bad news for Tysabri

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hspenser
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Date Joined Dec 2005
Total Posts : 544
   Posted 8/4/2008 5:43 AM (GMT -7)   
Looks like there are two new cases of progressive multifocal leukoencephalopathy ...this was reported on Friday the 1st.  They were MS patients
 
 
 
This news while bad does not mean they will remove it from the market at this point.  The two new cases are well within the original risk of 1 in 1,000 since this is 2 out of 6,000 patients who have been on the drug for 18 months.
 
 
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


Linn
Regular Member


Date Joined Jul 2008
Total Posts : 118
   Posted 8/4/2008 6:27 AM (GMT -7)   
great. i got my first infusion on friday, after being on 60 mg of pred (30 am/30 pm) for nearly a month, and spending two weeks of that on solumedrol, tpn, 6mp, asacol, cipro and flagyl.

i can't tell if it's the tysabri or the massive dose of steroids, but i admittedly do feel significantly more energetic than i did last week. gassy, and the D is still there, but the pain is at least manageable and it doesn't look like surgery is going to happen imminently. so that's improvement.

even more reason to get prochymal out of trials and into the clinic...

hspenser
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Date Joined Dec 2005
Total Posts : 544
   Posted 8/4/2008 6:57 AM (GMT -7)   
Linn said...
great. i got my first infusion on friday, after being on 60 mg of pred (30 am/30 pm) for nearly a month, and spending two weeks of that on solumedrol, tpn, 6mp, asacol, cipro and flagyl.

i can't tell if it's the tysabri or the massive dose of steroids, but i admittedly do feel significantly more energetic than i did last week. gassy, and the D is still there, but the pain is at least manageable and it doesn't look like surgery is going to happen imminently. so that's improvement.

even more reason to get prochymal out of trials and into the clinic...
Linn,
 
As hard as it may be you need to focus on the positive aspects of the treatment.  I was on it for almost 2 years and it was the best 2 years of my "crohns" life.
 
You can also be a little pro-active and make sure that your doc keeps a sharp eye on your vitamin b levels.  Low levels of B can lead to temporary nuro issues and who needs that right now.  If the tysabri works you should probably not have any nutrient absorption issues so it maybe become a moot issue.
 
Good luck...I am sure you will be fine.
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


Linn
Regular Member


Date Joined Jul 2008
Total Posts : 118
   Posted 8/4/2008 9:17 AM (GMT -7)   
dear hspenser---

thanks for the tip
and its really heartening to hear some GOOD news about tysabri out there (in terms of your awesome two years)

fingers crossed...
24-year old Crohny, dx'd at 16.
Deferred medical school till January 09 because of most recent flare

Currently take:
Tysabri
Pred 60 mg
Nifrex


hspenser
Veteran Member


Date Joined Dec 2005
Total Posts : 544
   Posted 8/4/2008 1:10 PM (GMT -7)   
one other thing to consider...it may mean something...it just be random blind luck....but for the vast majority...the folks who are adversely affected are the ones taking it for MS...I think of all the ones affected only 1 (maybe 2) have been taking the Tysabri for treatment of Crohns.

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


Jen77
Veteran Member


Date Joined Mar 2006
Total Posts : 2691
   Posted 8/4/2008 1:59 PM (GMT -7)   
Geez, it just seems like all the treatments they're coming out with have such horrible things they can do to us. No one wants to borrow more problems.
~Jennifer
 
Diagnosed with Crohn's Disease 2/06 after sever GI bleed. Has been suffering since 1998. History of rectal fistula and gallbladder removal. Currently taking Prednisone: tapering down again at: 6mg now, Asacol, Questran, Toprol XL (for high blood pressure).


Rider Fan
Veteran Member


Date Joined May 2008
Total Posts : 1445
   Posted 8/4/2008 3:27 PM (GMT -7)   
It's nice to have the biologics as options, but I don't think they will be a long term answer for most, unfortunately. The do make the drug companies I ton of money so we will be seeing more of them I'm sure. Better than nothing but not a miracle...
Dx'ed in 1999. No surgeries.

Current meds: 75 mg 6MP. 10mg prednisone (trying to taper). Udo's Choice Probiotics (30 billion).


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 8/4/2008 6:01 PM (GMT -7)   
Wow. Thanks for the update... It makes me scared to read, not just because it happened in monotherpy cases, but also worry they might take it off the market. This disease never lets us rest... I just hope Prochymal hurries up!
 
--OK, I just read the article.  And, there is another posted by Biogen Elan:
 
I guess it won't get yanked off, but it still scares the heck out of me!!!


