This Is MS Multiple Sclerosis Community: Knowledge & Support

Welcome to the world's leading forum on Multiple Sclerosis research, support, and knowledge. For over 10 years, This is MS has provided an unbiased community dedicated to Multiple Sclerosis patients, caregivers, and affected loved ones.
It is currently Sun May 19, 2013 4:02 pm

View unanswered posts | View active topics


Board index » Treatments » Chronic Cerebrospinal Venous Insufficiency (CCSVI)

All times are UTC - 8 hours [ DST ]



Post new topic Reply to topic  Page 1 of 1
  [ 6 posts ] 
  Print view Previous topic | Next topic 
Author Message
cheerleader
PostPosted: Tue Sep 22, 2009 9:43 am 
Offline
Family Elder
User avatar

Joined: Mon Sep 10, 2007 3:00 pm
Posts: 4676
Location: southern California
New warning from out this week from the FDA- PML seems to be a growing complication in only MS patients. But is not a concern in Crohns. If we consider PML within the CCSVI paradigm, we can see how slowed venous return and blood deposition into brain tissue could allow for a virus like PML to attack the brain. Shouldn't the docs be asking "Why no PML in other patients using Tysabri? Why is it only in MS?" If the immune system is the immune system thruout the body- what possible reason could there be that PML is only affecting MS patients???


Quote:
Natalizumab (marketed as Tysabri)
Audience: Neurological healthcare professionals, patients
[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
The risk for developing PML appears to increase with the number of Tysabri infusions received. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.
[09/16/2009 - Information For Healthcare Professionals - FDA]

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS


Top
 Profile  
 
Loobie
 Post subject:
PostPosted: Tue Sep 22, 2009 10:12 am 
Offline
Family Elder
User avatar

Joined: Mon Sep 11, 2006 3:00 pm
Posts: 2197
Location: Dayton, Ohio USA
8O 8O Whoa. Hope I'm in the clear. I never liked those stats, and liked even less that Biogen quit reporting. It's been 14 weeks now since my last infusion, so hopefully it's washed out.

_________________
http://myhopefuljourneyintoactualmsreco ... ogspot.com
Top
 Profile  
 
radeck
 Post subject:
PostPosted: Tue Sep 22, 2009 10:41 am 
Offline
Family Elder

Joined: Mon Feb 16, 2009 4:00 pm
Posts: 398
Could it be that Tysabri hasn't been given to enough patients with Crohn's to make the claim that it doesn't affect them? The citation mentions that only 2% of all patients treated with Tysabri in the US get it for Crohn's. The risk of getting PML in MS patients is 0.1%. I'm guessing that the number of Crohn's patients getting it is in the tens...It has to be 1000 on average before a single case with PML will occurr.

I agree with the principle that a person with slowed brain perfusion should be more likely to get PML, however are we able to tell from these data?
Top
 Profile  
 
Anecdote
 Post subject:
PostPosted: Tue Sep 22, 2009 11:05 am 
Offline
Family Elder

Joined: Thu Jun 17, 2004 3:00 pm
Posts: 2012
Location: Bedfordshire UK
Best read this page: http://www.ninds.nih.gov/disorders/pml/pml.htm

PML is most common among people with AIDS and also in people with Hodgkin's disease, lymphoma or even sarcoidosis. Do they have stenoses in their jugular veins? Because of their lowered immune defences, they can't fight the virus which causes PML, which most people carry without it causing any damage. Lew has no need to worry.

Sarah

_________________
An Itinerary in Light and Shadow Completed Dr Charles Stratton / Dr David Wheldon abx regime for aggressive secondary progressive MS in June 2007, after four years. Still improving with no relapses since starting. Can't run but can paint all day.
Top
 Profile  
 
cheerleader
 Post subject:
PostPosted: Tue Sep 22, 2009 11:09 am 
Offline
Family Elder
User avatar

Joined: Mon Sep 10, 2007 3:00 pm
Posts: 4676
Location: southern California
your right, Radeck. The numbers aren't there.

And Lew, I wasn't putting this up to freak you out...seriously! We may learn in the future that what you did prior to stenting with tysabri was the right thing to do! I've talked to Dr. Cooke and Marie about this, and someday there will be a perfect protocol involving immune intervention, stenting and follow up care. We don't have it yet. In any event, now that your perfusion time and mean transit time have improved with better venous flow, I'm sure there are no worries.

I'm really more commenting on the fact that I haven't seen any medical research as to WHY PML occurs in MS brains. What's the mechanism of action? Why the brain? That's all.
Just saw Sarah's post...thanks for the clarification! It's just immune- as seen in HIV...nevermind!
cheer

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS


Top
 Profile  
 
mrhodes40
 Post subject:
PostPosted: Tue Sep 22, 2009 11:12 am 
Offline
Family Elder
User avatar

Joined: Thu Sep 23, 2004 3:00 pm
Posts: 2066
Location: USA
Good thought Rad,
TYSABRI STATS FROM PROSPECTUs

it appears there may be 100,000 on tysabri....in Aug of 08 it was already 32,000.

considerably more than a few crohn's patients then...... enough that one or two "should" have had PML if at the same rate as MS....still statistically really small

_________________
I'm not offering medical advice, I am just a patient too! Talk to your doctor about what is best for you...
http://www.thisisms.com/ftopic-7318-0.html This is my regimen thread
http://www.ccsvibook.com Read my book published by McFarland Health topics


Top
 Profile  
 
Display posts from previous:  Sort by  
Post new topic Reply to topic  Page 1 of 1
  [ 6 posts ] 

Board index » Treatments » Chronic Cerebrospinal Venous Insufficiency (CCSVI)

All times are UTC - 8 hours [ DST ]

Related topics
 Topics   Author   Replies   Views   Last post 
There are no new unread posts for this topic. has anybody ever thought of this?

[ Go to pageGo to page: 1, 2 ]

Filmmaker

25

2731

Sat Apr 02, 2011 4:13 am

Johnson View the latest post

There are no new unread posts for this topic. The thought of it grosses me out

[ Go to pageGo to page: 1, 2 ]

DenverCO

28

3421

Sat Jan 08, 2011 2:50 pm

pklittle View the latest post

There are no new unread posts for this topic. barometric pressure may be doing a lot more than we thought

blossom

10

1220

Sat Mar 16, 2013 8:53 pm

positive View the latest post

There are no new unread posts for this topic. A thought about drug trials and CCSVI

LR1234

6

1088

Thu May 27, 2010 6:16 am

LR1234 View the latest post

There are no new unread posts for this topic. And you thought Montel didn't know Jack..

CureIous

14

1068

Thu Aug 30, 2012 4:04 pm

EJC View the latest post

 


Who is online

Users browsing this forum: No registered users

You cannot post new topics in this forum
You cannot reply to topics in this forum
You cannot edit your posts in this forum
You cannot delete your posts in this forum

Search for:
Jump to: