#36 down. No problems, no concerns as usual.

Had the meeting with my neuro after the infusion. He went to the Key Opinion Leaders Conference last month in FL. He had a lot to say, even had notes. We talked for over an hour. He is no longer pushing drug holiday. His opinion is that there is no protocol, no studies to back up a holiday although there is talk of setting up some sort of scientific study, and that the assay will be out within months and that once you are identified as a non-carrier of JC virus, you'll stilll have to be tested every 6 months since we don't know when we are exposed, who becomes a carrier once they are exposed, etc, etc, etc. Regardless, it was a relief for me since I didn't want a holiday.

So I wait for the test/assay to come out, get on the trial if one is required to test the assay and we shall see where it goes from there!
Life is good!

You can't blame it on me. All of us post articles for each other (those people TAKING Tysabri or considering it). It's very easy for you to copy the link to the Lancet article, repost it in the general MS forum, and start your discussion there.

Thanks RW!! And congrats on #36 :yahoo: I would be curious to know if you learned anything more about the assay. Is it still unclear whether this will be available to all people on Tysabri OR only people who sign up for the clinical trial? My neuro isn't keen on drug holidays either because of the danger of developing antibodies to Tysabri.

According to the notes he gave me, the assay is pretty specific and can pick up as few as 25 copies? of the DNA of JCV in a sample. He wasn't clear on who would be tested but is going to find out more info, but he believed that it was mentioned that it would be trialed and that it had been used on the blood samples from people who were in one or another of the trials (STRATA or TYGRIS) who developed PML and that in every case, they had tested positive for JC (unfortunately, it was after PML). I told him if it did require a trial, I wanted in on it.

He was much more positive this time around. I think being able to talk to others with more people on long term therapy with Tysabri made him a little more comfortable in waiting for the assay.

Running on battery here, back later.

Hey FinLady, wishing you my best !

I am a grateful Ty user and have been for almost 43 infusions. I didn't like where I was headed - ms sx. Offered Ty, made my most informed decision and went with it. It has been good for me-MRIs stable even a bit better, no progression Thank G-d and some sx have gotten better (fatigue, eye and balance) my stamina has increased.

For me Tysabri has been a blessing :D

CONGRATS RW!!!

Linda

Amy, thanks for what sounds like good news. I had my first infusion on Feb 18 and felt so odd for the first week, now I feel better. My walking had improved so much after my Dec flare, then then the symptoms suddenly increased the week prior to infusion.

My energy is better now, walking and balance are both a litle better. Maybe this will actually work!

Susan

I got a call today from an "information service" company. They asked if I would be willing to be interviewed by local media outlets and give a patient's perspective on Tysabri. She asked some questions about my experience and my views and told me she would send an email following up to make sure she had my facts and story straight.

Maybe I'll be in the local Mulch Pile! :D

Just want to check in with my Tysabri buddies to let you all know I'm doing great so far on Copaxone. The price has gone way up, over $2,800 per month :eek: but it's working well for me (knock on wood.)

I started a new job and I have to stand all day and sell, :thud: and yes, you read that right. :eek: :D I have new insurance that's very good and I save over $500 a month with that.

Wish me continued luck with the Copaxone and as usual, I'm cheering for you all and keeping you all in my prayers for continued good luck with Tysabri. :grouphug:

Three infusions and they are already pulling the plug. Well, not all of the way. The latest MRI shows some bad stuff (5 new lesions, 2 active in my T-Spine). The C-Spine and Brain MRIs have been postponed again because of insurance and the neuro agreed we need to see whats going on elsewhere before we do another infusion. AND we await the results of the bone density as she does not want me on Ty if I have to go in for surgery.

So, no Ty for me next week. Good luck guys!

