Grammie 2 3, plenary means comprehensive.....including all or everything....on a subject. I hope that helps a bit

Just scientific lingo for a big meeting to discuss. The good news is that the scientists are discussing the risk factor information compiled to date from the PML cases and appear to have two possible areas for testing - CD4 numbers and iATP. The key to these discussions is to test the ideas for scientific robustness so they don't end up with a test that's actually a red herring (produces false positives or doesn't identify those at risk).

I e-mailed the NIH (Dr Major's ofice (NEJM commentary) to ask about his 12 PML case article verus the Dow Jones 13 PML case article - Is Dow Jones incorrect? Will post what I find out.

Chris

Shayna, thank you
Chris you have now, along with Riverwild, become my hero !! I so appreciate how informed you are and how you try to keep us informed
Thank you
Linda

Reiterated no changes to the label.

More on the FDA Update:

http://www.fda.gov/Drugs/DrugSafety/.../ucm107198.htm

The 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. Of these, four cases were patients in the United States (U.S.). 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.
The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of Tysabri.
The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients. 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.
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. All patients receiving Tysabri therapy in the U.S. must be enrolled in the TOUCH Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections.

Good link to save to favorites. Previous updates are listed here too.

I wonder why no one being treated for Crohns disease has gotten PML. Maybe the numbers are just lower in terms of total taking drug? I see my neurologist tomorrow. I have plenty of questions to ask about Ty and PML. I'll let you know what I find out. I'm curious to know what she thinks of the CCSVI theory. Enjoy the day!

RW: Thanks for the extremely useful information. I guess the aren't willing to or can't speculate on the risk above 24 months? What do you think?

I know of one Crohn's patient from Belgian that got PML while on Tysabri and unfortunately died.

He had been involved in the Tysabri clinical trials with Crohn's but was on the placebo. Months later, he was given the actual drug and within 6 infusions, became very sick and died quickly. His initial cause of death was attributed to a brain tumour but subsequent investigation changed that to PML.

Biogen stated that he got PML because he had taken two different kinds of immusuppressants prior to using Tysabri but his family stated that those drugs had been stopped 8 months earlier and the patient was in good health other than from the symptoms of Crohn's.

I'm not sure if there is any other recorded incident of PML with Crohn's patients using Tysabri since that time.

Harry

Harry, that case I am aware of. I should have been more specific and noted I was asking about cases that occured post clinical trials. I just assumed from the content of the article it was clear what we were talking about. Thanks anyway.

Sorry so late to answer this! I've been working...

I think that I heard that Elan dismissed their Crohn's sales team. I do know that a lot of the gastro docs/rheumatologists are as conservative as a lot of neuros are.

In addition, many docs move to stronger drugs and a lot of those drugs may be contraindicated before Tysabri. They may feel the risk is not worth it when it comes to prescribing Tysabri. We may see more Tysabri use sooner (before stronger drugs used for Crohn's are used) as younger docs come up through the ranks.

I also think that as with any new drug, a lot of docs wait to see what happens with others using the new drugs before they prescribe.

I don't hear much news on Crohns disease and use of Tysabri, but I am not usually looking for it either. I am sure that it's out there, maybe they aren't as vocal as we are?

As far as the speculation on the risk above 24 months use, I believe they use data from studies being conducted on people who are enrolled in the STRATA and the TYGRIS trials, which follows people on Tysabri for MS. I didn't join the STRATA or TYGRIS trials because it wasn't offered to me, I think it had to do with where you go for treatment and I am in a very rural area without the researchers available, and there were certain requirements that had to be met to be in the trials.

Hope everyone is doing well!
I am as usual-working too much and trying to get ready for winter before it gets here to Maine!

I had my first Tysabri infusion yesterday with no side effects, except that I did get a slight headache and upset stomach yesterday evening. Seltzer and Tylenol did the trick.

I signed up for the TYGRIS study.

This is so exciting! I am thinking many positive thoughts!