pml versus dose/month of Ty

[0485c10]

i have too much time on my hands, as i am shortly to prove by this post.

i entered the pml cases reported on this site,to an excel spread sheet so i could sort them.
http://chefarztfrau.de/?page_id=716

i'm kind of glad i did. i'm at 30 infusions i had read the high risk period was at 24 infusion but it seemed to go down after 30 infusion. i thought to myself great! i'm now past the high risk time and i seemed to have gotten through the high risk time unscathed by pml.

but i sorted that data on that site and the highest risk is after the 34 dose/month. the second highest risk is after 24 &44 dose/month...so not quite yet clear sailing for me yet. 2 more high risk doses for me to ge through but i did get through one high risk unscathed.

i'll list what i got, because i am certain there are others who are curious about this.

i'll list it from highest to lowest incidents. # of pml(# of dose/month, #of dose/month)

so 4(25,35,40,46,49,52) means there were 4 pml cases that happened after 25 dose/month & 4 pml cases occured after the 35 dose/month & 4 pml cases occurred after 40 dose/month,....ect.

i use dose/month so you will be aware that it is not exactly ? doses or ? months. the data has been reported either by dose or month. if a 4 week ty schedule is used 12 months will have 13 doses & some ty users will dose every 3 weeks or 6 weeks. some will skip a dose because of surgery ect. these were reported in either dose or month and i sorted them together.

here what i got. the highest risk is after 34 dose/month with 6 pml cases happening after 34 dose/month. so 24 isn't a time the risk is highest & then it gets lower, always be alert for pml symptoms. its still new & this is not that much data collected yet to make any conclusions like this.

hopefully with the jcv antibody test & people not using ty after an immune suppresent has been used these # will go down.

6(34)
5(24,44)
4(25,37,40,46,49,52)
3(30,31,33,35,38,41,45)
2(14,17,20,29,50,53)
1(12,13,21,22,27,28,32,36,39,42,43,51,55,56,57,59)

6*1=6(1 pml after 34 infusions)
5 *2=10(5 pml after 24 infusions + 5 pml after 44 infusions=10 pml)
4*6=24 pml
3*8 =24 pml
2*6=12 pml
1*17=17 pml

added together 93 pml cases at time of this post.

[Cate Power]

You wrote, "hopefully with the jcv antibody test & people not using ty after an immune suppresent has been used these # will go down."

In your research, have you seen anything about people who were on immune suppresents, stopped, and then took Tsybri? A neuro at UMD MS Center said he'd give it a go, if I could get "clean" of a daily steroid for a month (and forever thereafter).

[Redwings]

Hi Cate:
I don't have the stats with me right now, but a remarkable bit of the history of some of the people who developed PML is that they had been off of other immunosuppressant meds for months to years before starting Tysabri. The common factor in many of the PML cases is that they had been on immunosuppresants at some time before Tysabri vs. those people who hadn't been on immunsuppressants at all.

It isn't just the daily prednisone that makes you an unsuitable candidate for Tysabri. It would be that you have a history of other immunosuppressant meds, even if you've already been off of them for a few years. Knowing that, your neuro -- and you -- would be going against the current wisdom that strongly advises against Tysabri for you.

[0485c10]

You wrote, "hopefully with the jcv antibody test & people not using ty after an immune suppresent has been used these # will go down."

In your research, have you seen anything about people who were on immune suppresents, stopped, and then took Tsybri? A neuro at UMD MS Center said he'd give it a go, if I could get "clean" of a daily steroid for a month (and forever thereafter).

i read an article in best practice for selecting patiants for treatment with tysabri---a year ago, but tysabri research is moving so fast that is already old.

at the time there was a strong suspicion that past use of an immune suppresent was a big risk factor for pml. it seems there has been greater certainty that it is a risk factor since.

in that article it advised that tysabri was not totally contra indicated if a person had used an immune suppresant in the past--it dependent upon how long the person had used an immune suppressant in the past & if it was a direct switch from an imune suppresant to tysabri like a 3-6? month dry out period be used between the meds.......

i think the immune suppressant before tysabri is used is a part of the transition of a new med being introduced. many people had to go to an immune supperassant first because tysavri was not available and the option was an immune suppressant. now many people are given a choice between tysabri or an immunsupprresant when the standard drugs get ineffective. they go with tysabri first & then an immune suppressant. so there will be less & less people using tysabri that had used an immune suppressant in the past.

the recommended washout periods from that article:
interferon 1b & glutimer acitate- no specific washout period
pulse dose ivmp steroid-no specific wash out period

oral immune suppressant - 3 month washout period
iv immune suppressant-6 month or longer washout period a longer washout period should be considered if the person has recieved extended treatment with any immune suppressant therapy.

patients treated with long lasting immune suppressants like alemtuzumab,cladribine, novatrone, mitoxantrone a year or longer.

as new immune supressive therapies become available for rrms it will be important to determine the sequence these therapies are used at that time.

Laboratory tests that should be done before considering Ty use.. a complete blood count, absolute lymphocyte
count, CD4+ count, and liver function tests with a
hepatic profile. Mild to moderate elevations in liver
enzymes do not contra indicate ty but should trigger further evaluation in addition hiv seriology should be considered depending upon the patients demographic and risk fot hiv.

in that best practice article ( which would be old now, in new med years)

[LL60]

Is prednisone an immunesurpressant? I am on 60mg of prednisone right now for an ear problem. Will be on it for 7 days and then taper off. I have an infusion next Friday. My doctor is on vacation and the on call guy said to put off the infusion for 2 weeks. I already have a sub for next week. That is a very hard thing me to get and make arrangements at work. And then I would have to change the next 6 months of infuions. I told them to wait until my doctor gets back next week and ask her.

Have any of you ever had prednisone while getting an infusion? I will be down to 30 mg by next week.

None of the neuro at my insurance group are MS doctors they all are just general neuros.

[0485c10]

I don't know. I had a 5 day course of ivsm between infusion & i took my last taper dose of prednisone the morning of my next infusion...so i did not have experience with prednisone during the infusion, just between.

waiting for your doc sounds like a good idea & also have you thought about calling tysabri bigen nurse and asking if its okay to be taking prednisone while being infused.

before i started taking st johns wort, i called tysabri to askl if it was ok. i thought it was ok but just to be certain i called.

she said i should tell my doc and not much else..my appointment is 2 months away....so i thought if it was absolutrely not allowed she would have said that..but a check withg your doc didn't sound absolute--so i just told my ty nurse before the infusion & plan to tell the doc early next month at my normal appointment.

didn't have experience with taking prednisone while being infused. so i don't know.

[0485c10]

I. That is a very hard thing me to get and make arrangements at work. And then I would have to change the next 6 months of infuions. I told them to wait until my doctor gets back next week and ask her.
.

have you thought about just skipping this infusion to stsy on schedule? people have to do that when they have surgeries and such---but talk to your doc first i think its ok if prednisone is being used during a tysabri infusion---but if not could you just skip one infusion then stay on schedule. he said delay it be 2 weeks,thats half whole 4 weeks anyway.

[LL60]

Wow, great suggestion. A good compromise maybe. I went 5 weeks once due to something, can't remember now. I really was ready for it by then, but I had only been on about a year. This will be #22, so maybe I wouldn't feel that this time.

I have planned a vacation around the infusions in May. Not so easy to change things with that.

I will try to talk her into letting me do the one next Friday, but I will bring that up to her too.

I tried calling Biogen. They were no help. "Ask your doctor" was all they said.

I read where SSHL can be related to MS. Anyone else ever get that?

[Cate Power]

No Prednisone while on or considering Tysabri--it disqualifies from taking under the TOUCH criteria. I can't even get the darned titrate blood test to see if I would be excluded anyway. You folks who can take are very fortunte. Holding the beast at bay is a personal goal and obsession I pray I may achieve.

