June 21, 2010
In the name of the Medical Advisory Board of the German Multiple Sclerosis Society (Deutschen Multiple Sklerose Gesellschaft, DMSG), together with the neurological professional associations and in agreement with the Swiss and Austrian MS societies, Prof. Toyka and the board of directors have for the first time issued a recommendation on the use of the MS drug Natalizumab (Tysabri). The drug was withdrawn from the market in the US in 2005 and then reintroduced the following year. This was because patients contracted progressive multifocal leukoencephalopathy (PML), a serious and formerly often fatal virus infection of the central nervous system with severe neurological complications. The grounds for the recommendation were MS patients treated with Tysabri who then fell ill with PML. „All doctors treating MS patients with Natalizumab should have PML in mind if new neurological or psychiatric symptoms develop. Our specialists have worked out clear recommendations to ensure the safety of patients. First and foremost, every patient receiving treatment for a period of 24 months must once again be fully informed and monitored at very close intervals, should treatment be continued,“ says Prof. Toyka.
The German Multiple Sclerosis Society recommends magnetic resonance imaging as a first step in diagnosis. Should this not deliver definitive results, analysis of cerebrospinal fluid to ascertain the presence of the JC virus should be undertaken. Should this prove positive, the German Multiple Sclerosis Society and „Working group Immune Therapy“ initiated by Prof. Gold and other colleagues recommends plasmapheresis treatment „so that the active agent is eliminated from the body as quickly as possible.“
„Despite the serious and grave risks, we consider there are still no grounds to generally limit treatment with Tysabri strictly to two years,“ says Prof. Toyka. „The expert group led by Prof. Wiendl is also of this opinion.“
Source: Salute Domani
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1 comments:
Here in the US, if PML is suspected, not only are new MRIs recommended so that they can be compared to the MRIs taken prior to starting Tysabri therapy, Biogen is notified, and a sample of their CFS is immediately sent to Eugene Majors' lab at the NIH which is extremely sensitive to the JC virus because not all laboratories use the same test when evaluating a patient's CFS for the JC virus which can lead to the development of PML if activated in the patient's immune system.
A majority of the PML cases have been in Germany where they previously used Novantrone frequently to treat their MS patients--it is unclear what washout period they have been using prior to starting Tysabri, because they do not have the "Touch Program", nor is it clear whether or not the countries in the EU follow the same guidelines as the neurologists here in the US follow the FDA guidelines.
Lauren
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