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Trial drug offer sounds really risky

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Ulcerative Colitis
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Posted 3/1/2013 5:20 AM (GMT 0)
I was late so the GI doc who refused iron infusion when I said my sky high platelet count would soon result in a clot somewhere refused to see me. I got a clot in my ulner artery soon afterwards.

Would have been awkward because if he also said no to UCERIS today I would have had to move on to a new doc.

However I was able to see and talk to a gal about a trial drug that sounded good until I read the details.

"This drug xxxxxxx is similar to drug name_removed where 75 patients who received name_removed developed a rare fequently fatal viral disease of the brain called Progressive Multifocal Leukoenephalopathy (PML).

We believe xxxxxxx is different from name_removed and therefore should not cause this disease but in order to protect your health we will be performing a series of tests of brain function each month that you remain in the study.

?????? Is this how the average trial drug risk section reads ?

This is getting too crazy - thinking about talking to a new outfit.
Posted 3/1/2013 6:20 AM (GMT 0)
Never actually seen one before but im assuming they all have one scary thing or another written on them.
Posted 3/1/2013 1:53 PM (GMT 0)
I personally would say, umm no- my brain is already messed up, I dont need anymore help, I like my brain the way it is. Thank you very much.

Carlie
Posted 3/1/2013 2:00 PM (GMT 0)
Yeah, I guess you're talking about Stelara? Supposedly the same as Tysabri without the PML cases? From what I have read though, this new drug Stelara is at a point in the development process where, when Tysabri was at a similar testing phase, it was not showing as a cause of PML by that early stage either.

That sentence was horribly constucted hope it makes sense.

Edit: I think the similar, derived drug is vedolizumab not stelara, but I'm not sure.

 

Posted 3/1/2013 2:11 PM (GMT 0)
Yes pretty much you got the existing one correct.

Now it says Tysabri would block white blood cells from entering tissue ( gall darn everywhere right ) and why xxxxx is different is because it does the same thing but by effecting the colon tissue *only* so the idea is your brain could still recruit wbc help.

Just sounds every bit as bad as that catheter surgery up leg and over for my hand clot. Over the top risks for pete's sake.

Requested help for sky high platelets/anemia to stop a clot ( Denied ) => now out of hospital surgical team wants GI dudes to get me off pred so the procedure is not so life threatening => GI dudes offer trial biologic as 'better mgmt' but cannot enter me onto to trial until surgery is done and we are in wait-n-see anway.

This is already so circular and jacked up my gut tells me to disconnect completely.

Hand improving, "on-fire" back at work solving tough problems per boss but the truth is nearly everyone with this hammer syndrome clot to ulner has to have resection surgery - all I can find is those with no symptoms had some success with non-surgical thinners and procardia. I have full grip stength and no longer pain pins needles numbess but its cold and whiter and capillary refill is not good.
Posted 3/1/2013 3:03 PM (GMT 0)
I am positive it is vedolizumab, its big claim to fame is no PNL, and fewer toxic side effects that other biologics.
Posted 3/1/2013 3:03 PM (GMT 0)
Check out this pdf, Veto on Vedolizumab, it should give credance to your concerns.

http://onlinelibrary.wiley.com/doi/10.1002/ibd.21078/pdf

Posted 3/1/2013 6:11 PM (GMT 0)
Thanks for the feedback, I remain open minded then. Blocking wbc system wide sounds like a bad a idea, but they are saying they reversed the side driving the relationship, they went to the troubled tissue the colon and make it resist the wbc's which are free to travel elsewhere in the body and do good.

Checking the video now.
Posted 3/1/2013 6:22 PM (GMT 0)

DBwithUC said...
I am positive it is vedolizumab, its big claim to fame is no PNL, and fewer toxic side effects that other biologics.

Millemium and phase III

Vedolizumab is a monoclonal antibody being developed by Millennium Pharmaceuticals, Inc


Lets see what phase mine is in..

OK this is PFIZER and it is 28 months long. First 86 days are study drug where 20% get only placebo double blind. If you continue on to the exended open label study everyone gets the real drug is how I read it now.
Posted 3/1/2013 8:49 PM (GMT 0)
Probably vedolizumab.

There is a more recent article here:

www.internalmedicinenews.com/news/conference-news/digestive-disease-week-2012/single-article/vedolizumab-scores-on-safety-efficacy-for-ulcerative-colitis/dc7ee9857e7f6f4b9a47aac0dfe39f36.html

Article said...
At the end of a year of maintenance treatment, patients kept on the more frequent vedolizumab dosage tested, 300 mg delivered intravenously once every 4 weeks, showed a potent efficacy effect, surpassing the placebo group in corticosteroid-free clinical remissions by 31 percentage points (45% vs. 14%). "Nothing else is that good," Dr. Sandborn said in an interview. "Steroid-free remission with a delta over placebo of 30% is very impressive, especially when you factor in that many of the patients had failed anti-TNF treatment.

"We thought that vedolizumab would be safer than systemic immunosuppression, and I think the data are consistent with that. This will be a first-line treatment," Dr. Feagan said.

I would sign up for this trial if I had a chance and wasn't already in remission which I am currently.

Unlike other biologics it blocks inflammation messengers in the gut only and doesn't shut down your entire immune system, leaving you vulnerable to infections.
Posted 3/1/2013 11:03 PM (GMT 0)
I tried to get into the vedolizumab trial but could not. I would definitely be a-ok w/ this one.

I have a friend w/ MS that was unable to start tsybari b/c she tested positive for the JC virus.

I'm not messing w/ brain stuff. However everything I have read vedolizumab does not have that risk.
Posted 3/2/2013 6:08 AM (GMT 0)
Thank you that really puts a whole different spin on it. I will research as if I am seriously considering doing it. This means i probably need to get the hand surgery out of the way too once off pred.
Posted 3/2/2013 6:40 AM (GMT 0)
i was on vedolizumab and it didnt work for me
i know about 5 more people that was on vedolizumab and it didnt work for them either
Posted 3/2/2013 10:38 AM (GMT 0)
I've read the 45% remission study and it does sound good, especially since those were probably 'worst of the worst patients'. But still, with it's close derivation from tysabri, it gives me pause

Pink1 I think there have been a not insignificant number of PML cases in JC virus negative testers.

There is a huge thread at thisms.com that keeps up with all the tysabri stats. I started to say they might have some vedo information, but I guess since vedo is a 'colon only' acting drug it wouldn't be in MS testing though.
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