Nov 232004
 

Well the much anticipated drug has gotten FDA approval. This will certainly give me something to talk to the neuro about in February. I’m sure we’ll stick with my current Rebif therapy until Tysabri has a year or so on the market – or I start to get worse again. Plus I need time to convince the insurance company to cover both drugs. My one question if why the heck did they change the name to one that I can’t even begin to figure out how to pronounce! Here is the press release from Elan: FDA Grants Accelerated Approval of TYSABRI. Of course Serono had previously already raised some issues with the release of Antegren/Tysabri: Promising Antegren data ruffles Serono. I agree that two years worth of data isn’t much to go on but it was enough to get Rebif approved. I’m definitely of the mind set of wait and see both on efficacy and on safety – I’m not in the market to be a guinea pig. I am amused that this is produced by mice and Rebif is produced by hamster ovaries – will all the treatments come from the rodent family?!?

 Posted by at 9:22 pm

  17 Responses to “Antegren (or the new name Tysabri)”

  1. Check out http://www.tysabri.com/, you can download the product information, looks REALLY good…

  2. Hmmm, I have an itching for some cheese….

  3. Eric you bring up ggod points. The name Tysabri (tie-SAB-ree) which means strentgh and protection was chosen instead of Antegren because there is another infusable product that is to close the sound of Antegren, that is Integrelin (used for ACS). You can wait to use Tysabri, however you will be missing out on the 66% reductions in relapses and the shutdown of the disease. Look at the one year MRI data-its great. Just to so you are at ease-the safety data on Tysabri is a median of 20 months and the efficacy data is 13 months. I have spoken to at least 30 MS patients who will all be taking Tysabri. They are feed-up with injection site reactions, side effects, and only getting a 30% reduction in relapses. Over 200 patients in the Tysabri studies. Serono is bad mouthing data because they are scared. Also for the Avonex users when Tysabri was added there was an additional 54% reduction in relapses. The time is now to speak to your Neuro and get on Tysabri. The disability data should be out in the spring. The true question is why did the FDA approve Rebif. All Rebif showed was they had a greater effect on relapse free days through 24 weeks, when you look at annualized replase rated for 48 weeks there is no difference between Avonex and Rebif. I am not saying Rebif is not a good product, but it does not give anything more in efficacy-and don’t be fooled by their marketing adds that show the numbers as if Rebif is the best thing since sliced bread. All I am saying is really look at the data for Tysabri and speak to your doctor. If you are having breakthrough with relpapses-Tysabri gives you another alternative.

  4. Eric you bring up good points. The name Tysabri (tie-SAB-ree) which means strentgh and protection was chosen instead of Antegren because there is another infusable product that is to close the sound of Antegren, that is Integrelin (used for ACS). You can wait to use Tysabri, however you will be missing out on the 66% reductions in relapses and the shutdown of the disease. Look at the one year MRI data-its great. Just to so you are at ease-the safety data on Tysabri is a median of 20 months and the efficacy data is 13 months. I have spoken to at least 30 MS patients who will all be taking Tysabri. They are feed-up with injection site reactions, side effects, and only getting a 30% reduction in relapses. Over 200 patients in the Tysabri studies. Serono is bad mouthing data because they are scared. Also for the Avonex users when Tysabri was added there was an additional 54% reduction in relapses. The time is now to speak to your Neuro and get on Tysabri. The disability data should be out in the spring. The true question is why did the FDA approve Rebif. All Rebif showed was they had a greater effect on relapse free days through 24 weeks, when you look at annualized replase rated for 48 weeks there is no difference between Avonex and Rebif. I am not saying Rebif is not a good product, but it does not give anything more in efficacy-and don’t be fooled by their marketing adds that show the numbers as if Rebif is the best thing since sliced bread. All I am saying is really look at the data for Tysabri and speak to your doctor. If you are having breakthrough with relpapses-Tysabri gives you another alternative.

  5. This last comment from Anonymous is suspicious on a number of levels. I’ve posted a response here:
    http://home.comcast.net/~eriksmithtx/blog/2004/11/astroturfing-for-tysabri.html

  6. I find that comment suspicious, too. A pharm rep, perhaps?

    On another note, I agree with you, Erik. I don’t try any drugs until they’ve been on the market for at least a year, or I get significantly worse (and therefore, significantly more desperate).