[ru4cats]

US versus worldwide PML risk

0485c10
Would you consider redoing your graph using just US cases of PML? I ask this because the TOUCH protocol was introduced to monitor for PML and there have been 38 cases to date of PML in the US. I have to believe we have most of the users of Tysabri, so I'm wondering if this wouldn't lower the risk in the US.

[0485c10]

0485c10
Would you consider redoing your graph using just US cases of PML? I ask this because the TOUCH protocol was introduced to monitor for PML and there have been 38 cases to date of PML in the US. I have to believe we have most of the users of Tysabri, so I'm wondering if this wouldn't lower the risk in the US.

I did that ru4cats...38/93 where in the us.

the pml cases happened the most after the 34 &
44 infusions, 3 pml cases happened then.

3(34,44)
2(20,33,38,46,52)
1(14,24,25,26,29,30,35,37,39,40,41,42,48,49,51,53,5 5,56,57,
57,59)

[0485c10]

0485c10
Would you consider redoing your graph using just US cases of PML? I ask this because the TOUCH protocol was introduced to monitor for PML and there have been 38 cases to date of PML in the US. I have to believe we have most of the users of Tysabri, so I'm wondering if this wouldn't lower the risk in the US.

above i posted the # in the us --i submitted it, it hasn't been posted to the board yet. i had difficulties with my pc so i wassn't able to post the rest..if the us cases got lost when my computer hung up i will repost that.

i addition to the us cases i went through the us/others by months which as been increasing since 2008...

1/0 =1 case in us & 0 in other. 0/1 = 0 in us & 1 in other.
3/8 = 3 in us, 8 in other total of 11.

2008(0/2,0/0,0/0,1/0,0/0,0/1)
2009(0/0,0/1,0/0,0/1,1/0,0/3,1/0,0/1,2/3,3/4,2/2,0/2)
2010(1/2,2/4,2/4,1/0,2/3,1/3,3/2,3/0,2/3,2/0,2/3,2/4)
2011(3/8)

oh what the heck i will retype what i submmitted.

the highest pml instance for the us was after the 34 & 44 infusion.

3 pml cases in us (34 & 44 infusions)
2 pml cases in us (20,33,38,46, & 52 infusions)
1 pml cases in us(14,24,25,26,29,30,35,37,39,40,41,42,48,49,51,53 ,55...
56,57, & 59 infusions).

[ru4cats]

0485C10

Thanks! Checked out your website, too. Great info!

[lindaincolorado]

I've been watching this site since Biogen closed down their site about 1 1/2 years ago. I have wondered about a couple of the infusion numbers from the U.S. The first one of the 52 infusions was in 2009, since Ty was re-introduced 7/2006 that one is either from the trials or was taking more that every 4 weeks. The other is #59-same scenario...

I started Ty 20/2006 since, for over a year I do not get them on the 4 week schedule I am at (I think #53 this month - if I had infusions every 4 weeks I would be at #57.

I keep trying to find out how many Ty users there are at the 4 year mark to no avail. Biogen keeps telling me there is no way to know this-I think they are full of it because they know all due to the Touch program. Very frustrating...

[0485c10]

I keep trying to find out how many Ty users there are at the 4 year mark to no avail. Biogen keeps telling me there is no way to know this-I think they are full of it because they know all due to the Touch program. Very frustrating...

that must be very frustrating, i just got frustrated when they stopped that site where they disclosed the pml cases--what you have to go through, knowing dam well that they know but are not sharing the info even with the small group of people in that situation must make you terribly angry.

it would be better if the person at the end of the phone line said they are not authorized to release that information or they themself do not have access to that information---instead of saying its not known..yeah right, that gives me much confidence in this company if they don't know how long people have used their med..Grrr!

did you try writing a letter, then getting their refusal to release that information in writing?

even in writing i think they will still refuse because the pharma industry is so competitive--but going through the excersize may give you an opportunity to vent some spleen. might make you feel better for the cost of a postage stamp.