Update on Tysabri and PML: Company Releases Details of Cases and Risks
According to information released on October 29, 2009 by Biogen Idec, there have been 24 confirmed cases of progressive multifocal leukoencephalopathy (PML, a viral infection of the brain that usually leads to death or severe disability) among people who have used Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) after it became available for prescription in July 2006.
As of the end of September 2009, 60,700 people have used Tysabri worldwide. Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the sponsor has now released data suggesting that the risk increases with increasing time on therapy, starting out lower than the one-in-one thousand level that was estimated at the time of Tysabris re-approval in 2006, and rising after two years of infusions to about one in one thousand.
There is insufficient information to determine the risk of PML in those who have been on therapy for three years or more. Right now only 2,000 people have been on the therapy for over three years.
This release followed an October 23 announcement from the EMEA, the European equivalent of the U.S. FDA, indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri in light of the increasing number of new cases of PML.
Signs of PML:
Typical symptoms associated with PML progress quickly over days to weeks, and can include:
• personality or behavioral changes
• changes in thinking, memory, and orientation leading to confusion
• onset of seizures, clumsiness or progressive weakness on one side of the body
• disturbances of vision
If individuals taking Tysabri experience new, unusual symptoms, they should contact their prescribing physician immediately. Physicians who need guidelines on the protocol to follow when they have a patient on Tysabri who experiences unusual symptoms should contact Biogen Idec.
Details of Cases: According to the company, the 24 cases of PML have occurred in both men and women who had been given infusions of Tysabri every four weeks for a duration ranging from one year to three and a half years, with an average of two years.
·16 of the cases occurred in Europe, and 8 in the United States
·4 of the 24 died
·The degree of disability in the 20 survivors is a wide spectrum: at the milder end, some have recovered enough to return to work, and at the other extreme, some are confined to bed, requiring extensive assistance with activities of daily living, and others were in between this range. Further details of their condition were not provided.
·It appears that when PML is detected and treated early, it generally improves outcomes. It is important that individuals taking this drug and their doctors be vigilant in monitoring for any occurrence of new, unusual symptoms that might indicate PML.
·Based on these cases, the sponsor stressed that, contrary to prior information, the presence of gadolinium-enhancing lesions on MRI does not exclude the possibility of PML. Likewise, the absence of JC virus DNA in the spinal fluid does not exclude PML.
·There has been no characteristic among those who have developed PML that would give substantial clues to who might be more likely to develop it, except that half of the cases had prior histories of having been on immunosuppresive therapies, such as mitoxantrone, and less commonly, azathioprine and methotrexate.
·Right now there is no test that can predict who is more likely at risk for developing PML while using Tysabri; in a large company-sponsored study, testing of blood cells, plasma, serum and urine for the causative JC virus in people before and after 48 weeks of Tysabri therapy (Rudick et al, ECTRIMS 2009) did not show any differences in the presence of the virus in those fluids. The results of these studies, performed at the U.S. National Instituties of Health, differ somewhat from an earlier study (N. Engl. J. Med. 361:1067, 2009) suggesting higher virus levels after treatment.
·When PML was suspected, Tysabri infusions were halted. There is no specific therapy to treat PML, but the best hope is to reconstitute a persons immune responses. In most of the 24 cases, once PML was confirmed, Tysabri was removed from their systems with the blood-cleansing treatments of either plasma exchange or immunoadsorption.
During the aftermath of PML, as the immune system begins to recover, a condition called IRIS (immune reconstitution inflammatory syndrome) usually occurs about 4 weeks after the removal of Tysabri from the system. The sponsors suggested that some of the treating physicians found that prompt use of intravenous steroids to treat this brain inflammation led to improvement.
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Living with PML - 10-24-10by angelusa738,040 views
After nearly three years with Tysabri I was tested positive on this JC-virus.
Now I'll get Fingolimod...
But the question was and still is: Will the risks stay?
Sumpfhexchen 4 weeks ago 2
@Sumpfhexchen I wasn't tasted for the PML virus because it wasn't offered to me at the time and I was also told that it wasn't a sure test because it was new and that it could have changed at any time...well, they were all wrong and they played withj my life and almost caused me to die, but I made new videos where I showed that I was stronger that the virus and that I won the battle, not an easy task to do and I hope that, if you can avoid taking this aweful drug. good luck to you,
Angela
angelusa73 4 weeks ago
@Sumpfhexchen I think that, for as long as people stay on the derug and continue to take it, the risk will be there but once you stop, the risk should go away.
Just remember you that, unfortunately, PML can be awonken by AIDS, cancer and it' aeful medications and other immune suppressent medicines or the by many other various disesases. I think that, if you stop taking Tysabri, the risk of you ever getting thePML will definately be even more rare and should be almost impossible. best of luck
angelusa73 3 weeks ago
@angelusa73 Thank you, no one gave me an answer except of you...
Keep on fighting!!!! WIsh you only the best!!!
Sumpfhexchen 3 weeks ago
@Sumpfhexchen I am glad I was able to help a little, even if I am not a doctor which I think it's better because I ca use my heart and not be clinical and cold like a fish... :) thank you for the wishes that I share with you, because I hope that only good things will come your way, now and forever. Thank you for writing and have a wonderful day,
warm hugs,
Angela
angelusa73 3 weeks ago
Hi, I've just been diagnosed with MS & have had 2 relapses in as many months. The first relapse I had, the doctor thought it was labrynthitis as I had been really dizzy & sick.
The second time, I couldn't lift my left leg & my hands had the tingling sensation, so the doctor referred me to the neurologist.
A week later, I had a MRI scan & lumbar puncture which confirmed that I had MS as I had alot of lesions, and they think it's something I've had for quite a while.
Looking back, last Novembe
OneManTagTeam 1 year ago
@OneManTagTeam Dear new friend,
finding out of having MS is never easy and you have been throught quite a lot. I saw the video of your wonderful wedding and of your beautiful love story and I know you will be strong and you will fight this! A year has gone by since you found out about your MS and now there is more hope in the MS world thanks to doctors that are trying to help us find a cure for it! I wish you and your loved one the very best! You will always be in my prayers!
Hugs
Angela
angelusa73 1 year ago