Tysabri worked GREAT for ME

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Terry in Virginia
New Member


Date Joined Oct 2007
Total Posts : 9
   Posted 1/17/2008 10:26 AM (GMT -7)   
Greetings all:

I am THRILLED that the FDA has finally re-approved Tysabri as a treatment for Crohn's Disease. From the posts here over the past couple days, I know some of you have valid fears and concerns about this drug.

My take on it: I was in the Phase II and Phase III clinical trials for this medicine. In Phase III, I had an infusion every month or two (can't remember the exact schedule) for 18 months until the drug was yanked by the FDA. As I understand it, 3 people (out of about 3000 in the study) had the neurological illness, and 2 of them died. Everyone in the study was asked to get an MRI of the brain.

To my knowledge, it has never really been confirmed that the drug had anything to do with this terrible tragedy. But for me, even if it was the cause, I would still want Tysabri for my CD.

Why? Because it is the ONLY medicine I've ever had that gave me terrific results for Crohn's. I measured an 80% improvement in my symptoms. By that, I mean that prior to Tysabri, I was in a full-on flare up roughly 25 days out of a 30 day month. After a couple of months, I only had bad days maybe 5 days per month. A very dramatic improvement. Would I risk a 1% chance of death to get those results again?

Yep. In a New York minute.

Also, I stayed in this "almost remission" stage for at least 6 months after I was forced to stop the medicine.

As of now, I've been in a major, almost non-stop flare-up of CD for 14 months. Absolutely NOTHING has helped. Immuran -- gave me pancreatitus. Humira -- gave me a severe body rash and did not relieve my symptoms. Remicade -- I've had 2 infusions so far -- with absolutely ZERO results. Meantime, I'm missing work, at risk of losing my job, had to cancel Christmas, New Year's Eve, and my own birthday party, and pretty much every other social activity for the past 2 months. I'm just sick 24/7. I can't stand it anymore. I'm currently on 50 MG of Prednisone that BARELY impacts my symptoms at all.

Today I am seeing my GI. I'm going to DEMAND that he increase the dose and/or frequency of my Remicade infusions for now. If it works out later, great. But if I don't see any improvement by the time Tysabri becomes available again (end of Feb or early March, sounds like),. then I plan to switch to Tysabri as soon as medically feasible. I'll probably need a 4-8 week break between these biological drugs.

I've been waiting for this announcement for 2 years. I've been suffering horribly == this 12th year of CD has been the worst ever. I want my life back.

Just my 2 cents. BTW, as we all see here, Humira and Remicade and the other new-age drugs often have terrible side-effects too. I'm glad they benefit many of you here. Maybe it's MY turn for some relief ..... a couple months away. Hope so.

Cheers and good fortune to all....

Terry in Virginia

Pampers
Regular Member


Date Joined May 2007
Total Posts : 76
   Posted 1/17/2008 11:02 AM (GMT -7)   
Hearing your story was hard for me. I feel for you - to be in a constant flare is so humiliating and painful. I am in the same boat - I've been in a flare now for over a year. Sometimes I think I'm getting better, but any releif only lasts a few days. Hang in there and know that you are not alone. I'm glad that they have re-approved that drug for your sake, if must be a releif to know that the medicine is now within reach.

And thank you for posting about this drug, I am about to start Humira and I had never heard of Tysabri. Its nice to know there is something beyond Humira I can try if it fails like the rest of the meds...

Best of luck to you.

Heather
Diagnosed with UC 8 years ago
Asacol / 12 per day
Canasa / 1 per day
Rowasa / 1 per day
Prednizone / 40 MG Day( finished taper!!!)
Azathioprine / 100 MG Day
Levaquin 1 per day
Flogyl 1 per day
Diagnosed with Crohn's 6/26/2007
 
 


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 1/17/2008 12:21 PM (GMT -7)   
I've been in a constant flare for over a year too.  I could so relate to your list of experiences!  I have missed all sorts of events (Grandfather's funeral, high school friend's wedding, annual camping trip family reunion, anything that required leaving the house for any length of time).  I also rejected Imuran, 6-MP and MTX.  Remicade quit working then I had an allergic reaction (hives in my mouth!) and Humira never really worked at all.  Prochymal has helped but there is nothing more to that trial until it is approved and that looks a couple years out.  With my bleeding and symptoms, I can't wait...  I am fortunate to work from home most of the time (web stuff), so I have not had to quit work.  (Thankfully, as a single mom!!)
 
