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

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msladyinca
Regular Member


Date Joined Jun 2007
Total Posts : 26
   Posted 1/15/2008 5:33 PM (GMT -7)   
Hi everyone, it's been awhile since I've been back to the Healing Well forums. I don't have Crohn's disease, but I have Multiple Sclerosis, and I have had 16 Tysabri infusions thus far.

I thought you all might be interested in knowing that the FDA approved Tysabri yesterday for severe to moderate CD.

In keeping with the forum rules (I don't want to break any of them), I won't post the full article, so here's a link to the full article by the company that discovered Tysabri (I don't know how to post a link here, but this is the full URL that can be copied and pasted into your browser): http://www.elan.com/News/full.asp?id=1096281

But it does stayed in part, "TYSABRI is now approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha...The companies anticipate TYSABRI will be available to Crohn's patients by the end of February 2008."

I'm just so happy for all of the CD patients that will be electing to treat with Tysabri in order to avoid further surgeries or cannot tolerate other CD therapies. I pray that they will receive outstanding benefits from Tysabri.

But whatever therapy you are on or will be on, I pray that it too works for you.

All my best to everyone here,

Lauren :-)
Our Todays are only stepping stones for our Tomorrows

You can visit My Tysabri Diary by going to: http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/

Post Edited (msladyinca) : 1/15/2008 5:49:27 PM (GMT-7)


sr5599
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Date Joined Aug 2007
Total Posts : 1202
   Posted 1/15/2008 9:22 PM (GMT -7)   
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.

pb4
Elite Member


Date Joined Feb 2004
Total Posts : 20576
   Posted 1/15/2008 10:09 PM (GMT -7)   
This post from Reef sounds better anyways...
 
 
 
:)
My bum is broken....there's a big crack down the middle of it!  LOL  :)


Kenny23
Regular Member


Date Joined Aug 2005
Total Posts : 128
   Posted 1/15/2008 10:27 PM (GMT -7)   
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?

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 1/15/2008 10:38 PM (GMT -7)   
support, people. that's what we're here for. CD patients who have exhausted all currently approved meds (not to mention clinical trial opportunities) such as myself are looking forward to another tool. We need more treatment options. There have been NO new cases of PML since it was re-approved as a monotherapy.

Nanners
Elite Member


Date Joined Apr 2005
Total Posts : 14995
   Posted 1/16/2008 9:42 AM (GMT -7)   
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!
Been living with Crohn's Disease for 32 years.  Currently on Asacol, Prilosec 60 mg, Estrace, Prinivil, Diltiazem, Percoset prn for pain and Calcium.  Resections in 2002 and 2005.  Recently diagnosed with Fibromyalgia and doing tests to see if I have Inflammatory Arthritis or AS.


frank j
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Date Joined Jun 2006
Total Posts : 341
   Posted 1/16/2008 9:54 AM (GMT -7)   
with all due respect, Nanners, s5599 was expressing an opinion, just like we all have a right to do. It just happened to be an opinion in support of the drug, as opposed to expressing fear. I personally think that s5599's post was a respectful communication of an opinion made without belittling any other comments, IMO!

Nanners
Elite Member


Date Joined Apr 2005
Total Posts : 14995
   Posted 1/16/2008 10:27 AM (GMT -7)   
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.
Been living with Crohn's Disease for 32 years.  Currently on Asacol, Prilosec 60 mg, Estrace, Prinivil, Diltiazem, Percoset prn for pain and Calcium.  Resections in 2002 and 2005.  Recently diagnosed with Fibromyalgia and doing tests to see if I have Inflammatory Arthritis or AS.


frank j
Regular Member


Date Joined Jun 2006
Total Posts : 341
   Posted 1/16/2008 10:30 AM (GMT -7)   
I hear you. Just trying to point out that there are always two ways to interpret statements and that we all, me included certainly, can misinterpret postings on the internet since we don't have the benefit of inflections, etc.

Best,

frank

frank j
Regular Member


Date Joined Jun 2006
Total Posts : 341
   Posted 1/16/2008 10:31 AM (GMT -7)   
And let me all say that we have very much benefited from your comments, input and caring here. Thank you, Nanners!

