Hi guys

You may have alread had this posted, but since I have found out that I am JC Positive, I am on the lookout for information and alternatives:

"April 13, 2012 — A case of progressive multifocal leukoencephalopathy (PML) has been reported in a patient with multiple sclerosis (MS) taking fingolimod (Gilenya, Novartis).

Novartis AG confirmed that the company has been informed of a PML diagnosis in a patient on fingolimod, but points out that the patient was treated with natalizumab (Tysabri, Biogen Idec/Elan) for approximately 3 ˝ years before being started on fingolimod. The patient is also JC virus (JCV) antibody–positive, a company statement notes.

Natalizumab treatment is associated with a known risk for PML, particularly in JCV antibody–positive patients and those treated longer than 2 years.

"The current assessment is that Tysabri is the drug most likely associated with this case of PML," the company notes in their statement. "However, a contribution of Gilenya to the evolution of this case cannot be excluded."

"This is the first and only reported PML case in approximately 36,000 fingolimod-treated patients," the statement adds. "Novartis believes Gilenya provides a benefit for appropriate MS patients when used in accordance with approved labelling."

http://www.medscape.com/viewarticle/762039

Since this is so new, it could be the start of something , or just a result of Tysabri use, since the person had been on Ty for 3.5 years.

Who knows, but short of taking nothing , or going back to Beta (or similar) I don't see many choices.

Lyn

Oh Lyn.....so scary!

There are risks and benefits to EVERY drug. Aspirin included. Some effects are what we seek when we take a drug, like caffeine keeps you awake, dilates blood vessels and speeds up your heart. We want to wake up! but we dont always want our hearts to race. Some times that side effect is infection, organ failure, or even death.

I am so glad that you are really researching whether or not you want to continue on Ty, even tho the risk is 1 in 10.6 of developing this dread disease, and they are working hard to figure out how to pull patients out of it if they get it. You are making an INFORMED choice and I couldnt be more proud of you.

Keep up the good work.

You mean 1 in 1000, don't you.

Last research I saw was in in every 10.6 test positive for the virus and run a sizeable risk of infection.

Do you have a link to that research? Thanks.

Yes Dej - you should be proud of me

Here is some info I have found - the quotes are not necessarily direct, I got it all from this source, but only included relevant stuff that jumped off the page at me. If you follow the link, you may have to fish around a bit through links etc to find all the info I have used:

Most patients were treated with rapid removal of natalizumab from the circulation using plasma exchange or immunoadsorption. Nearly all of the patients (91%) developed immune reconstitution inflammatory syndrome (IRIS) and were treated with corticosteroids.

IRIS presented as new or worsening neurologic symptoms, tended to be severe, and usually occurred within days or weeks after rapid removal of natalizumab, the investigators note. "By 6 months post diagnosis, most of these patients had either recovered from IRIS or had started to recover from IRIS," Dr. Richman added.

Of the survivors followed up for at least 6 months from the time of PML diagnosis, one-third had mild disability, one-third had moderate disability, and one-third had severe disability, based on physician-reported Karnofsky scores. However, the investigators urge caution in interpreting the residual disability data, which were "probably confounded by disability attributable to underlying MS."

201 cases of PML have been reported among approximately 96,582 patients treated with Tysabri worldwide through January 4, 2012. The survival rate is now at around 71 %.

However, among those patients who have survived with at least 6 months of follow-up, most (87%) rate moderate to severe on the Karnofsky Performance Status Scale.

In addition, although the data show an 80% survival rate, this comes at a price, he said. "This is a miserable disease. If you got it, you'd probably rather be dead because there's no treatment for it — it destroys brain tissue. Eighty percent to 90% of people are highly disabled if they survive PML."

Anti-JCV Antibody Positive*
Tysabri Exposure 1-24 months <1/1,000
Tysabri Exposure 25-48 months 4/1,000

http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm#hcp

I misspoke, and Im sorry. the research I saw said it was 10.6 per 1000 cases, but I was unable to find the paper I saw.

I did however see some documents that say if you have had prior suppression therapy your risk is 11 in 1000 as you reach your 24th treatment. if you have never had therapy to suppress before your risk is 4 in 1000 as you reach your 24th therapy. They are seeing the longer you are on it, the higher the risk, but most occcur between 24 and 36 months of treatment. you MUST be positive for the JC virus to develop PML.

Click on link then look for RISK factors with PML on the right side tab. Scroll down to blue chart.
http://www.tysabri.com/pml-risk.xml#test-results

Too many numbers

Just breaks my heart.