JCV Antibody Test info from Biogen

[0485c10]

These are notes I typed into a word document then copied from my word document of notes to this post. (I unfortunately have MS so it is easier for me to type than write )... and not have to type it more than once.!!!!! So it is copied & pasted it into a thread. It does cause some copy and pasting from MY word document...Links are provided to the transcript at the end. ADA RULES!!!!

Biogen Idec Inc. Q2 2010 Earnings Call Transcript

July 20, 2010 |


MY SUMMARY of Transcript:

• 17 patients who developed PML where blood samples were available before they had PML tested positive for the JCV anti body.

• The samples were collected 16-180 months before PML. If the JCV antibody was not important in the risk for PML, then some would be negative for the JCV antibodies. Since all were positive, it strongly suggests that having JCV antibodies would be a risk factor to getting PML.

• Samples were obtained in the US from those people in the TOUCH program & in European in the equivalent program TYGARIS program prior to PML while using Tysabri.

• If the assumption is made that PML is exclusively or mainly acquired by people who test positive fore JCV antibodies, then those that test negative could use Tysabri with less concern of PML. A Stratisfy-2 study was started in the US to test for JCV antibodies. By the end of the quarter 700 people had enrolled in the study, in 90 sites in the US... 8,000 – 24,000 are proposed to have been tested when the trial is done.

• The Stratisfy-1 study established that about 50% of people are positive & 50% are negative for the JCV antibodies.. It is currently estimated that the anti body test has a 2.5% false negative

• A Goal of the study is to identify those who may be at risk for PML and those who are not at risk .Those not at risk can use Tysabri with less concern of the risk.

• Results of Stratify-1 will be release in October of this year at the ECTRIM meeting..

• Biogen has concluded that the risk of PML does increase with prior use of an immune suppressant—(my note:Novatrone, cellcept, cytoxin are some immune suppressants for MS). The increased risk after use of an immune suppressant appears to independent of length of time the immune suppressant had been used. The label has been updated to warn against prior use of an immune suppressant. Wash out period after immune suppressant use & starting Tysabri does not seem as important, there were a broad range of wash out times after an immune suppressant in people who got PML. so no ties appeared to have been determined for washout time after using an immune suppressant.

• Only 13% of patients in the US have been on an immune suuppressant prior to Tysabri use, while its up to 24% for outside the US.(my note: that may explain why there has been more PML in Europe, than in the US. But The US is catching up as people are on Tysabri for longer periods of time.)

• There was a disproportionate amount of people who got PML, who had been on an immune suppressant in the past, making it seem to be a likely contributer to PML.

Transcripts of meeting of meeting: http://seekingalpha.com/article/2154...all-transcript

gov trials

Stratify-2 Trial Study

http://clinicaltrials.gov/ct2/show/N...Tysabri&rank=1

Stratify 1 Trial Study
http://clinicaltrials.gov/ct2/show/N...Tysabri&rank=3

[mibishe]

#2 7/20/10

so i had my second infusion last friday. infusion was started @ 1325 and @ 1340 i started itching intensly. they stopped the infusion gave me a bolus of fluids and an additional 25mg of benadryl IV.

they gave me the option of not completing the infusion or trying again, i tried and was able to complete the infusion

so here's the deal...the only parts of my body with this insane itching were the parts affected by the ms.
right arm and hand, right leg knee to toes, crotch and lower back theses areas are my PROBLEM AREAS. i mean the itching was very intense no rash or hives developed.

i do have an appt. with my neuro guy, can't get my next infision til i see him and will discuss this with him, but i am curious if anyone has any thoughts as to why these were the only areas affected.

i have been much weaker and slower thinking and feverish feeling since this infusion and my balance is horrible when i try to stand, this did not happen after my first infusion.

i apologize for rambling, but would appreciate any thoughts on this I KNOW THAT THERE IS A LOGICAL/MEDICAL REASON.

[LL60]

I don't know what to tell you, but I can just say that the 5 years I was on the Copaxone I got terrible itching in my left arm, which is the arm I sometimes lose the ability in with my MS. Got itching no other place. It was horrible and would last for days. Benadrly didn't even seem to help. I finally just stopped giving myself shots in the left arm.

I'd be interested in seeing what your doctor says. If it was just a problem of itching, seems like the extra Benadrly did the trick, but since you are having other issures after this one, it is either just a fluke thing, or a relaspe or something else maybe with the Tysabri. You can always call them too and see what they say. I find who answers the phone just seems to read from a "cheat sheet", but they know the general information about side effects and things like that.