--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--methylpred - finally off 6/15/08, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl

Post Edited (sr5599) : 8/4/2008 7:17:53 PM (GMT-6)


Linn
Regular Member


Date Joined Jul 2008
Total Posts : 118
   Posted 8/4/2008 6:43 PM (GMT -7)   
reflecting on my experience with biologics, for me its a shame they get such a bad rap. remicade and humira got me through high school, university and grad school. i am so thankful for those years...hoping tysabri can tide me over till the prochymal hits...
24-year old Crohny, dx'd at 16.
Deferred medical school till January 09 because of most recent flare

Currently take:
Tysabri
Pred 60 mg
Nifrex


Mac_Gyver
Regular Member


Date Joined Aug 2007
Total Posts : 350
   Posted 8/11/2008 2:59 PM (GMT -7)   
Wow, I hope that this is the last we hear about this. Tysabri has finally allowed me to get back to my life.


I guess after reading tis it re-awakens my fears of PML. Bot patients were on this for more than a year, so far it's 5 months for me.
Symptoms Of Crohn's June of '06 (21 years old 285lbs). Colonoscopy in Jan '07 no sign of Crohn's.
Surgery for a Fistula in April '07, diagnosed suggestive Crohn's in May '07. August '07 small bowel follow
through, diagnosed with Crohn's (23 years old 180lbs). Off predisone and on tysabri 4/3/2008
============================================

Post Edited (FinalMacGyver) : 8/11/2008 4:06:07 PM (GMT-6)


hspenser
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Date Joined Dec 2005
Total Posts : 544
   Posted 8/11/2008 7:40 PM (GMT -7)   

Both were over 18 months and like the vast majority they were taking Tysabri to treat MS...

I don't know the dose for MS...it may be different than for Crohns.  Also I suspect that MS sufferers probably take some pretty aggressive drugs besides the Tysabri.

I was on Tysabri for over 18 months...closer to 2 years, maybe a bit more....then when the problems began they did all sorts of tests and scans on me...MRI's, CAT-Scans, blood tests till I was dry ...I drew the line at the spinal tap (the Dr. agreed that since everything was negative it was not needed)....I am thinking about moving to Tysabri at this point, but fear giving up the meager gains I have had with the Humira and additionally fear the setback that the 8 weeks of no drugs could cause me.


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


UKpup
Regular Member


Date Joined May 2005
Total Posts : 213
   Posted 8/14/2008 11:10 AM (GMT -7)   
Sorry to chime in late on this one.

I was given the choice yesterday to continue with Humira (but doubling the dosage), starting Cimzia, or starting Tysabri. I don't know what it is about Tysabri, but it just scares me to death. I understand most of the horrible issues have been in MS patients, but still......

I ended up going with Cimzia. I've been on Humira since May 1st and it's done NOTHING for my symptoms. During the Humira trial last year, I tried going to a double dose, but it didn't do anything at that time either. Since Cimzia and Humira are in the same class, my GI doesn't think it will do anything for me either. But Remicade is the same type and it was a WONDER drug for me.....I felt great while I was able to take it.

I don't know, I just can't make myself try the Tysabri.

pup
The funny story of my first abscess


******************************************
"I've got a fever and the only prescription is more
cowbell." --Christopher Walken
******************************************


hspenser
Veteran Member


Date Joined Dec 2005
Total Posts : 544
   Posted 8/14/2008 11:37 AM (GMT -7)   

I know takling Tysabri would be very scary...even though I was on it for a long time I know that if I go back on it I will be very nervous for a long time.....

I admit that even now...a couple of years later I still wonder if something bad could occur from my having been on it.

That said....I feel certain that I will go try to go back on it very soon...simply because the relief it provided me was fantastic...unmatched by anything else I have ever tried.  the quality of life it afforded me is IMO...for me...worth the risk....maybe even worth double the risk.


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


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 8/14/2008 12:42 PM (GMT -7)   
I'll say that it's been making me incredibly nervous. hspenser, you were in the trial and I think you got info on being off it for a while and then starting back up. I called Biogen/Elan and the person was not super knowledgeable... I felt like she was reading the booklet to me, which I clearly have nearly memorized by now! ;-) But, I was hoping to get a re-cap on what you learned.

I'm still curious if it's really the Tysabri that is making me so well. I was a week after my 3rd infusion and my fevers were coming back, bathroom trips at least 15 times/day, lots of blood, pain, etc. A week after starting the Xifaxan and budesonide suppositories, I got "well"! Now I am off both of those and just on Tysabri. I am back to 8 bathroom trips a day, but still minimal blood/pain... no fevers. If I use a suppository, I only have 3 bathroom trips per day...

So... Part of me would LOVE to go off the Tysabri for a couple months and just try the Xifaxan and budesonide suppositories (they're compounded 3mg wax suppositories)... just to see what happens. What if I am taking Tysabri and it's NOT worth the risk? What if it's really the suppositories that are helping? (Most of my inflammation is in the lower 12" and especially the rectum.)

