MS-Tysabri- Brain Disease- a New Test

Tysabri Can Cause PML a Brain Infection

health.msn.com
health.msn.com

I am both surprised and shocked by the press release surrounding the latest disease modifying drug (DMD) TYSABRI. I am surprised that Biogen, the drug’s manufacturer, is hoping to provide a test capable of alerting a Tysabri user to the potential risk of developing a brain infection as a result of taking the drug. I am shocked,(in a good way) because if the test proves effective, it will make Tysabri a drug I can consider using once every 4 weeks instead of Copaxone, which I now self-inject daily. That is, if the test assures me I don't have to worry about subjecting myself to PML.

The screening tool could be marketed as early as 2011 if clinical trials involving 9,000 people, set to start this year, show a low rate of false findings.

Presently, everyone who agrees to be given Tysabri in the form of a IV, has the slight risk of getting the JC virus that causes progressive multifocal leukoencephalopathy, or PML, a brain-cell destroyer that can lead to disability and death. Some people with MS have died from this infection others have had to recover from the infection which can be more crippling then the MS it is suppose to modify.

If a potential user takes the guess work out of the process by being screened ahead of time, there would be more people with MS who could take the drug and significantly reduce worrying about contracting PML. Of course, if the screening shows you are likely to develop PML, you simply forgo TYSABRI all together.

The company has reported 42 PMLcases. Tysabri was removed from the market on Feb. 28, 2005, after three patients developed PML, and two died. It has since been approved again and is mostly recommended now only after other drugs fail, or if reactions to the other drugs make sustained use unlikely.

Interestingly 61 percent of 285 neurologists surveyed by RBC Capital Markets in San Francisco said Tysabri’s ability to slow MS progression would make it their first choice if they could assess the risk of PML.

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From my own personal experience, my neurologist has had only positive results with Tysabri. No patients have developed PML or had to be taken off the drug. The last time we spoke about it, he had full confidence in its ability to treat MS effectively.

cbc.ca
cbc.ca
vernbeachy.com
vernbeachy.com

Tysabri in a Nutshell

As pictured, Tysabri is administered via an IV solution, much like solu-medrol steroids. After the IV is administered and the patient has waited the required amount of time to insure no adverse reactions the patient is free to leave the facility until the next scheduled IV dosage is given.

Because of the dangers, Tysabri users are closely monitored and tested. Close adherence to the guidelines are a must for any MS patient who agrees to begin using Tysabri.

“PML occurs when a common germ, called JC virus, mutates, then evades the body’s immune defenses and penetrates the brain, causing irreversible damage. Researchers theorize that Tysabri may subdue defenses meant to keep the virus out of the brain.”

 

“The test is designed to detect the presence of an antibody to the JC virus in the blood of patients, signaling that the patient has been infected.

With a false-negative rate of 2 percent, patients who are free of the virus would lower their risk of getting the brain disorder PML to 1 in 25,000 for the first three years of their Tysabri therapy”

 

What makes TYSABRI different?

  1. TYSABRI works in a different way.TYSABRI is an antibody, not an interferon (AVONEX®(interferon beta-1a), Betaseron®(interferon beta-1b), Rebif® (interferon beta-1a)) or glatiramer acetate(Copaxone®)
    • TYSABRI is thought to inhibit white blood cells from getting into the brain and attacking nerves
    • Keeping these cells from attacking nerves is believed to result in fewer brain lesions that cause multiple sclerosis symptoms
    • The way in which TYSABRI works has been studied, but the exact way that TYSABRI works is not fully known
  2. TYSABRI is taken differently than other multiple sclerosis medicines. With TYSABRI:
    • You can avoid the hassles of self-injection
    • You only have to think about taking your MS treatment once every 4 weeks

You can find more detailed information about TYSABRI by clicking on the link to the website, below.

It's the Not Knowing that Can Kill

Imagine how you would feel if you decided to try Tysabri, only to end up being the one out of a thousand that actually ends up developing PML. Best described as a brain infection, PML, if serious enough, can cripple both mind and body.