I am so thankful that Tysabri will offer hope.  My doctor told me that the effects are long lasting, your story reminded me of that.
 
It's very scary, but honestly, I am trying not to focus on that.  I feel the same:  it's my turn to actually respond to a drug and get my life back.
 
Shari
 
--39 year old single mom, dx 1/03 -- 2 yrs of remission before Remicade stopped working, constant flare the rest of the days.

stkitt
Forum Moderator


Date Joined Apr 2007
Total Posts : 32602
   Posted 1/17/2008 12:25 PM (GMT -7)   

Terry
Thank you for sharing your story with all.  It is good to hear from someone who has been on the drug already.  I hope you are soon back on it if that is possible. Keep posting.


 
Kitt, Co-Moderator: Anxiety ~ Panic  ~ Crohn's
*~* http://www.healingwell.com/donate *~*
It is health that is real wealth and not pieces of gold and silver.~Mahatma Gandhi~
 


frank j
Regular Member


Date Joined Jun 2006
Total Posts : 341
   Posted 1/17/2008 2:54 PM (GMT -7)   
Thanks Terry

FitzyK23
Veteran Member


Date Joined May 2005
Total Posts : 4219
   Posted 1/17/2008 7:34 PM (GMT -7)   
I hope you get your drug asap. Personally I think we should all be allowed to assume a risk. If we are properly informed of a risk, no matter how severe it is or how likely it is, I think it should be up to us if we want to take that chance in an attempt to have our lives back. In assuming the risk you would waive your right to sue. And it would be your own gamble to take. I understand drugs need to be FDA approved before they are offered to the public but if risks come up I don't think it is fair to those that it helped for it to be just yanked. I am all for assumption of risk and informed decision.
26 Year old married female.  Diagnosed w/ CD 3 years ago, IBS for over 10 years before that, which was probably the CD.  Currently on Pentasa 4 pills/4x day, hysociamine prn, nexium, and ortho evra.  Good times!!!
 
 


mcleaver1969
Regular Member


Date Joined Jun 2006
Total Posts : 267
   Posted 1/17/2008 7:39 PM (GMT -7)   
Terry,
Thank you so much for your views on Tysabri...I had never heard of this CD treatment before a few days ago, it's such a relief to read your post because you have been treated with Tysabri and your results were so good, eases my mind a lot, I will definately talk to my GI about it. I am willing to take the 1% risk if it will alleviate the CD symptoms that well. Good luck to you and I hope you feel better soon. Take care!
Marci, 38 years young, Rockledge, FL
Dx with Crohn's disease March 2006
Currently on bi-weekly Humira, daily 6mg Entocort, daily 2-3x 5mg hydrocodone (for pain), and daily 75mg Effexor,
plus 3x per day heavy iron supplements for anemia,
calcium supplement, daily multi-vitamin,
Lasix as needed for ankle/feet swelling
Self-proclaimed "recluse"  do to CD  ;)


hspenser
Veteran Member


Date Joined Dec 2005
Total Posts : 544
   Posted 1/18/2008 9:22 AM (GMT -7)   
Terry...my story is much the same...I had a great response with Tysabri...I was placed in the trials pretty much from the get go...I was on the placebo for the first part and then in the second trial we are pretty sure (based on the results) that I was given the actual drug...then came the open label and there was no doubt....when it got yanked I went into a tail spin and have not had much in the way of relief since.
 
I had not heard that they were ready for general release...last I heard (about 4 months ago) was that they were ready to start up the trials again.  The doctor from Shands Hospital in Gainesville FL called and asked if I would like to be in the trials again...I had just started Humira and we decided to wait and see if it worked.  It has only given minor help by increasing my nutrient absorbtion ability...but no relief in the cramps, big D or other areas...so I will be calling the Gainesville office to find out where things stand.
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


msladyinca
Regular Member


Date Joined Jun 2007
Total Posts : 26
   Posted 1/18/2008 6:34 PM (GMT -7)   
Hi everyone, just thought I'd stop by and drop off a link where you can read the CD testimonies of the following patients: Melissa Arnett, Dr. Doug Wolf and Dr. Bruce Sands (both gastroenterologists), and posted below is the most powerful testimony of Lisa Casanova, all which were given at the Tysabri trials in March, 2006 (in which I testified via videotape for MS) Take good care everyone, Lauren:

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4208T1.pdf

"MS. CASANOVA: Good afternoon. My name is Lisa Casanova. I own no stock in Biogen Idec or Elan Pharmaceuticals. My trip here was paid for with my credit care.

