Dennis,

It's very encouraging to hear that you are doing well on Tysabri, especially so that you can be there for your son.  Perhaps it is much better for you that you have never been on any other MS meds and thus have not been exposed to other immunosuppressants.  I don't know that the neurologists know yet if a "Tysabri holiday" actually helps or makes much difference.

It seems very interesting (and smart) that in France patients do not get Tysabri until their CD4/CD8 levels are checks to make sure that their immune systems are normal before they begin.  It's also interesting that this topic is discussed as much on investment message boards as it is on MS message boards.

Your neurologist sounds like she was presenting all the options to you, but obviously she must feel comfortable with keeping you on Tysabri.  She wanted to make sure that you are also comfortable with staying on it.  Lauren Roberts (a highly vocal Tysabri patient advocate in California) reports that she just had her 40th infusion today.

Probably the most important thing is to carefully watch for any unusual changes in your symptoms which might be caused by PML which is tough since they overlap with possible MS symptoms too.  To be honest, I would talk to your neurologist about any concerns you may have.  She knows your case and you know your body.  She also should have access to more information than we do (I would hope).

BTW, I hope that your body is getting over this cold very quickly.  :)   I woke up feeling better today, still coughing like crazy, but better.

Hi again Lisa, 

Thanks for the answer!

I don't know if they checked my CD4/CD8 levels before I got started on Tysabri, they did take a lot of blood-samples and a new spinal-fluid extraction some weeks before and they told me that they had to wait for the results before they could give me Tysabri. 

I've had the same doctor during all of this, and I trust her. She also "went out on a limb" when giving me the opportunity to get Tysabri as first treatment for MS in my case, and after asking me, I'm also one of her case-studies because of this. 

The Tysabri news you added as a reply as well, gives more input that helps me in my thoughts, deciding if I should use Tysabri or not. I've not had one relapse of MS since started, and if I stop using it, nobody could know if I might get bad quickly, or not.

I think I'll continue using it as I told my doctor, and perhaps, during next summer holiday, I'll try without. But as the article you added said, more than half of the patients getting PML, had been on some other kind of immunosuppressive therapies, so perhaps my "vacation" would consist of not using any medication at all against MS during that time. 

Aah, and the cold, yes, already yesterday I started feeling better. Still have a lot of couging and sneezing, but I think I'll live, again :-) 

Take care and thanks for the answers and thoughts !

With kind regards 

// D

P.S. Here is the Tysabri news as the National MS Society put it together today.

Oct 29, 2009

Update on Tysabri and PML: Company Releases Details of Cases and Risks

According to information released yesterday 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 Tysabri’s 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 person’s 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.

The FDA provides post-marketing safety warnings on Tysabri at this link, although the updated information above is not currently provided.

So, my neurologist suggested that I start on Tysabri for a year and then go to an oral MS medicine after that.  there are two that he's investigating and they are getting positive results.  the reason that he suggested Tysabri was because I have new lesions and he wants to be sure I'm heallthy and well for the long term.  He doesn't want me in a disabled state.  I have tried Rebix.  they said my liver count was on the high side.  they put me on Copaxone and that's been fine.  Physically I feel fine!  no issues there.  the MRIs are what's concerning to my neurologist. 

I understand the issue of Tysabri and he was pretty firm that being on it for a year will be safe.

thoughts?

thanks,

REO

REO,

It's good to hear that you feel good physically!! Whatever path you choose for treatment, I hope that it is effective in keeping you from disability for many years to come.