I had infusion #30 almost 2 weeks ago. It went well. But, approx 5 days later I developed a fungal infection. I'm using a nystatin cream for it. The darn infection is very persistent :( My neuro isn't concerned but, I'm wondering if anyone else has had a fungal infection after an infusion. I don't know if they are related or not. Even if they are related I won't stop taking my Ty unless they give me a blood test to check for my possibility of developing PML and I test positive. If that happens I'm going to cry...LOL

My main problem actually is that my husband freaks out every time he hears about another PML case :( It has not been confirmed but there have been reports of another PML case yesterday. That would bring the total number of PML cases to 40.

Take care everyone....and have a great day. Spring is going to be here soon...I hope ;)

No official update from Elan/Biogen. Probably in a few days. I will report the official confirmed number as soon as it comes out.

Shayna, thanks for checking in! Spring better be here soon, I can't take much more, it's snowing here right now...:rolleyes:

I skipped one infusion because I had a ruptured appendix. They had three different antibiotics running into me after surgery, the infusion was scheduled for the day I was to be released and I decided to skip it because i was concerned about having so many meds running into my veins.

I came down with a raging yeast infection from front to back down below and a nasty case of thrush. I did diflucan and a nystatin swish and everything cleared up, but it was hell. I was on zofran for vomiting, and oral antibiotics and until I was done with the oral antis, the other stuff stayed.

I don't know what tossing Tysabri into the mix would have done, but I knew I wasn't ready for an infusion. My neuro left the choice up to me, but said it was ok to do the infusion.

I no longer tell the old man about where we are with the PML cases unless he asks.

I've got the same number-40- for PML cases.

RW, I don't tell David anything. He googles PML and Ty regularly :(

More Tysabri news
 

The article is longer than needs to be posted here. Please click on the link to read the full article. :)


http://www.prnewswire.com/news-relea...-85813232.html


WALTHAM, Mass., March 1 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of secondary progressive multiple sclerosis, Biogen Idec/Elan's Tysabri will remain Decision Resources' proprietary clinical gold standard through 2018...

Glad to hear it's going well for you, both the Copaxone AND the new job!

I wonder how companies justify increasing the price of drugs that people need to survive or live a normal life, when the economy is in the freakin' toilet. Shame on them all, they deserve to be beaten with the outrage and despair of every person who has to give up treatment because they cannot afford it. :mad::mad::mad:

What amazes me is they keep issuing patents on these specific drugs making it impossible and illegal for any other company to manufacture a generic version, therefor creating a monopoly in which companies like Biogen Idec can go to the consumers and say pay us $5000 a month or this disease will take you over and you will be physically impared for life! And there is nothing anyone can do about it because they are the only ones who have access to the drugs.

Which of course in turn forced people to become dependant on medicaid and medicare to help cover these expenses. Even when I was working full time, I didn't make $5000 a month. And I sure didn't have an extra 2000-3000 lying around to spend on any of the other DMDs.

Just a update - #23 down 8 days ago and still in a relapse. My neuro is getting stricter. Blood tests more often now and they are having us see the neuro every 6mos and the nurse every 3mos. Last year was nothing like this. I assume it is due to the PML data - not worried about that here. Hope everyone is doing well - wishing you all the best! Bring On Spring!!!!!!!!!!!!!!!!!

Sorry to hear you are still in a relapse, Pink. Did they go through the whole list of MRI, bloodwork, etc?

It's my understanding that if a person appears to be in a relapse, they automatically check for PML, and hope it's a relapse, because relapses are rare if Tysabri is working. I haven't had one since starting.

I have done the quarterly neuro appointment since I started in 2007, the bloodwork every 6 months, and the infusion nurses are on top of it all every month, asking more questions than normal if they suspect anything.
I do go to a VERY small infusion center/oncology center in a 25 bed hospital and they have more time/knowledge of the patient and I think they notice when a patient is "off their game" or outside of their norm.

I started out thinking the whole procedure from beginnning to end with infusion/waiting/observation, etc. was a pain, but now I just do it since I know the team isn't going to let me go any sooner.

Riverwild - sorry to be late. I tend to come and go here fast and missed your post.

It took me two months to convience them I was in a relapse, but yes I have had it all. MRI, blood tests and 5 days of home IV steroids. MRI confirmed an active leasion, but thank goodness no new ones.

