6th Tysabri Patient Diagnosed with PML

Julie,

If you’re going to post this type of information please do a little research. The methods for treating PML in a Tysabri patient is the same as it was back in Aug 08 – Plasma exchange to remove Tysabri from the bloodstream, methloquin, and agressive management of immune reconstitution inflamatory syndrome. 5 of the 6 PML patients are alive and Biogen has commented that the 1 patient who died was not treated properly. So it looks like the treatment standard has been proven.

As for the critique on when the case was reported, Biogen provides an update of confirmed cases every Friday as a standard procedure. Their reporting followed this procedure. Please let us know what other drug companies provide weekly updates on adverse events included in their drug labels.

Chris

Forgot to add that 5 of the 6 PML cases have now occurred outside the US. It looks like 4 of the 6 cases have occurred in Germany alone.
I’d be nice to know if usage in Germany differs from elsewhere in the world possibly conferring different levels of PML risk in Germany and in the rest of the world.

Chris,

Thank you for clarifying that the treatment you outlined for PML is now pretty much standard of care in Tysabri-induced PML – I was not aware that it was that accepted already. I do know that there is a clinical trial underway testing the mefloquine that you mention (an anti-malaria drug) in 40 patients with PML from any cause, whether drug-related or from HIV.

About the timing of the report – I agree with you that a weekly update of adverse events is a testament to Biogen’s commitment to keep people informed (although it is interesting to note that the information is NOT posted under patient information or any news tabs, but is contained in an unlabled PDF file under “Investor Relations.”) However, what was called into question in other media reports was the fact that the shareholders’ meeting occurred between the time Biogen had the news of the 6th case and the Friday report.

I always tell people. I’m not afraid of the PML. I’m afraid of another relapse.
So far I had 63 infusions of Tysabri and I feel great. Thanks to Tysabri I have my life back. (:
In the US we have the TOUCH program but they don’t have the TOUCH program in Europe.

I think it is a travesty that Biogen must report weekly the cases of PML that are possibly linked to Tysabri. So far, each of these patients have had very low immune systems due to prior medications that they were on such as Azathioprine/Imuran, Methotrexate, or Novantrone, with one of the patients being treatment naïve (although MS experts believe that he must have been treated regularly with steroids to control his aggressive form of MS). Is Biogen weekly reporting the cases of PML due to Rituxan?-No Was Genentech weekly reporting cases of PML due to Raptiva?-No Is Roche weekly reporting cases of PML due to CellCept?-No Is Sandoz weekly reporting cases of PML due to Azathioprine?-No Is Abbott Laboratories reporting weekly cases of PML due to Methotrexate?-No…, etc.

This weekly reporting by Biogen is ludicrous.

Lauren (MS patient for 33+ years and current Tysabri patient for more than two years)

Julie,

If you ever have any question before future Tysabri blogs please shoot me an e-mail and I’ll try to answer. I follow the situation closely as I’m on the drug (2 years, 4 months) and like to be well informed as there is a lot of poor information out there (what do you expect from the financial press!).

Chris

I am on Tysabri, and every time I hear this, I make sure I blast it out to everyone listening, WHERE the case of PML cropped up.
Biogen posts the information on it’s website. Since it was reintroduced in the US in 2006, only ONE patient contracted PML here in the states. It was like breaking down FORT KNOX to get on this drug, which means that there are systems in place here to protect us. And Tysabri has GIVEN ME MY LIFE BACK. If the media would tell the truth about this drug, more MS patients could be on it, and they could feel normal. I don’t wake up every day now thinking “I have MS.”
http://investor.biogenidec.com/phoenix.zhtml?c=148682&p=irol-TPME

Bartira & Erin….both of you say Tysabri has given you “your lives back”….would be interested to know what was going on before (symptoms) and what is happening now that has given your lives back…truly would like to know.

I agree with Brady, curious to know how Tysabri has helped you. Could you share with us if your MS lesions are in your brain or spinal cord or both? And your symptoms before & after Tysabri.

I was diagnosed in March 2001 and eight years ago I had two very bad relapses. I had all the symptoms in the MS book;
I lost my balance, stiff legs, I was dragging my left leg, no coordination, blur and double vision, tingling, numbness and the worst of all… I had cognitive problems. I was getting lost in conversations, scanning for words, switching words and letters.
I was confused between reality and a dream. It was a nightmare.
Thanks to Tysabri I have my life back.
My EDSS is 0 and I have 0 symptoms.
I had my last MRI in January and it looks great. So, I’m happy again!!! (:
Bartira

wow….horrible symptoms….when did you begin the Tysabri?…and has your use been continuous?….also, what when was your first MRI and what did it show?…and how did your last MRI in January compare to your first one?

http://finance.yahoo.com/news/MRI-Data-Showing-TYSABRIreg-bw-15062358.html?.v=1

New today on Tysabri……..

