Tysabri for Crohn's disease approved by the FDA on 1/14/08

Thanks, Lauren... I've been waiting for that news since June. Wasn't sure I'd make it intact, but I did! I will be trying Tysabri as soon as my doctor has it available. They need to be "approved" as an infusion lab too.

it still scares the sh** out of me. If there weren't so many drugs in the pipeline, I would maybe consider this. I'd be interested in hearing from people who failed Remicade, Humira, Imuran, that had a success with Tysabri.

How has this helped your MS mslady?

s5599 come on, this is the second post that I have seen from you and you seem to get upset because someone is expressing a view different from yours on Tysabri. We are all entitled to our opinions. Many have fears about this medication and they have the right to express those fears too. This medication has had a rocky past, so for me I will take a wait and see approach! JMHO!

frankj I agree that we are entitled to our opinions. My point was his first statement. "support people, thats what we're here for". It seemed to me that he was getting upset because Kasper and Kenny stated that this drug frightened them and didn't support his enthusiam for the med, a opinion they too are entitled to. I was in no way belittling anyone.

And let me all say that we have very much benefited from your comments, input and caring here. Thank you, Nanners!

I am scared of Tysabri too. Who wouldn't rationally be scared? I guess what I really mean is that I come to this forum hoping for encouragement and support from others who also have Crohn's and might understand how difficult it is to have exhausted every single available medication for Crohn's. I've even tried Prochymal, which also generated little conversation here. (Which is fine, it's very newly experimental.) But, I have been sitting waiting since June, hoping to avoid permanent surgery. And, when the news finally hit, I was so excited and wanted to share it with others I thought might benefit, be interested or just understand the excitement of a new option for treatment. The only responses in that thread were of the "I wouldn't touch it" nature. While there is nothing wrong with a personal opinion and feeling of not wanting to ever have to resort to such a dangerous drug, I guess I just felt let down as no words of support were mentioned in the first responses. The point is not that it's not a scary drug, it is. The point is that we now have another tool. And, we desperately need more tools.

I wish everyone well. It is certainly not my intent to flame anyone. I just felt sad that the group I thought would certainly understand my relief at the approval was not a source of support.

Best wishes...

It's really hard to feel encouraged about any med that has in the past had such negativity with it...it should not be a surprise that there wouldn't be a whole lot of support for this particular drug, especially when there are other drugs on the horizon (there are posts about it and I postd the link in this thread up above) that actually are encouraging, now those are the ones to get excited about.

:)

Hi s5599,

Am so happy for you! My MS has been stable for over a year, no relapses and no disease progression, thank God.

While it is understandable that there are patients who are afraid of Tysabri, the only thing I can do is post correct information about the medication. I respect to each of you, and I respect the medication and therapy of your choice. And if that works for you, then that makes me glad.

I feel a little odd posting on the Crohn's forum because I don't have CD, I have MS. I just happen to be on Tysabri therapy, know a little bit about Tysabri from researching this medication for over 8 years and I am familiar with it's undeserved troubled past.

That being said, please know that the Crohn's patient in the Tysabri trials that passed away was severely immune compromised. The FDA ruled the Primary Suspect for his death was Remicade, not Tysabri. The secondary suspects were listed as Azathioprine (which he had been on for years), immunosuppressants, and then Tysabri with concomitant immunosuppressants. In my opinion, one has to take this patient's cumulative medical history into account, and not just point the finger at Tysabri. So it is easy to understand from a patient point of view why some would be scared when they don't know the accurate facts regarding Tysabri.

In any event, I wish all of you nothing but the very best that life holds for each of you.

Lauren

Thanks again, Lauren,

What happened was really scary, but all of these drugs are pretty hard-core. A two to three-fold chance of lymphoma with Remicade is not something to overlook or take lightly. Once Tysabri was put back on the market in '06, enforced as a monotherapy, the safety rate was much different. I believe there are somewhere near 21,000 Tysabri patients worldwide (http://www.elan.com/News/full.asp?id=1091942) and there have been no new cases of PML. However, it is an extremely new drug and long term data is not available. I guess I will, again, be one of the stats...

I am so glad to hear from a current Tysabri patient... Thanks again!

Regarding Prochymal, as I posted previously, it worked great (amazing) for the first segment of the trial I was in. Within 28 days I showed a 50-60% healing (Day 0 and Day 28 colonoscopies) along with a 130 point drop in CDAI. While my fistula did not close, it barely drains now compared to before.

Since I was re-randomized for this second round of the trial I have experienced no benefit. I am assuming (for many reasons, including infusion reactions) that I received the placebo. Considering I live in Portland and the trial is in Seattle (a 3.5 hour drive) and I am almost done with treatments, (and not receiving benefit) I think I am going to drop out. I just got word that they are NOT going to reimburse my hotel costs (which is different than originally stated, but that's a different story.) The treatment is a 5-hour process due to study protocol rules of observation, and I cannot see making a 12 hour day to drive up and back for a single treatment...

Anyway, I have remained stable from the first 4 infusions (of which I am certain were the real cells). To me that is the second amazing thing. It's been 3 months since my last infusion in that phase (randomization) and I have remained stable... My score has not gone up and symptoms remain tolerable, bleeding is still intermittant. They are on fast track designation, so I can only hope it happens fast. My hope is that I will only need to be treated with Tysabri until Prochymal (or some other better option) becomes available.

Well I am one who has exhausted ALL options (besides Tysabri) and am actually heading to the MAYO CLINIC this month. I will have to bring back ALL I learned with me and share it with everything. I will find out more about Tysabri as well. In another forum I mentioned it scared me. No lack of support for you, just sharing how I personally felt. I am one who gets every Negative side effect from every medication and that is why I feel that way. Scary to me, that's all! Most all drugs are to ME but this one scared me for some reason.....

Good Luck To You! Please keep us all posted!