And, I was thinking my fistula might be closing, but I felt gas through there the other day for the first time in weeks/month. I can't help but wonder... was it the Xifaxan... BUT stopping Tysabri and risking losing it as an option is scary too!

Thanks for "listening" to my vent/ramble!
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--methylpred - finally off 6/15/08, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08
--single mom to 10-yr-old girl


jid
Regular Member


Date Joined Apr 2005
Total Posts : 103
   Posted 8/14/2008 7:33 PM (GMT -7)   
My Dr called me when the reports were announced. He described it to me as 2 more out of over 40,000 patients on Tysabri. I'm about to be on my 7th dose and I think i'm the only one of the 6 people in the infusion center who had started tysabri over the past 7 months who is still on. There are others who don't respond well to it and have had to stop. I've been the lucky one who only has an infusion reaction almost every time. But an hour or two later i'm fine.

overall, Tysabri has helped me get my life back. I hope it doesn't get pulled.

To sr5599: The xifaxan helps me a ton. it always did. I still take it an hour before eating or knowing that i have a big work-related business meeting. It is almost impossible to OD on it. Trust me... i've talked to the drug company AND I've tried. but between the xifaxan and the tysabri, i'm off of prednisone. that's good enough for me!

J

LavenderBlue
Regular Member


Date Joined Oct 2005
Total Posts : 168
   Posted 8/14/2008 9:04 PM (GMT -7)   
Okay, I must be way behind. Can someone tell me if Tysabri is out public now for Crohn's, or still in trials? I'm not a clinical trial wiz so i don't know a lot of the steps and processes.

Thanks!
lavender
 
diagnosed: Crohn's Aug 2005
 
other set-backs: Vasculitis Aug 2006, Sub-total Colectomy (10 inches of colon left) Feb 2007, Ogilivie's Syndrome Mar 2007, Pulmonary Embolism Sept 2007, Collapsed lung Oct 2007, Recto/Vaginal fistula Nov 2007
 
drugs: Imuran, Remicade, Prednisone, Fentanyl, Warfarin, Flagyl, Cipro, Celexa, Ferrous Gluconate, Acidopholous


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 8/14/2008 11:20 PM (GMT -7)   
Tysabri was approved in January 08 for Crohn's but it took a while to get into action in the infusion labs. I got my first infusion 3/27, 2 1/2 months after it was infused! (I was waiting!)
 
Jid - thanks for the feedback on Xifaxan.  I was going to wait until next week to add it back and see what happens...  I also feel like I finally have my life back, so if Tysabri is part of that, it's likely worth the risk.  But, it's scary.  Sure there are nearly 40,000 (though I read 30,000), but not nearly that many have been on for 2 years.  The numbers for that are something like 6,600 for 24 months and 14,000 for 18 months.  Since everyone is dx with the pml (all but the one at 14 mo) over 18 mo, it's still about the 1/1000 risk.  I am leaning toward turning off my worry mode until the year marker...


--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--methylpred - finally off 6/15/08, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08
--single mom to 10-yr-old girl

Post Edited (sr5599) : 8/15/2008 12:24:22 AM (GMT-6)


hspenser
Veteran Member


Date Joined Dec 2005
Total Posts : 544
   Posted 8/15/2008 4:44 AM (GMT -7)   

sr5599...not being critical, but hoping instead to give you a little relief....if over 14,000 are at the 18 month plus mark...then the ratio is closer to 1 in 2,000.  As far as I know there have 6 instances...maybe 7....so hopefully that helps a little.

I was told by the Bio-gen folks and by the doctor's office that ran my trials that there was no information about being at higher risk for the PML if I started taking Tysabri for the second time.  They did, however, both agree that I could have built up a slight to moderate resistance to the drug.  that my body may have developed anti-bodies that would cut back its effectiveness.  Thus my real quandry is do I go back on with the same or higher risks for the PML knowing that I may not receive all of the benefits I did before.

BTW.....I never had any infusion reactions and I had immediate positive results to the drug.  I did not take anything other than Asacol while on the Tysabri...no anti-b's....no suppositories....nothing.  I feel I had 85 to 95% remission overall and some weeks 100%.  Since the Tysabri is not a cure of the disease but rather a great controling agent of the disease and its symptoms I feel that the drug would wear off near the 28th day post infusion.  I could really tell just by how I felt when it was time for another infusion.


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


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 8/15/2008 12:05 PM (GMT -7)   
Thanks hspencer. As I was typing I guess I thought it didn't make sense, but it was late for me! ;-) Better odds are better odds! Always good news all kept in perspective. At least they're not pulling the drug. We can make our own choices about whether it's worth the risk.
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--methylpred - finally off 6/15/08, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08
--single mom to 10-yr-old girl

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