Currently doctors have become more skilled at picking up the infection and treating it more swiftly. However weighing the pros and cons still puts Tysabri on the short end of the stick. Understandably, many-MS patients and neurologists alike-are just not willing to take the risk, so Tysabri goes unprescribed and under-utilized.

However, if the manufacturers are able to come up with a reliable test that accurately tells me I am not likely to get PML, I will be happy to trade in my daily injections for a once-a-month IV infusion.

Oral medication (a pill) is also still in the pipeline, so between the two, I am hoping to be off the daily injection ride within the next year or two.

I will be monitoring the PML screening Biogen plans to put in place and I hope it turns out to be something that truly works.

Vern Beachy Infusion #42 March 2010

Not to Say There Are Not Success Stories

What has the outcome been for those who have accepted the risks involved and have been using Tysabri for weeks or years?

It is always encouraging to read or listen to a successful outcome. So, to present a well-rounded view of the drug, I have included a Youtube Video of "Vern" who talks about his 42nd infusion. His opinion is very important to those who have tried all other drugs and are now down to just a couple of alternatives.

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29 comments

FlourishAnyway profile image

FlourishAnyway 3 years ago from USA

When Tysabri first came out my neurologist was pushing it hard, but I resisted. I read all of the fine print and was scare about jumping from the frying pan into the fire. For those who do well on it, I am so happy. Generally, I prefer to be late to the party with new drugs. Thanks for this informative hub. All the best to you and other MSers. Keep up the good fight.


Jen's Solitude profile image

Jen's Solitude 4 years ago from Delaware Author

Your welcome Cheryl, let me know what you find out when you have the time.


Cheryl keith 4 years ago

Thank you Jenn. I will check Facebook for advise from other Tysabri users. I appreciate the advise.

Cheryl


Jen's Solitude profile image

Jen's Solitude 4 years ago from Delaware Author

Hello Cheryl Keith, I have never read of such a thing happening to anyone on Tysabri! It is truly shocking and so potentially dangerous. Since I don't have any helpful suggestions I would like to suggest that you go on Facebook and relate your experience to the community of Tysabri users and ask their advice. I am taking Gilenya, the new oral pill and so far have not crossed paths with any problems. Maybe you can look into one of the other disease modifying drugs?


Cheryl Keith 4 years ago

I have been taking Tysabri since 2002? I travel to Vancouver every 28 days from Vancouver island. I have relapsing remitting MS. Other than a one year hiatus from the drug, due to concerns of PML I have not taken a break. I have been told I am one of the longest case studies? Last week when I went for treatment they told me I had tested positive for the JC virus. Thought it was strange as I have not had a blood test in at least six months. I asked them to look back to make sure this diagnosis of the JC virus was recent. Guess what? It wasn't!! They have known I was positive for the virus since Dec 2010 and didn't tell me till now. Feb 2012?? Losing faith in this company and doctors. Have stopped treatment. I am 40 yrs old and a professional show jumper! Any advice?


Jen's Solitude profile image

Jen's Solitude 5 years ago from Delaware Author

MAC, so happy to read you tested negative for the JV virus. I hope you have continued success! Thanks for your comment.


MAC 5 years ago

I was tested last week for the JC virus. My blood had to be sent to copenhagan. I am on infusion 24 and PML was always at the back of my mind, but as I an negative now I don't need to worry and can continue on. The next test they are going to do is check my body's antibodies are not reacting to the Tysabri as that can make it less efficient so fingers crossed for that one too. Wishing everyone all the best with whatever treatment they are on


Jen's Solitude profile image

Jen's Solitude 5 years ago from Delaware Author

Wishing you all the best as you begin Tysabri, mil. Hope your problems are few. :)


mil 5 years ago

I am going to start tysabri next week and I'm getting really nervous but reading some of the comments and watching the video eased some of my fears...thank you


Jen's Solitude profile image

Jen's Solitude 5 years ago from Delaware Author

It's a pleasure to meet you AllboysMom! We share the same killer symptom fatigue. Prozac is keeping me from being too tired to get out of bed, and I'm happy to take what I can get. Thanks for dropping by.


