Biogen Idec Inc., a Weston, Mass. Company, has reported another death as well, on top of the 9 more cases of progressive multifocal leukoencephalopathy (PML).
As of April 1st this year, the total of affected patients has moved up to 111 and the reported deaths are now 22. The last bump in PML caused only one of Lima’s four previous Tysabri users to quit undergoing the infusions and she is now trying Gilenya.
Her only thought with Gilenya is it’s lowering of the immune system and the worry it could bring with possible other infections, but knows this can be reversed within a few weeks if she quits taking it. That is a price far lower than PML, she believes.
The others still believe Tysabri is doing its job and look at how the reported PML rate is only at 1.31 per 1,000 patients and are thinking that is pretty good odds comparably.
A blood test is still in development phase with Biogen for the JC virus that is carried among 70 to 90 percent of the human population. It is believed to be able to cross the blood-brain barrier (BBB) and is found in both those affected with non-PML and PML brain tissue.
The problem possibly becomes consequential when biologic medicines such as Tysabri is used to temper our immune systems as it then activates the JC virus in some of the patients; which then leads to PML.
PML is almost nonexistent in patients who use Tysabri for less than a year, but incident rates have increased in those MS patients who have been undergoing the transfusions for longer:
1.99 cases per 1,000 for one to two years
2.50 cases per 1,000 for two to three years
Our FDA, Biogen and European regulators have, in the last few months, believed the Tysabri label should be changed to include language indicating the JC virus antibody is a PML risk factor, but no changes have been made apparent as of yet.
It’s only been recent that our labels have even included the possible PML so it could be awhile. Especially since only a few patients have even received infusions, about 36 and only about 66,000 world-wide, since the resumption in 2009.
Which is why the rate drops to 1.40 cases per 1,000 for more than three years.
Biogen has been active in studying patients and has warned there is “limited information from patients on the drug longer than 36 months” but recent data does suggest there is still good to be found in the drug.
Thousands will tell of the good it has done them such as with balance issues, “not having to hang onto the walls when walking”, says Lauren, and people like Henry who says, “I can finally ride Harley again”, and help with energy like with Mary who says, “I am gardening again, swimming again and enjoying summer like I haven’t in years.”
Tysabri has given thousands with MS a real chance to fight the progression that this disease has done on them and they have no intentions of giving it up.
For more info: for those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: 401 Tomahawk Drive, Maumee, OH at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Bing Maps.
Sources: www.brassandivory.org/2011/04/tyasbri-related-pml-deaths-holds-steady.html?amp& http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199872.htm
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