There has been a lot of talk at this meeting about the patient, the Crohn's patient. I am 29 years old and I have had Crohn's disease since I was 7.

I was a participant in the Phase III clinical trial and open label trial was natalizumab at the University of North Carolina, Chapel Hill. I am here to tell you to bring Patients [Tysabri].
When I enrolled in the [Tysabri] trial, it was because I was looking for options. I had a very inflamed stricture and my colon was making me verysick. I knew that I was going to need surgery to remove it. That was inevitable, but I was looking for choices to allow me to delay that.

When I enrolled in the [TY] clinical trial, it was a wonderful drug. I started to get better almost immediately. I know objectively that I was getting better, because my gastroenterologist would examine the stricture, I knew that it was getting less inflamed, and I felt better, my quality of life improved.

I was able to do things like get through an entire day of work without trip after trip to he bathroom. Most people take that for granted and don't know what it is like when you are everything and run off to the bathroom because, of course, you have a mental map in your head of where every single one is, and hope that it is available, so that you have a place to wait out the pain and the nausea just so that you can go back to work and get through the day.

[With TY] I was able to work, I was able to make significant progress toward my Ph.D., and do the things I wanted to do like be able to sit through an entire class lecture, to be able to play a string instrument because I could last through a whole concert.
When Tysabri was taken off the market, I couldn't have it anymore, I started to get worse again, I was getting sicker, I was in pain, the inflammation was getting worse, and I knew it was time for surgery.

So, I went under the knife in November of last year [2006]. I had a sigmoidcolectomy, and I ended up with an anastomotic leak and an abdominal abscess that took six months to heal. I was let out of the hospital with a pick line and an abdominal drain that drained the contents of my intestine into a little container that I carried around in my pocket in any attempt to heal it.

I was so sick my mother came to live with us, and she would pat me and tell me what a good day I had had on the days when I could get up, take a shower by myself, and push the grocery cart around the store while she shopped. That is what recovery from surgery was like for me.

Did I know the risk before I went under the knife?

Yes, I did. I understood the risks just like I understood the risk when I enrolled in a clinical trial of an experimental drug [TY], and if I could go back and do it again, I would make the same choices. I would do it again.

The risks that I took are the reason that my life is moving forward and it is always going to be that way for me. I mean I am 29, I am going to have Crohn's disease for the rest of my life, and I am facing that continual choice between one risk and another. I would love to have completely effective treatments that had no dangerous side effects, but that only exists in some fantasy world. In the real world, like I said, I do ok

Remicade, which has its risks of infection. I maintained on azathioprine, which has its risks of liver damage, of infection. Both those drugs have long-term risks of lymphoma that we understand only poorly. Right now I use biphosphonate with all their attendant risks to treat the osteopenia that

I have from years of corticosteroid therapy. I dropped below the fracture wrist threshold when I was 25. So, that is what it is going to be like for me, a tradeoff of one risk for the benefit that I can get out of any given drug.

If you bring Tysabri back on the market, are the risks significant? Yes, they are. If that means that it has to be in a strictly regulated program like the RiskMAP that they have described here, then, that is the way it should be, because that is an acknowledgment of reality that risk can never be eliminated, it can only be managed, and we deserve the chance to assume that risk in exchange or the benefit that we can get."
Our Todays are only stepping stones for our Tomorrows

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


Dave123
Regular Member


Date Joined Feb 2005
Total Posts : 223
   Posted 1/21/2008 7:27 AM (GMT -7)   
I have a similar experience with Tysabri. I was in the trial for a short time. For the first few months I believe I received placebo (nothing happened), but for the 3 months I was in the open label - WOW. The best I had felt in 5 years, maybe ever since I was diagnosed. I was pretty bummed when the trial was pulled and I too went back into a tailspin.

I am glad tysabri was approved. I've been feeling pretty good over that last year or two, following another clinical trial (adacolumn), so I wouldn't use tysabri now. But, if I went back to the place I was in a few years ago, I would seriously consider it, even with the risks. There is something in tysabri that has a dramatic affect for some of us, when no other drugs seem to.

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 1/21/2008 8:19 AM (GMT -7)   
Thank you all for posting your experiences and those of others. It really brings hope for me.
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