  7. For those of us who have not been able to tolerate the ABC drugs and have had reactions to IVIG and steriods this med may be a blessing. I will be meeting with my doctor on Thursday to begin this therapy. Yes I am concerned about the possible side effects but I am more concerned about my health and the fact that I feel like crap most days. I am currently on methatrextate and that seems to have had some benefit but it has not stopped the relapses. Sometimes some of us need other treatments and I guess we are all gueinea pigs when we have this disease.

  8. Regarding the “Anonymous” who posted the info praising TYSABRI, I doubt s/he’s a Pharm rep – as certainly they would not have gotten the number of TYSABRI patients so wrong! According to press reports, over 2800, NOT 200, patients have received TYSABRI, mostly for MS but some for Crohn’s.

  9. Hey Paula,

    Erik would totally agree with your assesment. Erik is provided the “luxury” of not having to jump right on it. This summer when he had gotten pretty bad again, and had been suffering with constant “small” exacerbations since the end of the previous year, without a break, and our hope was that Tysabri (antegren) would be approved soon. Luckily the steroids did there magic, at no small cost to Erik’s mental health, and he is on the longest stretch of good MS health since his diagnosis. I praise God for that and that we can wait for now. I will be praying for you that things get better soon.

    Please keep us posted on how you are doing, if you don’t mind, and let us know how you feel about the drug from a first person perspective. I promise there will be a lot of people intersted.

  10. Hey Eriksgirl,

    Thanks for your response to my post. I hope that I did not come across in a negative way in my post that was not my intention. I am grateful that I came across Erik’s blog page it has a lot of information that is helpful to the MS community. I am glad to hear that Erik is having good health and that the steroids have worked for him.

    I will be calling the doctor on Thursday to make sure the drug will be delivered so that I can begin my treatments. I’m in the trial program for the first patients to receive the treatment so the meds will be covered by the hospital at first. I will get them for the first four months at the MS Center then continue treatment at home with a home healthcare nurse.

    I will keep you all updated on the progress of the treatments. I will be using Tysabri in conjunction with the (chemo) Methotrexate. Until then take care.

    Paula

  11. I’m a 36yr old female with 5 kids still at home. I tried all the other shot’s, the bee stings too. I had allergic reactions to all the above. But really do I want to chance my fait to a couple of lab rats, or wait for more studies to come out? I”ve had this monster since I was 23/24 was my xmas gift that yr. Great present, couldn’t even return it for something else. But I deal with it. But when you got secondary/chronic progressive (depending on what dr you talk to) what are you suppose to do?

  12. Betty,
    I know none of the current RRMS treatments are “sanctioned” for progressive MS though a lot of them are currently going through studies and do look promising. Except for primary progressive since that is really a different beast.

  13. the serono company is creating suspicion of tysabri, but without any facts to back it up,
    there concern about rebound after discontinuation of tysabri was already addressed in the phase 2 trials of tysabri, and the answer is , there is no rebound effect.
    as far as the issue of progression of disease in the tysabri trial, this was not assessed at the one year mark , because that is too short a time span, It will be assessed when the 2 year data is released spring 05. I think it will demonstrate slowing of progression. I think serono is rightly concerned about loss of market share. So far the data support tysabri as a great drug.
    about 66% reduction of relapses vs. all previous trials of ms drugs
    (copaxone, rebif, avonex , betaseron) showing about 33%.
    TWICE AS GOOD IN REDUCING RELAPSE. twice as good doesnt happen too often in medicine.
    I am recommending tysabri for many of my ms patients.
    he, MD

  14. I was interested in Paula’s comment that after 4 treatments at MD office, she would continue at home. I work at a home infusion company and we have approached MD’s about home infusion of this drug with us sending a nurse to do the infusion. Some have told us that Biogen is not recommending home treatment at this time. I am curious as to what patients think and feel about the potential of infusing at home?

  15. FIRST TYSABRI TREATMENT FRIDAY 1/7/05, I was a little scared, all went well no reactions no headache a piece of cake.

  16. biogen is not recommending home infusion of tysabri because of the potential of reaction to the infusion. About 1-2 % allergic reaction rate.
    this typically occurs during the first few infusions, so if you get through those you are probably home free, but I still dont think home infusion would be recommended
    he. MD

  17. I have a friend who has been on Tysabri for over 2 years now and she has a greater quality of life. I wouldn’t say the drug Tysabri makes things necessarily better, but it does slow further progression. I have noticed that my friend chatters quite a bit after she has her medicine. The only thing I caution on, is do not drive after you take this drug. My friend wrecked three cars and all three were within the week of the Tysabri medicine. Use caution.

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