This center is of average size - they only did blood work 1X last year - now every 3mos. I also had to sign a pregnancy wavier or be urine tested every time. I've not seen a neuro since I started here (only the nurse). Now they are doing the nurse every 3mos an the neuro every 6. Yes, same here - the nurses ask tons of questions every time. My total time is at 2.5 hours due to all questions. I hate it!

I went to see another neuro, but was not impressed. However, he said that steroids do not cut down on the amount of disability from an attack. He stated they only cut down on the length of the attack. Has anyone heard this? The longer this goes on, the more sx I get, so this would not seem to be true, but unsure. Thanks :hug:

Pink, be careful mixing steroids with Ty. My neuro is under the impression that steroids increase your chances of getting PML while on Ty. I have heard different from other sources, but she heads up the studies being done at the main college here and that was one of them.

And yes, it is true steroids have not been proven to do anything as far as stopping the attack. They simply cut down the inflammation that usually takes place around the active lesions, giving some relief to the symptoms. For some reason, I don't seem to have inflammation with mine so the steroids do nothing but make me sick.

JC-virus antibody assay trials underway
 

From Biogen yesterday at an investor conference

The first of the STRATIFY trials, to validate the JC-virus antibody assay, is now underway. The second trial is about to enrol its first patient.

Just a few things:

#1: Pink, as long as you had the blood tests/MRI etc, your doc appears to be sure it is a relapse, and if it is a relapse, steroids are allowed. It sounds as if they are right on top of what needs to be done as far as tests prior to steroids. I hope they help.

One thing I don't understand is that when I had steroids IV during relapses, I always had the three day course. At NO time did anyone ever prescribe 5 days. Why is the protocol/dose different for everyone?


#2: Avonex is now more expensive than Tysabri. Do you think they are pulling a Cephalon move? Cephalon increased the price of Provigil to try to force people onto Nuvigil, since provigil is going off patent. If they can get people on Nuvigil, they retain the $$. Biogen owns Avonex and owns part of Tysabri. Avonex is going off patent soon and any pharma with biological production capability can start making Avonex. Where do you suppose Biogen wants their patients on Avonex to go?

#3: The assay- The FDA is already in trouble for what's been going on with pills and meds-think Avandia. They are going to be VERY careful before approving anything. Ask yourself why they would require a two year trial of a simple blood test. I understand they may need to find where "statistical significance" is, and that the neurologists will get the results, but do they actually think that any good doctor is not going to disclose results to their patient? The patient will be cautioned about trials and stat sig, but the result will be there, negative or positive.
Speak with your neuro if you want this test. You can find more info on the two trials at:

Stratify 1: http://www.clinicaltrials.gov/ct2/sh...d+assay&rank=1


Stratify 2: http://www.clinicaltrials.gov/ct2/sh...s_ex=Y&rank=41

Everything going well here, hope it's the same for you all!

Biogen extended the Avonex patent out to 2026 so it doesn't have to do with patent extension - just greed. Sad that drug price cost has nothing to do with efficacy/relative efficacy.

The 1000 patient trial is a prospective study to prospectively determine the accuracy of the assay (blood test) relative to JC virus present in urine (PCR testing). They should be able to determine accuracy/market the assay after the initial tests of the 1000 patients. The 2 year timeframe may relate to determining the percentage of patients who go from negative to positive over the two year period.

The 8000 patient trial is being run to show the risk of PML for those who test negative on the assay. Given that you can't develop PML without the JC Virus, logic would say that the risk of PML for those who test negative is negligible but you can't put that in the label without clinical proof.

Can you explain how they can determine the accuracy of the assay after testing 1,000 people? Don't you have to follow the people you test to see if those who test positive for JC virus get PML? Urine, blood, and spinal fluid may not show evidence of JC virus but it could be there, right? That's why we need the assay?

