencephalopathy, or PML. Global sales rose 16% to $ 1.2 billion last year, although growth has been lower than originally expected in recent years because of the risks of the infection.
There is hope that the development of a blood test may better determine the chances of patients contracting PML. The companies have applied to get the usefulness of the test put on the drug's label in Europe and the U.S., something that is separate from the approval of the test itself.
Although the overall risk of the infection remains small, it can have devastating and permanent effects, so the test may make patients and physicians more comfortable with using the drug.
As of Feb. 2, a total of 95 patients have been diagnosed with the infection and 20 have died. At the end of last year, 56,600 patients were using the drug.
PML is generally caused when the JC virus attacks the central nervous system in people with weakened immune systems, often leading to an irreversible decline in neurologic function and even death. The diagnostic test works by detecting antibodies against the JC virus in the blood with the intent of determining if a patient has been exposed to the virus, something that may increase the risk of PML.
In December, Biogen and Elan proposed updating the label of Tysabri to include information about the presence of the antibodies being a risk factor for PML. The company expects to hear from the agency in October and expects to have the test commercially available in the U.S. around the same time.
The companies also have filed to get the risk factor information in its European label, but the timeline is unclear. The approval of the test is separate from getting approval of the label change.
Biogen said the test is now available in Europe on a "limited basis" as it makes sure that its "process and procedures" are working correctly and it will be widely available by midyear.
The test will be available through a central lab and the companies will initially pay for the cost of sample collection and annual testing for patients.
"We are also taking a look at what other pathways are available for reimbursement," Biogen spokeswoman Kate Weiss said. She declined to name the operator of the lab.
As of early February, analysis of patient samples has found that in 22 patients who eventually developed PML and data is available, all were positive for the antibodies before diagnosis of the infection.
The companies are conducting two separate studies of the test, totaling 9,000 patients and spanning two years. The test is available to patients in the U.S. through those studies.