Written: By Julie Stachowiak, Ph.D.,
Tysabri Discontinuation?
Monday August 23, 2010
Looks like people at Biogen Idec and Elan Corp., makers of Tysabri, have something to worry about. I usually don't follow the financials of the multiple sclerosis therapies too closely, but thought this one was pretty interesting.
An article in Dow Jones Newswires states "Deutsche Bank analyst Robyn Karnauskas recently projected that Tysabri's patient discontinuation rate, currently 2% to 3%, will skyrocket when oral therapies are available. She projects 20% of patients on the drug will stop using it in 2011 and 25% in 2012."
She predicts that US sales will decrease a full 40% by 2015 (from $633 million to $376 million), as new therapies come online. It is also not helping the situation that PML seems to be on the rise, with 5 new cases announced in the past week (see PML News That We Hate to Hear).
What about you? Are you on Tysabri? Are you planning to stay on it? Have you discontinued it? Why? Let us know your reasons in the comment section below.
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READ : http://ms.about.com/b/2010/08/23/tysabri-discontinuation.htm#comment-34696
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14 comments:
I am on Tysabri but I would be lying if I said that I would be on it forever. The oral treatments are really appealing to me and the risk of PML is really scary. I would have to wait and see what the new medications are all about though before I would switch over to them.
I have been taking TYSABRI over 2 years. I like only needing a treatment every 4 weeks + don't get any side effects.
But PML scares me!
The new oral drugs also have dangerous side effects. Cancer, for one. I've been on Tysabri for more than three years. I don't know what I'll do. I'd like to take the new test to see if I have the JC virus. The results would help me decide.
I have been on tysabri for 3 years now and so far, so good. No side effects except it has almost made me well again. PML is a concern but I am not too worried. If it happens It happens.I am looking foreward to the new oral pills.I drive 80 miles every 4 weeks for Tysabri.
i'm sticking to tyabri because the orals don't reduce the relapse rate as much.
Been on Tysabri now for 20 months - while it is not making me better - I haven't had any bad attacks while on it - so until my doctor says that something else is better, I'm sticking with Tysabri.
Been on Tysabri now for 20 months - while it is not making me better - I haven't had any bad attacks while on it - so until my doctor says that something else is better, I'm sticking with Tysabri.
Actually Cladribine looks like it is as effective, if not slightly more, in reducing relapse rate than Tysabri. HOWEVER, currently available information lists Tysabri as a drug that cannot be taken in conjunction with Cladribine due to increased risk of developing PML even no cases of PML have ever been reported with Cladribine use.
Cladribine will be taken daily for 5 days then twice during the next week then one more oral dose at weeks 48 and 52. That's 9 pills per year. I have no idea yet what the cost will be and if it will be covered by insurance as Tysabri is.
Cladribine has fewer side effects than Tysabri. Fingolimod, however, a daily oral likely to be approved first, has a greater incidence and severity of side effects than Tysabri, affects liver and kidney function and is a major risk if taken by persons living with herpes virus. Side effects rival the injectable interferons. There were 5 deaths in the trial of 1300 people. One from suicide, one from cancer (seemingly unrelated to the drug) one from a reactivated TB and two from herpes infections.
re: Cladribine and anything else not yet being used for MS.
Like Tysabri, during clinical trials there was no problem with PML and like many of these other meds in final studies or getting ready for approval, there too, not many problems to keep it from being launched.
It's not until thousands begin using the medications that problems are then discovered, that were not known to happen during the smaller trials...
There are risks to everything you use or do, in life. It's what risks you want to take to enjoy the life you have....
Regards,
Stuart Schlossman
I've been on Tysabri for 31 infusions and, in my case, it has dramatically improved the quality of my life. I can now walk when I could barely walk before I started. My balance has improved. Spasticity was improved. I'm leading a fuller life now. I worry about PML too but it really is about quality of life for me.
I don't know if I will switch to Cladribine but I doubt it. It is my understanding that Cladribine has a risk for PML also and it has a very long lasting effect on the body . My point is, if you should get PML while on Cladribine there is no way to quickly remove it from the body to improve your chances of fighting off PML.
There are risks with the pills too. Serious risks.
From the data I have seen on the current and projected data on the new oral medications for MS, most of them either have a multitude of side effects and/or do not have the efficacy percentage that Tysabri has, therefore I will probably stay with my Tysabri therapy.
I am having my 51st Tysabri infusion next week, and my neurologist takes a blood and urine sample once a year to test the strength or weakness of my immune system and to test my liver enzymes, both of which always come back normal, so I have absolutely no fear of developing PML.
Plus I get to see my neurologist every six months and a medical professional (my infusion nurse) every 28 days, and I seriously doubt that any MS patient will be able to receive that kind of care if they are on oral MS medications.
Considering that my Quality of Life has improved and remained stable (as well as my MS) for almost 4 years while on Tysabri therapy, I will be more than happy to remain on Tysabri indefinitely as it continues to keep me relapse free and has continued to slow my disease progression down.
Lauren
I will not change Tysabri unless my doctor recommends it. For the first time in 2 1/2 years I have my life back-that is better than anything that could come out. I'm not quitting.
I have been on Tysabri for over three years and I love it! My doctor, however, is worried about the PML risk and wants me on the first oral med to hit the market. I do not like what I am reading or hearing about the oral meds so I may ask about a drug holiday. That way I can go back on the Tysabri for 3 more years until the oral meds have been on the market for a while.
For Susan and others.
Get tested for the JC antibody and speak with your doctor about this...
If you test negative, it is known right now that you have a very low chance of PML.
If you test positive then the odds only increase in that it takes having JC antibodies in order to get PML ...
BUT, even if testing positive, this does not mean you are a definitive candidate for PML
THIS IS WHY YOU MUST SPEAK with Your doctor
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