The 1000 patient trial is to determine the accuracy of whether someone is JC Virus antibody positive or not - the blood test JC Virus Antibody assay result will be compared to the JC Virus PCR Test Result from the same patients urine to detemine proper correlation - should be positive or negative on both - otherwise false positive or false negative.

The 800 patient study will determine the rate of PML in patients who test negative for the JC Virus Antibody.

The premise of the JC Virus Antibody Assay is that if you've been exposed to the JC Virus you'll have JC Virus Antibodies in your system. 11 of 11 patients who developed PML and had earlier blood samples stored tested positive for JC Virus Antibodies.

I got another call yesterday. They are doing a "satellite feed" and from what I was told it will be country wide and it's radio stations and television stations doing interviews, so I guess the local "Mulch Pile" paper won't be involved. Both my neurologist and I will be interviewed.

When I know more I'll let you know! Has anyone else been contacted for this?

My husband did his "google alert" for TY and PML. There have now been 42 cases. The last 2 were in the USA. I can't find any other info.

This information is from the Dow Jones Newswire (today).

The total number of patients who died of PML is now 9.

Of the 42 cases so far, 15 have been in the US, 24 have been in the European Union, and 3 have been in other areas.

SURPASS

Biogen and Elan enroll first patient in large well controlled study comparing Tysabri to Copaxone and Betaseron in head to head studies.

http://eon.businesswire.com/portal/s...88&newsLang=en

My neuro told me today, the number of PML cases is 40 or more. One of the main stockholders resigned and sold his shares. :confused: ??? And the current number of patients has not even neared the original projected number. (They consider anyone who tries it even once to be included in that number, even if they no longer take it.)

I'm doing well on Copaxone and will stay on this. I hope all is going well with my friends who are still taking Tysabri (or considering it.)

My checkup today went well and at three months on Copaxone, I'll be sticking with this.

Well, I had infusion #20 on Monday. I am now on the every 8 weeks schedule to minimize UTI's. This infusion was great: no flu like side effects. Sometimes it is really crummy for 2 days afterward and sometimes it is a breeze. Unfortunately, I think I got another UTI that started today. Ugh. So now I have to head back to the urologist.

Last week I finally saw my new neurologist who used to be at Johns Hopkins--basically my MS clinic "stole him away!" I like him MUCH better than the last one who was a dud. We talked about several things. 1. I shouldn't really take a prophylactic antibiotic for a week each time I get an infusion because it may build up resistance to the bacteria and then the only thing that would work would be IV antibiotics. 2. He also questioned whether I should stay on Tysabri--he said it is a little bit of an overkill since I have such mild MS (just the hardly noticeable optic neuritis, a little dizziness and cognitive stuff at that first event). I haven't had a relapse since I was diagnosed 2 1/2 years ago. Now he knows I went on Tysabri because I couldn't tolerate interferons or copaxone and he understands. He also said that we can't know if the Tysabri is what has prevented me from having any more relapses. I told him I was worried about my initial MRI with the black holes. He reminded me though that MRI doesn't necessarily correlate with symptoms. But given the UTI's and the PML risk with such a mild case of MS he suggested switching to something else. It's sad because I love my Tysabri!

He tried to steer me toward Avonex. I had tried Rebif. He thought maybe once a week might be tolerable. Of course I can't stomach that idea!! :( He also said I could take a steroid pill called decadron on the day of the Avonex shot and that pretty much wipes all the side effects out. But again, the thought of taking regular steroids, even if one day a week, does not appeal to me.

We talked about the pills about to come out--cladribine and fingolimod. Out of the two he would lean toward fingolimod. He is very worried about the cancer risk with cladribine, and not just skin cancers, therefore he wouldn't advocate using that. Of course he said both drugs are serious immune suppressors. It's the same old dilemma: the better the benefit the higher the risk of opportunistic infections.

Anyhow, he wasn't pushing aggressively, just noting different options. We decided that I will get two more Tysabri infusions -- in May and in July. We will then meet in July to decide what to do. He will look at MRI results then. He is hoping that fingolimod may be on the market by then and I would switch to that.