I have been on Tysabri since December of last year. Since I started the infusions I cannot tell that I am any better, if anything I am worse. I’ve had two major relapses since I started, my first one I lost most of my vision driving home from work and my last one was in March and I have not been able to bounce back from that. I still drag my left leg, get sick very easily with all different kinds of infections(because of my immune system being so weak),fatigued, keep headaches all the time and it drains the life out of me when I get my infusions. I did not respond well to my other treatments prior to starting Tysabri, so I kind of feel like this is my last option. Can somebody tell me what the symptoms are for PML? Thanks, Rosita

Brady and Linda Jean,
I was diagnosed in April 2008. Third MS attack (first two were mild and went away quickly). Third attack started off with tingling in the back, numbness on the left side of my body, and before I knew it, I couldn’t hold anything with my left hand and had absolutely no feeling on the left side of my body. My vision got a little worse (got a new script for contact lenses), when I moved my neck, I’d get an electrical shock down my whole body. I was severely fatigued, my balance was off, my memory went down the tubes, and my muscles were twitching/jumping in my legs. I started Avonex in May 2008 and did a total of 13 solumedrol treatments. The combo therapy definitely helped improve things. I have almost all of the feeling back in my left hand. However, I was fatigued, was still getting the muscle twitching, my memory was terrible, and I felt like I was walking around in a huge fog. Even though the attack was over, the symptoms were still pretty active. My MRI in early 2008 showed a large lesion (inflamed) in my spine. It also showed two in my brain (one being large and inflamed). My neuro suggested me going on Tysabri. Detoxed from Avonex and steroids in December 2008 and had my first Tysabri infusion in January 2009. I’m 31, work full time, and I’m type A personality. Four Tysabri infusions and the ONLY side effect is feeling very TIRED after the infusion. That lasts not even 24 hours. If you’ve been on any of the injectibles, you know that they have flu like symptoms. I had the flu once a week from Avonex (not knocking it though). With Tysabri, I have NO side effects. My fatigue is gone, my balance is better, my muscles will still twitch, but it’s not a constant. I’m not walking around in a fog. I feel that my quality of life has improved greatly. I really feel like I have my life back. For me, the biggest thing is that I’m no longer exhausted and can do the things I did before I got diagnosed. I also ecstatic that my cognitive issues have pretty much gone away. I know someone else on Tysabri who was using a cane. He doesn’t use a cane anymore.
One VERY important note—-just had an MRI. No new lesions. The two largest that were inflamed are SMALLER and aren’t inflamed anymore. And if you’ve read articles that have come out over the past few days, the news about Tysabri is amazing. The biggest issue is: I don’t think the rest of the world has caught on to protocols. And we have to remember that Tysabri is not the only drug with PML as a possible side effect. I believe the doctors and the drug company and the FDA have really put a strong system in place to protect us.

I agreed with you Erin.
I testify at the FDA when they re-approve Tysabri and YES, the FDA and Biogen Idec worked very hard to get the TOUCH program in place and I believe they did a great job.
I understand that everyone has a different experience with Tysabri. My experience with Tysabri is great. No side effect. I feel safe with Tysabri. I have my life back. I’m having a second chance of life.(:
My MRI has no new lesions. It only shows two very old, small “dots” (lesions)
Bartira.

Hi Rosita.
I advise you to talk to your doctor about the PML symptoms…
You also can go to the “msactivesource.com” for answers.
MS Active Sources it’s a great site.
Bartira

Erin’s blog. (:

http://erinandms.blogspot.com/

oH my God! I am shocked by what I’m reading! Happy, relieved and scared all at once. I was diagnosed in Sept. 2000- but it should have been 10 years earlier. I’ve had bouble vision, optic nueritic(2), transverse mylitis, problems walking, arm weakness, fatigue, you all know the game. My 14 year thinks I’m still playing a good game. I am a 35 year old wife and mother of two. I recently seeing saw a new doctoctor who wants to change my thearapy to tyabri. Our firt response was no becouse of fear. The PML scared me more than the MS. But I am so sick of living with the dissabilties,pain depression, constant attacks and hopelessness. This morning I woke up wanting to go for it. Finding this web site confirmied my decision to do it. I’m not going to be afraid. Thank you all for the information!!

Good for you Sheryl!!!(:
Feel free to send me an email
bartira_ms@comcast.net

I have been on Tysabri for 1 year, and so far no side effects. Initially, I did not detect any real benefit, but after about 5-6 months I felt better. This could be for any number of reasons (water therapy, taking a class etc.) I have been on three other therapies and PML does not scare me as much as having a relapse that would make my life miserable.

I am glad to hear some Tysabri users saying it has given you “your life back”. But I feel compelled to report that I got my life back 5 years ago (from secondary progressive MS) from an inexpensive oral medication that has zero risk: Low Dose Naltrexone.

MS patients desrve to know this is an option, before having to choose medications that have death as a side effect.

I am so glad I found this site with all your comments! I have been on Avonex continually since 1998. I don’t know how to recognize a flare up, as I seem to have symptoms all the time. I was diagnosed with RA when I was 15. I’ve had arthritis symptoms all my life, although they cleared up while on Avonex, and I no longer carry the RA factor in my blood. Could that have been MS then? No one knows. After all, that was the ’70s…….
My symptoms are, however, getting more pronounced. Hence, my Dr. has suggested Tysabri. I was hesitant since she is heavily connected with Biogen. (Was she looking out for my wellbeing, or does she get an incentive for how many patients she has on the drug? Can’t help it; I’m a Chicagoan!)

I have an appointment this afternoon to discuss things with my dr. I have been off Avonex for 6 weeks now. I don’t miss the injections. After reading all your blogs, I am now happy to say yes to Tysabri. My only7 concern is that I am prone to infection. I want to have my life back. I am a 53 year old mother of 3. And I probably had MS back in the ’80s, but I was referred to a neurosurgeon who liked to cut, and I ended up with back surgery (T6 and T7). That only increased the banding in my diaphragm. (I REFUSE to call it an MS hug, as hugs are pleasant, and this is NOT)

I work part time at a public library; I’d like to be able to ride a 2-wheel bike again!
But I will be exposed to a host of germs in that environment. I’d hate to quit, as having a job has kept me off of antidepressants. I am on disability, so I’m working for my metal and emotional health.

Thank you to all of you for giving me this excellent “fodder” to digest! –Sandi V.

I lost my wife to PML in December of 2008. She was using TYSABRI for the treatment of her MS. I cry each day because I want her back. My life will never be the same. I worry now about the new cases of PML. I wish all of you good luck in your MS treatments. If you have questions please ask.

Hi. I am 42 and had multiple sclerosis since I was 18 but did not get diagnosed until I was 32. I started Tysabri treatment back in August of 2008. I stopped treatment that same year in November because I saw no improvement. My doctor called that a medicine holiday. But four months after stopping I had a massive exacerbation. Premium hospital for almost a month. The MRI at the time showed almost 40 lesions both in my brain and my spinal cord. Once released from the hospital I started back on my Tysabri treatment. I’ve been on for nine months and just add a new MRI. All clean from active lesions but I have not gained back any of my mobility or physical control of my hands and feet. Unfortunately I’ve had it so long that the nerves in my feet and legs are not wanting to work again. There is no sensation either minor or major where I can feel pain from my knees down. I still feel Tysabri has done wonders for me. I now realize just because I can’t see the effects of Tysabri doesn’t mean that it is not working. I’m grateful every day for the chance to live a somewhat normal life. This disease is the worst it gets people like us with a most depressing feeling no control. Whether it has effected us for a short time or for many years I have the most unbelievable compassion for all of us. My Dr. will only allow me to be on Tysabri four year and then I must stop. According to him there is a new drug being tested but the side effects are not known yet. So since none of the other drugs have ever worked for me it will be a waiting game until something comes out. It’s nice to read your comments because nothing makes you feel more lonely than that of the feeling that no one understands you. I am anxious to read your comments and you know that there’s someone else out there that feels and goes to the same thing I do. Kevin

My mom has MS and has had it for about 20 years now I’m guessing. She is on her 27th infusion of Tysabri. At first it seemed like she was doing great. She said she could actually walk around the grocery store when before she could only use a power scooter. But it’s different now. I didn’t see her for 7 months, of course I talked to her all the time, but now I’m seeing a different person. Still the same person in my eyes, but it seems as if her brain has almost reverted to that of a child. Her memory has gotten exponentially worse, and her ability to say a word that she wants to say has also. It’s now very hard to carry on daily conversation with her. She also cannot walk as well. Today I called her, and she answered the phone and said she was mad at my brother, put me on hold for another call and never came back. I eventually hung up the phone, waited for her call but it never came. I called her back about half an hour later, and she said, “hi hows it going?”, and she didn’t even remember talking to me. Then i asked her about my brother and why she was so mad and she said, “what are you talking about? why would i be mad at your brother?” This has NEVER been this bad. Why is this happening? Is this just MS taking it’s course? Or is this early symptoms of PML? What is going on?? Someone please answer.. I’ve been away from her for almost a year now and her MS has gotten exponentially worse, and I really fear that she may be taking something thats causing this..

lol u got owned by tysabri