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Monday, March 15, 2010

A study, much needed for determining long term usage of Tysabri®

IN Stuart's own words, "I believe the purpose of this study is to see if stopping the use of Tysabri and then the re-start is to determine if for example - if a patient has had 24 infusions and then is taken off Tysabri for 6 months, when they re-begin using Tysabri, are they re-beginning with infusion #25 or is their system re-booted causing them to now begin again with infusion #1.
A study much needed for determining long term usage of the medication".





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2 comments:

Lauren said...

Hi Stuart,

The purpose of this study is threefold..., please see my comment left on your other entry regarding Tysabri:

The main purpose of this study is to find out the following, when participants stop taking natalizumab [Tysabri] for 24 weeks:

* how quickly the effects that natalizumab has on the immune system disappear,

* when MS symptoms return, and

* if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.

This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.

See: http://www.clinicaltrials.gov/ct2/show/NCT01071083

You also have to remember that the Tysabri label indicates at the bottom of page 6 & the top of page 7 the risk for developing antibodies to Tysabri [as well as hypersensitivity reactions] if the patient stops and starts Tysabri:

"Experience with monoclonal antibodies, including TYSABRI, suggests that patients who
receive therapeutic monoclonal antibodies after an extended period without treatment may be at
higher risk of hypersensitivity reactions than patients who received regularly scheduled
treatment.


Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption.

Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients.

Tysabri label:

http://tinyurl.com/y9tvyas

I just completed my 45th Tysabri infusion last Tuesday, and having been on this medication for more than three years, I have not had one single relapse during that time.

Lauren

Stuart said...

Well Lauren - I am delighted to see you response.. It's a pleasure to see comments left on these pages.

And for others reading this, Lauren wrote in her comment that we should see the comment she left on another Tysabri post, about the Restore Study. Here is the link to that posting: http://wwwmsviewsandrelatednews.blogspot.com/2010/03/tysabri-restore-study-interruption.html
(copy and paste if hyper-link doesn't respond)

Providing YOU with MS news is what I do, and it helps to have others help me. to get this news.

Thanks Lauren