Pink, I have to beg to have blood work done When I first began my Ty infusions they were drawing blood every month. Now they will go for 6-8 months without drawing blood. So, I have asked my primary care physician to do it for me every 3 months. I know it can be painful, Pink. And, some infusions centers will draw the blood after they have inserted the I.V. needle but before they begin the infusion.....so you're only pricked once. It's important to check your CBC and liver regularly when you are on Ty. I'm considering asking my PCP to do it monthly or at least every 2 months for me. BTW, Pink, I'm terrified of needles and they have me labeled as a "hard stick".

Good luck, Pink. I know how painful it can be.

hugs,
Shayna

Hi Pink,

Sorry you have to go through pain for this. The infusion center can do a blood draw when they do your IV. They already stuck you and they can take a few seconds to do the draw before they run the IV. Ask your doc if he can get the sample when the infusion center does the stick. That way you only have to endure one stick.

My doc still runs all the tests once every 6 months, but I have regular contact with him outside of appointments and he is always looking for signs and symptoms of something wrong when he sees me. He's very observant and there are times when I feel like a bug because I know he is doing a survey while we are chatting!

Good Luck!

Thanks for all of your help. Much calmer here! What scared me so much is the nurse said she I had to have a great vein, as she was taking blood. After your help, it seems it is all the same (as long as I get the blood then infusion). I would think they would have to have a so-called great vein for the infusion too. I've had a few bad final sticks, but make it through the TY and then they flushed the saline. I will make sure I have the sample taken when they do the stick.

Hey Pink?

Have you tried lidocaine before they do the stick? My infusion center uses it and it makes the stick much less painful for me. I never used to use it and one of the nurses asked if I wanted it. I tried it and found the stick to be a lot easier.
I would take the stick without it to get the Ty anyway, but it does hurt less when they have to go fishing.

No Riverwild, I was not aware such a drug existed. I've researched it and it looks great. Thanks so for letting me know about it. I will request it at my next; I hope they have it. If not, it sure looks like one they need to stock. As always, you make life easier. Thank you for all the time and energy you have spent researching this disease and always being here to share your knowledge.

Every infusion center has it in stock. They should have offered it when they saw that you were in pain!

It's a liquid that needs to be injected under the skin. It isn't supposed to sting at all but sometimes it does for me, but only a little and it goes away immediately. It forms a little bump when they inject it that disappears as it is absorbed into the tissues and they inject it right next to where they are doing the stick. The nurse may rub it a little to spread it into the tissues faster. As soon as it is injected it starts to work, so they can do the stick immediately. It's injected with a very tiny needle right under the skin.

It also comes in gel form and in patches for different uses, but for infusion, they use the liquid.

Good Luck and please let us know how it works for you!

Excerpt from a Citigroup analyst report on Biogen. Anyone heard boo from their Neuro when we might be tested?

"STRATIFY-1 Trial Needed to Confirm STRATA Retrospective Analyses

The STRATIFY-1 trial is enrolling 1,000 new or existing patients. The trial is conducting both urine and serum testing every year for a period of 2 years. The test is essentially being used to confirm the retrospective findings of the STRATA study. Recall that retrospective analysis of this study led to confirmation that the JCV antibody assay can detect patients that have been exposed to the virus with a false negative rate of only 2.5%. The trial is collecting urine samples to determine the false negative rate of the assay in a prospective setting. This is because patients who shed viral DNA in the urine are considered to have been exposed to JCV. Thus, the analysis of blood with the JCV assay should be able to confirm that these patients are positive for the virus.

STRATIFY-2 Testing How JCV Can Determine Risk of PML Development

The STRATIFY-2 trial is testing the assay in patients who are currently on Tysabri or who are new to the drug and is expected to enroll ~8,000-25,000 patients. There is no fixed length of time for STRATIFY-2 and only serum samples are being collected every year for a minimum period of 2 years. The purpose of STRATIFY-2 is to determine what is the PML risk in patients who test negative in the JCV antibody test. Neither STRATIFY-1 nor STRATIFY-2 are being mandated as part of the TOUCH program. There is nothing in the protocol of these studies about treatment decisions if the patient is positive or negative for JCV antibodies. The powering of the study is difficult to determine, because it depends on how many patient get tested and how many patients get PML. Data disclosure remains to be determined. Biogen Idec intends to share the data with regulatory agencies in order to
eventually get language into the label in regards to the risk of PML in patients who are positive or negative for JCV antibodies.

Enrollment in STRATIFY-1/2

The pace of enrollment in STRATIFY-1 & 2 is dictated by site activation. Currently more than 250 patients have already enrolled in STRATIFY-1 and enrollment is also going well in STRATIFY-2. The test is expected to be
eventually available in 100% of the centers enrolled in the TOUCH program. There are many registries ex-U.S. interested in the PML assay, but STRATIFY-1 & 2 are being conducted exclusively in the U.S.


Commercial Availability of the PML Assay

There is a path in mind to commercialize the PML assay. However, the lab company has not gone public with its plans thus far. The availability of the assay will also differ between regions because of different requirements among them. There is a lower hurdle to get the test approved as a JCV antibody assay compared to a validated assay that can help determine the risk of PML. The price of the assay, when it becomes commercially available, has not yet been determined. However, this test is fairly standard and is routinely reimbursed by payers. "

My doc said he did the paperwork. I will get an update next time I see him in mid may.

No, but I heard the paperwork is in from mine too. I'll see the nurse in June (she acts as a PA). I'll know then. I think River will prob know first.

Excerpted from a biotech newsletter:

Tysabri (natalizumab) is a breakthrough. Never before was a drug developed that made it difficult for the immune system cells to mobilize and stage an autoimmune attack. The hypothesis was validated time and time again with the confirmed unparalleled efficacy of Tysabri. Data from the market and from testing continue to demonstrate the drug’s superior efficacy in containing most MS symptoms. In the AAN meeting Elan and
Biogen Idec presented study results demonstrating that Tysabri sustains visual function, diminishes disability, boosts overall quality of life (QoL), cognition and fatigue in multiple sclerosis (MS) patients. Tysabri is described as changing the way neurologists and patients define success in the treatment of MS.

Here are some of the drug’s findings as presented in the AAN meeting :

- Sustaining visual function and improving vision;
- Sustaining physical function and mental improvement;
- Improving psychological wellbeing;
- Reducing fatigue; and improving cognitive function.

Loss of vision and difficulty walking are among the most concerning symptoms associated with MS. Psychological disturbances are also devastating to patients and families.

The PML Problem and the PML expected test
Here we have good news that we hope will end the fear campaigns against Tysabri.

Perpetrating frightening news for personal gain hurts the firm’s stock price, the companies, their employees, the great science, and more important, the patients who believe all they read on the Internet. Such rumors have caused patients who badly need the drug to refuse to take it. At the AAN meeting, Elan and Biogen Idec announced that they have evidence that patients who developed progressive multifocal leukoencephalopathy (PML) had antibodies to JC virus that causes PML prior to using Tysabri. The patients’ blood, which was collected long before they received Tysabri, tested positive for the virus. In light of these findings, scientists are now optimistic that a test that pinpoints those vulnerable to developing PML is possible.

I have changed some of the wording to make the points more clear. I do not have a link yet since it is a pay site and it takes a few days for it to be public but this is the gist of the newsletter's take on Tysabri and the assay for PML. I will post a link as soon as one becomes available.