Deciding on Tysabri

[sammy67]

Hello,
I am new to this forum and am glad i found this place. Here is my situatioin. I have MS, dx almost 5 yrs ago. I also have Crohn's disease, 8+ yrs. I have been on Rebif and Betaseron with no luck. Very sick most of the time and continued with relapses. I have not been on anything for about a yr now. My MS doc wants me to try copaxone. the problem is wiith my Crohn's i have only one drug left i can take ( 6MP ) that wont hurt the MS. My Crohn's Dr. thinks I am a good candidate for Tysabri but my nereo thinks its too high of a risk drug and i need to have tried at least 3 other MS drugs not 2 as i have. I am tierd of being pummed with steroids and at this point with all i have read on Tysabri, that i am a good candidate for it. I understand why my MS doc is conserned with the risks, but i think it is a greater risk mixing the copaxone with the 6MP not knowing what the risks of that may be. dont know of anyone who has mixed that cocktail as of yet. I would love to hear some of your input, maybe how any of you came to the decision of going on Tysabri, weighing the pro's and con's.
any input i am sure will be helpful.
Thank you
Sammy

[ewizabeth]

Hi Sammy, and welcome,

Tysabri is used to treat MS and Crohn's. If I were you, I think I'd want to use that instead of Copaxone.

Your neurologist is wrong (I believe), you do not need to fail 3 prior treatments to use it (as far as I know.)

I think that with your two diagnoses (MS and Crohn's), your neuro should be able to RX Tysabri for you, and I don't know why your insurance would disagree.

As long as he follows the protocol for administering Tysabri it should be ok, unless you're on other meds that would disqualify you.

Good luck with whatever treatment you end up using.

[rkm2828]

I think your crohn'd doc is right. You are a good canidate for Tysabri because it can have a profound effect on both MS and Crohn.

Tysabri is not officially approved for Crohn yet but it is for MS. There are currently about 12,000 MS patients worldwide who are on Tysabri and some of them are getting improved quality of life, i.e. improved balance, more energy, less fatique, more endurance, can get up from wheelchair, etc.

FDA advisory panel will review Tysabri for Crohn in July. It may or may not recommend approval at that time. The chances are the panel will recommend for second line approval.

In the meantime, if you want to get on Tysabri, your MS doc need to prescribe it. You may benefit for both of your terrible disease. Your MS doc needs to be 'touch' certified.

[sammy67]

Thank you both for respondiing. I have written emails to all of my doctors askiing all of them to talk. it is hard having different doc's all needing to work together. It is interesting to me that my Crohn's doc is the one who wants me on Ty, and my MS doc does not. He feel's the risk is too high. I don't think i agree with him. I am hoping today they will all speak ( or sometime this week ) and decide i am a good candidate for this drug. again, considering i have both MS and Crohn's and that seems to be what this drug is made for, and works. Again, i feel frustrated that i feel like Ii have to be my own doctor, do the research and tell them what I want. but the fact remains, i am not a Doctor and I rely on them to send me in the right direction. Ii think my MS doc is just protecting himself and is just not comfy with Ty yet. he says he does have 2 patients on it, but they are in his words allot worse off then me as far as their MS goes. I keep saying, if i had one of these diseases, i may not be a candidate for Ty, but the fact that i have both, both are active and diminishing the quality of my life, i am willing to try it.
again, thank you for your insight, i look forward to hearing from more of you.

Sammy

[Loobie]

That 3 approved drugs before statement is probably from your doctor and your doctor only. I may be wrong, but it's your MS, not his. Tell him you have done your research and you want what YOU want; not him. The last two responders are correct in that I have read that Tysabri is also being looked at for Crohn's. Always remember, if you've done your research, don't take anything a Dr. tells you that contradicts what you know unless he lets you hash it out with him and he gives you a really good explanation.

[lyndacarol]

Sammy67--As you will soon learn, we all have our unique thoughts on the subject of MS; I have my own.

I do not think that MS is an autoimune disease; in fact, I am not sure that it belongs entirely to the realm of neurology. If the artificial boundaries of medical specialization were ignored and interdisciplinary cooperation were established in the research, there might be more known about this disease! After all, it was first recognized in 1868! As you wrote:

I have written emails to all of my doctors askiing all of them to talk.

Perhaps you can start this new approach with your doctors.

[sammy67]

thought i would share with you all what my neuro had to say in response to my email to my G.I. doc's

I have already shared my thoughts with everyone but she is quite insistent that we discuss openly about her case. I feel that for MS, she has not failed all the approved therapies at this time. So the use of Tysarbri is not yet indicated for the treatment of MS given the current FDA approved indications. However, if the data for Tysarbri in the treatment of Crohns' is strong, I believe Tysarbri can be used with the full understanding that we are using it not according to the current FDA indications for the management of MS. Of course, she needs to understand the risk of this treatment including the potentially fatal consequence of PML.

have not heard from the other doc's who suggested it in the first place, but i am a bit stunned at the moment. i guess we as patients should not question our doctors and "insist" they discuss together what is in MY best interst !!!

[rkm2828]

sammy67,

If I were you, I would be very careful here.

Couple of comments here, first of all, your MS doc implied that you had to fail all other MS drugs before Tysabri can be prescribed per FDA indication. That, is plain wrong. Tysabri can be prescribed as a first line treatment if the patient and the doc feels that is the best way to go. Please go to Tysabri.com and other websites to learn that important fact for yourself.

Your MS doc indicated that if Tysabri is prescribed here for you, it would be used for treating Crohn instead of MS (i.e. out of FDA's approved indication). Tysabri is not yet approved for Crohn yet, remembered ? In other words, your insurance will not pay.

So, if you are thinking of to try Tysabri for your diseases, you have to convince yourself and your MS doc to prescribe Tysabri for MS and MS only. Otherwise you will be running into all kind of problems, getting 'TOUCH' certified, etc. If so happen Tysabri also helps with your Crohn disease, it should be considered as gravy, not the sought after primary objective.

I think you need to leave your G.I doc out of open discussions. Seek his advice, yes. But not for official recommendation because your insurance may use it to deny payment for Tysabri.

All in my humble opinions only.

[Kemond]

Just my experience, but after 6 months on Copaxone (the only drug I have taken) I have started Tysabri at the urging of my MS Specialist.

[sammy67]

i think it's time to find a new Doc......

[rkm2828]

Sammy, yesterday, the advosory committee of FDA voted to allow Tysabri for Crohn patients. The final decision will come probably in October. If you still want Tysabri for both of your MS and Crohn then, you can then ask your 'GI' doc to prescribe it legitimately.

[sammy67]

Thank you,
Yes, I have been following it. I ended up changing MS Doc's after several "2nd" opinions and i am set to start Tysabri tomorrow. I am very excited and a bit scared too. I met with my GI today who is an IBD research Dr. also at a big hosp. and he feels strong that Tysabri is right for me. I sure hope he is right cause i am more then ready for some relief.
The center i am having it infused at says they have 3 others on Tysabri there and all leave feeling fine, and notice a difference usually after the 2nd infusion. i think it may take a little longer to feel a difference with the Crohn's, but the MS stuff i should see a difference in a mo or so !!! keeping my fingers crossed !!!

[rkm2828]

Congratulations. Please tell us your experience with your 1st Tysabri infusion. I'm sure many here would be anxiously waiting to hear. Thanks.

[wintergreen]

FWIW:

http://www.fda.gov/ohrms/dockets/ac/07/ ... Errata.pdf

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE - FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH

DATE: July 20, 2007
TO: Participants at the Joint meeting between the Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

FROM: FDA

SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007

"The Division of Gastrointestinal Products and the Office of Surveillance and Epidemiology provide the following corrections to the original background package submitted for the Tysabri (natalizumab) advisory committee meeting scheduled for July 31, 2007.
….
[The] FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies (e.g., as second- line therapy).

However, the indication statement does not explicitly preclude the possibility of firstline therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient."

[MaggieMae]

Sammy,

Did you receive your treatment with Tysabri? How are you feeling?