Oh, in the meantime I found out I am iron deficient! I have been taking iron supplements for 3 weeks now and I feel like a new person. My hair stopped falling out, my lips are no longer chapped (weird symptom, huh?) AND the best part is I have stopped taking long naps. I have super energy now--I don't feel sleepy or fatigued like I used to. Sometimes at the end of the day I would just collapse with exhaustion. But now I have much more stamina. My brain feels a lot clearer and my memory is better. I am very happy about all of this! I thought maybe the fatigue was the MS or a Tysabri side effect. Really, it's likely I was very anemic.

Anyhow, I don't mean to go on and on and on and on..... :D

There is a new article out that breaks down all of the details of the first 28 patients who got PML while on Tysabri. It is excellent. It tells you things like age of patient, gender, what drugs they took before Tysabri, duration of symptoms before PML was diagnosed, symptoms experienced with PML, whether there were enhancing lesions, duration of first treatment of PML to first symptom of IRIS, symptoms experienced during IRIS, JC viral load in spinal fluid, and status of person at last followup. The article offers many suggestions for trials to be done or further questions to be answered. Interesting facts include 1. 40% of people with PML had enhancing lesions 2. several people had seizures so add that to the list of possible PML symptoms 3. PLEX was used for treatment in all but one case. 4. treatment for IRIS persisted for several months in many cases 5. brain location of lesions is more relevant to prognosis than size of lesions. 6. the survival rate is 71%. 7. 54% received mefloquine and 39% received mirtazapine as adjunctive treatment along with PLEX and steroids. 8. 3 out of the 28 were treatment naive before Tysabri 9. 7 out of the 8 deaths were in the USA

"Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases," The Lancet Neurology, Volume 9, Issue 4, Pages 425 - 437, April 2010

Here is the abstract:

Background Treatment of multiple sclerosis with natalizumab is complicated by rare occurrence of progressive
multifocal leukoencephalopathy (PML). Between July, 2006, and November, 2009, there were 28 cases of confi rmed
PML in patients with multiple sclerosis treated with natalizumab. Assessment of these clinical cases will help to
inform future therapeutic judgments and improve the outcomes for patients.
Recent developments The risk of PML increases with duration of exposure to natalizumab over the fi rst 3 years of
treatment. No new cases occurred during the fi rst two years of natalizumab marketing but, by the end of November,
2009, 28 cases had been confi rmed, of which eight were fatal. The median treatment duration to onset of symptoms
was 25 months (range 6–80 months). The presenting symptoms most commonly included changes in cognition,
personality, and motor performance, but several cases had seizures as the fi rst clinical event. Although PML has
developed in patients without any previous use of disease-modifying therapies for multiple sclerosis, previous therapy
with immunosuppressants might increase risk. Clinical diagnosis by use of MRI and detection of JC virus in the CSF
was established in all but one case. Management of PML has routinely used plasma exchange (PLEX) or
immunoabsorption to hasten clearance of natalizumab and shorten the period in which natalizumab remains active
(usually several months). Exacerbation of symptoms and enlargement of lesions on MRI have occurred within a few
days to a few weeks after PLEX, indicative of immune reconstitution infl ammatory syndrome (IRIS). This syndrome
seems to be more common and more severe in patients with natalizumab-associated PML than it is in patients with
HIV-associated PML.
Where next? Diagnosis of natalizumab-associated PML requires optimised clinical vigilance, reliable and sensitive
PCR testing of the JC virus, and broadened criteria for recognition of PML lesions by use of MRI, including contrast
enhancement. Optimising the management of IRIS reactions will be needed to improve outcomes. Predictive markers
for patients at risk for PML must be sought. It is crucial to monitor the risk incurred during use of natalizumab
beyond 3 years.

I am still waiting for my AZ neuro to get the info on pml. Mostly I want to know how many people are on Tysabri 3+ yrs and how many have developed pml in this time frame. I really want this info U.S. only.
Has anybody gotten this info from there neuro ?
Linda

Sorry, my typo! The study is between Tysabri, Copaxone and Rebif, NOT Betaseron!