AllboysMom profile image

AllboysMom 5 years ago

I was diagnosed with MS in 2000 and my younger brother was diagnosed in 1996. He is considering Tysabri and did have the blood test to see if he is at risk for developing PML. I've been injecting rebif for five years and am maintaining. Fatigue is the most debilitating of my symptoms, and the most frustrating. I hope someday we have a cure for this disease. Great article, thanks for posting!


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

You are most welcome my friend. I think about you when I read about this drug.

No doubt a neurologist has to prescribe it since they have to make sure you understand the risks, and they have to set up the infusions and have you sign the release. It is all well regulated and the neuros must follow the instructions to the letter.

I hope you have a neuro close by who can prescribe it for you.


Rascal Russ Miles profile image

Rascal Russ Miles 6 years ago from Show Low, AZ USA

Thank You so much for such an informative Hub. My PCP said that he couldn't prescribe it but I may still find a local doc that can...


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

A waiver is mandatory travel_man. I am a long way from considering this. First they would have to come up with a test, then I would have to be cleared by the test and then there would have to be no other alternatives for me to consider. Just thought it would be interesting for those already at this stage in there disease progression. Good hearing from you!


travel_man1971 profile image

travel_man1971 6 years ago from Bicol, Philippines

Are you going to sign a waiver before undergoing DMD treatment as in TYSABRI? Drug manufacturers are the one's benefiting for this, right? Anyways, thanks, for this hub, Jen. It keeps me updated, too.


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

Hi Vern, thanks so much for sharing your positive experience with Tysabri. I am so glad it is helping you, I am envious of your walking ability! ;-) Thank you also for giving me permission to use your video, I am sure it will be greatly appreciated by those searching for good experiences concerning Tysabri.


Vern Beachy 6 years ago

Hi Jen;

Your hub is well done and informative. I know the risks of PML but, for me, it is minimal because of the tremendous positive effects I have had since I began taking Tysabri more nearly three years ago.

I was using a wheelchair and crutches for many years and now I walk 2 miles a day. I couldn't imagine walking 20 steps (without help) before Tysabri. I itch (slightly) during the infusion but that is the only negative side effect I have had. The positives far outweigh any risk of PML (for me).


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

Thank you Kath, I place your opinion in high regard and am glad you feel the Tysabri info was even handed. :-)


Kath Ibbetson 6 years ago

Hi Jen

I love your very informative posts and may I compliment you on your ability to keep an even handed approach to your subjects.

Many thanks

Kath


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

Kind of you to read and comment Ladyjane! :-)


ladyjane1 profile image

ladyjane1 6 years ago from Texas

Thanks for sharing this information it was very well done.


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

Yes, with every passing year it seems something new is in the pipeline and not just for relapsing/remitting MS. Thanks for your encouragement, fishtiger.


fishtiger58 profile image

fishtiger58 6 years ago from Momence, Illinois

Hopefully soon Jen they will have the answers you need to make your decisions. Have a great day my friend.


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

I have a friend who recently began Tysabri and she has never felt better! Your friend might really want to look into this, GarnetBird, hopefully the results will be the same for her.


GarnetBird profile image

GarnetBird 6 years ago from Northern California

Wow; my best friend has MS and many lesions; I will tell you about this. Great Hub, Jen!


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

Thanks for your interest in all things MS, BK!


BkCreative profile image

BkCreative 6 years ago from Brooklyn, New York City

I could only find out all this information by following you here on hubpages.

Great hub!


Jen's Solitude profile image

Jen's Solitude 6 years ago from Delaware Author

Thanks Aaron, Tysabri might not be as well known as the drugs but it is helping roughly 400,000 worldwide.


AARON99 6 years ago

A very informative hub on this desease. I didn't know about it till i read your hub. Thanks for giving such a valuable informations. Well done. Enjoy.

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