Nanners
Elite Member


Date Joined Apr 2005
Total Posts : 14995
   Posted 1/16/2008 10:38 AM (GMT -7)   
I think we were trying to point out the same thing! HA! And thank you Frank for your kind words. We all may not always agree, but I think we can peacefully agree to disagree sometimes.
Been living with Crohn's Disease for 32 years.  Currently on Asacol, Prilosec 60 mg, Estrace, Prinivil, Diltiazem, Percoset prn for pain and Calcium.  Resections in 2002 and 2005.  Recently diagnosed with Fibromyalgia and doing tests to see if I have Inflammatory Arthritis or AS.


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 1/16/2008 12:33 PM (GMT -7)   
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...

Nanners
Elite Member


Date Joined Apr 2005
Total Posts : 14995
   Posted 1/16/2008 12:56 PM (GMT -7)   
s5599 as a fellow Crohnie I understand your excitement and respect it. Especially with the difficult time you yourself are going thru. If it works for you I will be VERY happy, happy that you and others finally get some relief. But also please understand, this medication will draw some doubters, because as you are aware, its also had a bad history.. So while we hope it turns out to be a magic medicine for all of us, please understand that many us aren't too optimystic YET. But we do definetly support you, don't ever doubt that.

God Bless,
Gail*Nanners*
Been living with Crohn's Disease for 32 years.  Currently on Asacol, Prilosec 60 mg, Estrace, Prinivil, Diltiazem, Percoset prn for pain and Calcium.  Resections in 2002 and 2005.  Recently diagnosed with Fibromyalgia and doing tests to see if I have Inflammatory Arthritis or AS.


pb4
Elite Member


Date Joined Feb 2004
Total Posts : 20576
   Posted 1/16/2008 1:08 PM (GMT -7)   
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.

:)


My bum is broken....there's a big crack down the middle of it!  LOL  :)


Reef08
Regular Member


Date Joined Dec 2005
Total Posts : 267
   Posted 1/16/2008 2:58 PM (GMT -7)   
s5599,

What was your experience with Prochymal? Is the trial over?

msladyinca
Regular Member


Date Joined Jun 2007
Total Posts : 26
   Posted 1/16/2008 4:43 PM (GMT -7)   
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 :-)
Our Todays are only stepping stones for our Tomorrows

You can visit My Tysabri Diary by going to: http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/

Post Edited (msladyinca) : 1/16/2008 6:38:38 PM (GMT-7)


Kenny23
Regular Member


Date Joined Aug 2005
Total Posts : 128
   Posted 1/16/2008 6:13 PM (GMT -7)   
Don't get my comments wrong, I do support people like you with no other options. I'm also sure that me saying I'm scared of a drug would not influence your decision of trying it. Heck, maybe Tysabri will prove to be a fairly safe drug when used correctly. Maybe the clinical trials worked out any safety kinks.

From my personal view, the published reports on efficacy barely balance the risks. But I do understand that some people feel much better and for them the clinical trials mean nothing.

Sure, having new drugs is great, but at what point do we consider not only risks, but also future pipeline drugs that are probably safer?

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 1/16/2008 6:20 PM (GMT -7)   
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.

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 1/16/2008 6:21 PM (GMT -7)   
Oh, and Kenny, I cannot wait for future options. I have no drugs that work now and have already been on steroids for 6 months. Thankfully Prochymal allowed me to taper off. My docs wanted to do a permanent ileostomy last summer...

Shari

lovepink
Regular Member


Date Joined Sep 2007
Total Posts : 182
   Posted 1/16/2008 7:17 PM (GMT -7)   
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!
I have had Crohn's since I was 21 years old and I am now 27....

On HUMIRA....


hspenser
Veteran Member


Date Joined Dec 2005
Total Posts : 544
   Posted 1/18/2008 9:38 AM (GMT -7)   

I was on Tysabri for a fairly long time...the change in my symptoms was immediate and nothing short of amazing.  I gained almost 100 pounds in a year because I just ate and ate.  I was almost 100% free of my symptoms...but would start to feel them pushing to start again every four weeks...then a new infusion and bingo, right as rain.

This also means that the drug did not cure me, it only put me in remission for a short time...once the trials were stopped I lost the 100 lbs plus a few more and have been "hot" for over 2 years.

That said...I have absolutely no fear or angst starting back up and will do so ASAP.


dx IBS 1999   UC 2000   CD 2001
Tested BIOGEN TYSABRI (gave me 2 years of remission)
currently on Low Dose Netroxene (started Jan. 19, 2007)...against Dr's wishes, he was pushing for Remicade.  Stopped the Naltrexone July 28th...started Humira Aug 31st, 2007...current dose two shots every other week.
Crohns is currently active and has been since April of 2005
51 yrs old

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