Yeah!!!! Just wanted to check in and report that I did not get a UTI with this Tysabri infusion (and no prophylactic antibiotics either!). :yahoo:

I had #44 Mon; same as the 43 before it :D

Yesterday I spoke with my case manager to get switched back to CO from AZ. He confirmed the 42 pml cases thru 3/10, 15 in the U.S and stated there are 60,000+ users (37,000 U.S.). I then asked how many infusions the 2 newest pml cases had-didn't know and then asked how many people had been on it over 3 yrs didn't know that either. Told him since the risk is higher the longer on it (as Biogen reported) we want to know how many cases of pml over 3 yrs and how many people on it (still on it) since 7/2006.

He did say the FDA still approved the 1/1000 ratio. I want the info like we got it before 7/24/09 and told him so.
Linda
I just read new info on pml cases 41 and 42. One had 30 infusions the other 34.

http://www.businessweek.com/news/201...-update1-.html

Biogen Seeks Test for Brain Disease Linked to MS Drug (Update1)

Thought this paragraph was interesting

“Biogen is looking at other biological signs of PML risk that may be incorporated to improve the test, Sandrock said. In those who test positive, Biogen is testing for markers to further determine which patients are at high risk, Sandrock said. Those markers may include certain genes that increase the risk of a brain infection, or viral mutation that allows JC virus to live in brain tissue.”

Hey K!
I'm looking for an article about Tysabri being tested in SPMS that came out within the last two weeks. I know I had it but my filing system is a bit scattered. Is there any chance you have it at hand?
TIA!:)

Hi Linda!
Glad to hear that 44 went as well as all your previous infusions!

I can't help with the new cases of PML and the count of infusions right now but will see what I can find out when I see my doc next week.

The last time I saw him he explained the numbers and length like this: There are less people who have had more than 36 infusions than people who have had lesser number of infusions. The cohort is smaller and it cannot be compared to the greater number with less infusions. He said the data does NOT show more people with greater number of infusions coming down with PML at a higher rate than people with lesser number of infusions. He said the data actually shows that the rate seems to be trending down rather than up after 36 infusions.

He cautioned that since there is NOT a lot of data available since the number of people in our group is smaller, that the rate may change, but it is not being seen at this point. I believe that the last count I saw for people at 36-48 infusions was around 6400 people worldwide. If someone went out on a drug holiday, they restart at 1, so they are disqualified from the group. He said a drug holiday is considered as missing more than three infusions in a row, but that there are people like me, who missed one infusion or were late on an infusion due to some other reason than actually choosing drug holiday, that mess up the numbers too, but still get counted as being in a group. He also said there are people like Natalie, who are extending the time between infusions, but still receiving infusions, who are counted as being part of a group despite their changed schedule and that changes the group data, or who move from one group to another after being on a changed schedule for a longer time, due to the number of infusions missed despite being on Tysabri for a certain number of years

He said it is getting more confusing as time goes by and the numbers of people on Tysabri go up and that since he is not a statistician, he can't keep track either, but that some poor bugger at Biogen is keeping track of it all with a computer modeling system.

Biogen received a letter from the FDA just the other day, citing them for a webcast that didn't give enough detail/info/bad news about PML. According to Biogen, this webcast was for health professionals only and NOT for general population, and they can not control who releases the info to the general public. This may shut off some of the information that we, as searchers for info, have been getting from outside of "approved sources for patients" :mad: As usual, only time will tell.

As an aside, there is still Alex's site for info but it almost seems like maybe the info train is slowing for him also: http://chefarztfrau.de/?page_id=716

One thing I found as strange on his site was post # 40! It's what appears to be a sale of Tysabri on ebay/de ! Click on his one line comment and it takes you to the supposed page!

It's my sincere hope that the work being done on assays and biomarkers will help to clarify risks in the future, for all of us! :hug: