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Well, I may or may not be getting my infusion on Monday. Seems my insurance deductible went from $1000 a year to $1500 without any notification to me! On the plus side, i was approved for medicaid due to the not being able to work thing... still waiting in disability decision but that is a whole new topic. So I was approved for medicaid and it was back dated to jan 1... I was told.... but I still have not received my card or any info on it. But I still have my Cobra until mid Feb.
The hospital was told by the Cobra ins that I had to pay the $1500 for the infusion. They are willing to make a payment plan with me, provided I come up with at least $300 by Monday.... Kind of hard to do when I haven't worked in over a year and SSDI has me in limbo once again... My only income right now is child support... so now I dunno. Hoping it can be resolved tomorrow. |
Tysabri #42 past Fri
Still love my Ty but concerned about odds of pml with over 40 infusions :( More info now at chefarztfrau.de/?page_id=716 On this site it lists a pml case as having 52 infusions; only possible if from trials and they haven't counted those users in the stats. (now I'm wondering if in the U.S. - think it was :confused:) Wish my rememberer was better :p
I found on another article that there are 2,000 on Ty over 3yrs. If this is world wide:( if only U.S. better but, still not great. Wishing all of us well, Linda |
Well, darn!! :mad: I took my prophylactic antibiotics (the day before, of, and after the infusion) and then 2 days after I stopped I got a UTI again!! Ergh. I've wiped it out with a week of Cipro and a shot of 1 gram of Rocephin from the urologist.
But I don't think the neurologist will be happy. Clearly I am now destined for continuing the Tysabri every 8 weeks plan. The urologist did give me a week's worth of antibiotics to take when I get future infusions--maybe that will prevent any more but I don't like having to take so many antibiotics. On the other hand, I don't want to go off Tysabri. :( |
Yikes Natalie!
I do NOT envy you! One was enough for me! |
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Have you heard anymore as to whether you can get some help? There are options out there. Biogen cannot help with infusion costs but one of these resources may be able to help. You could also call Medicaid and tell them what is going on and maybe they will give you your numbers, since you are already approved. GENERAL FINANCIAL ASSISTANCE Partnership for Prescription Assistance (888) 477-2669 The Medicine Program (800) 921-0072 NeedyMeds: (978) 865-4115 National Organization of Rare Disorders (NORD): (203) 744-0100 Rx Council (866) 794-3571 Alternative Funding Group (866) 426-2906 Patient Access Network (866) 316-7261 Bridges to Access (866) 728-4368 Rx Outreach (800) 769-3880 |
Natalie, so sorry you just keep getting UTIs :hug: I give you so much credit for hanging in ... I love my Ty but don't know if I could/would be as tough as you! I guess I would have to be... Maybe every 8 weeks will give your body time to recover so you won't get a UTI. I truly hope so!
Linda |
PMLs
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1/ What is PML? (Looked it up in the site med directory to no effect) 2/ What other side effects should I be aware of? My granddaughter the has been advised by her neurologist to change from Copaxone having previously spent 3 1/2 years on Rebisf. She is very concerned about serious side effects! Regards Harryp |
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Soory to hear why you are here but kudos to you for your research for your granddaughter. I'll give you some links for reading and if you have questions come on back and someone will help you find the answers. 1) PML: Progressive multifocal leukoencephalopathy http://www.nlm.nih.gov/medlineplus/e...cle/000674.htm 2) Other side effects: Everyone's different. Some folks have no side effects and some have a lot of them. The best place to read about side effects is from the patient medication guide. You can find that by going here: http://www.tysabri.com/en_US/tysb/si...I-medguide.pdf There's a wash out period before starting Tysabri that lasts 2 weeks or more depending on what drugs have been used before Tysabri and how long the neurologist feels the patient might need. I hope this helps! Feel free to ask whatever you need to know and if someone can answer, they will. |
PML Info just became public on FDA site
http://www.fda.gov/Drugs/DrugSafety/.../ucm199872.htm
Table at the bottom breaking out PML rates in the US and Europe. |
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I love my Ty but the more I read about PML the more concerned I am. I didn't get my dose last Friday. I'm putting it off 2 weeks because I'm going to California again for my grandson's b'day and I don't want to worry about the side effects I always get. But, I've never gone 6 weeks between infusions except for last summer when I was ill and couldn't have an infusion. Darn.......I hope I've made the right decision. If it does go ok I will try to continue to get an infusion every 6 weeks instead of every 4 weeks. Good luck everyone...hugs, Shayna |
Biogen Earnings Transcript related to Tysabri/PML
http://seekingalpha.com/article/1876...e=yahoo&page=3 “We continue to explore avenues for stratifying risk. One key area of focus is on the development of a serological assay to detect the presence of JC virus antibodies. We are currently planning to initiate a clinical study to determine whether antibody negative patients are at lower risk for PML. Our aim is to make these studies widely acceptable to TYSABRI patients worldwide.” http://seekingalpha.com/article/1876...e=yahoo&page=7 “Joshua Schimmer – Leerink Swann, LLC What is the design of the study and what will you specifically be measuring or following? James C. Mullen If we’re talking about the serological assay study, it’s basically simply a blood draw where we take the blood, store it. We actually have a couple of studies, in one study we will verify that the findings we got from our strata samples is the same. We will match it up with urine JC Virus. In the other study we’ll collect blood and see whether or not when patients develop PML they were antibody positive at that prior time point or not. Joshua Schimmer – Leerink Swann, LLC Is it just the antibody? What are the JC virus specific T cell function assays or the viral protein assays that you’ll also be monitoring? Do you only check those if patients are positive or do you test everyone and see who gets PML? James C. Mullen Those will be separate studies done in a focused way in conjunction with some registries and other studies going on in Europe and elsewhere we will look for additional biomarkers. They will include cellular assays as you indicate that test immune response, they’ll also look for mutation in JC virus. If we get a technology we can use to measure mutations and so forth but there are some studies that are going to be underway for example in Germany that we intend to collaborate with the investigators who are doing those studies.” |
Excerpts from Elan's Conference Call'
http://seekingalpha.com/article/1878...nscript?page=8
"Carlos V. Paya M.D., Ph.D. Annie, this is Carlos. Thank you for the questions. The three sub questions, the assay — there are a number of steps that are very clearly outlined to regulatory pathways so the assays can become commercially available. One of them is to gather additional information because as I mentioned, the data that we have as to how this assay was generated was using source samples that had been prospectively collected, but that was not the whole purpose of those collections. So we really need to now do a very thorough evaluation using prospectively collected sample studies where we are going to study in the upcoming months trying to validate two things. One is the sensitivity and the specificity of this test by comparing serologies we saw with viruria using PTR. That’s one of the ways to validate test. The other one is to then – once you have a test validated is that seropositivity always precedes or concurs with the presence of PML. I recall that already with the PML cases we have, we did have 11 cases where we had samples drawn ,and those 11 cases were already positive. Our goal with these additional studies is to now confirm those findings, which will then bring the reassurance for everyone that it can clinically predict the PML appearance. With those two packages then, that is what you proceed forward with regulatory path for approval to become a commercial test. In the meantime physician incorporating and signing up with these studies will have the chance to be running the test in their patient samples. And therefore have the ability to understand more results coming out to them. " http://seekingalpha.com/article/1878...nscript?page=9 "Carlos V. Paya M.D., Ph.D. I’ll take a number of questions there. Maybe Shane can help us with the profitable numbers in the US. So with regards to the exact timing, I cannot provide any guidance right now. We are in the midst of discussions with both regulators in the US and Europe. So we can have additional strategy after this discussions after the – kind of narrowing down the timing. But right now our objective is to as quickly as possible, roll out these two separate studies. Again, one to validate the (inaudible) in perspective samples. And two, by the clinical reliability to predict PML. Those data need to be available, I think, for a robust package for rapid approval. (Inaudible) discussions we’re having with the regulators. " |
Based on the above posts, Tysabri patients should check with their Neurologists to see if they'll be participating in one or both of the two JC Virus Antibody assay studies.
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Question for you lovely Ty users! Went in earlier this week for #3, they didn't do any blood work this time. I don't know if it from the new ins or what but they always took blood before though I was never told why.
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Chris |
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You should ask why you have them and get details. Are you in a trial? You should also ask them why they didn't do it this past infusion. They are human and maybe they forgot?:p When something is new or different I always ask why, cause I am a pain in the ... infusion center...:D |
LOl pain in the infusion center? you too?? They run screaming when they see me coming! No one wants to be the one to stick me because NONE of them can ever get it on the first try.
There was this one time, the chick was great, Iv was in first try and all. 10 minutes later it blew and my whole arm swole up. |
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It's not the stick that scares them, it's me...;) |
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New $10.00 co-pay program for Tysabri. It does NOT help with infusion costs , just the drug. The brochure should be available in your neurologist's office, or I believe you can call MSActiveSource and they will steer you to the right person to talk to.
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I get my blood drawn every 3 months to test how my liver is doing on Tysabri. Usually they collect the blood when I go in for my infusion--that way I don't have to make a second trip to the lab to get the blood drawn. It saves being poked twice!
I have to say, I just read that conference call with Elan regarding the assay to test for JC antibodies. The doctor Carlos V. Paya M.D., Ph.D., who is answering questions, is really bad at explaining things and answering questions-I can't follow half of what he is saying!! And it's not because it's technical/medical language! |
Now there have been 35 cases of PML
There have now been 35 cases of PML in Tysabri patients:
http://www.businessweek.com/news/201...ase-cases.html They're saying that the risk is still within the expected range, and so Tysabri is still considered safe. |
Here is a link to an article coming out in "The Lancet" in March 2010 on the JC virus, PML, Tysabri and the immune system.
http://www.thelancet.com/journals/la...006-5/abstract |
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Linda |
Looks like the JC Virus Antibody Assay will be here soon
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That's great news!! BUT....my question is this: the time frame for the studies is 2 years so does that mean this assay will not be commercially available until 2-3 years from now? :(
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I think we will be the people testing it, Natalie...
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I am still confused! |
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Basically, Tysabri caused an increase in the proliferation of the viruses but the body's humoral response remained stable. This means that the body wasn't making any antibodies to the viruses so it wasn't launching an attack. This is why it said that although there was an increase in the viruses there was no sign of reactivation. One only would see symptoms of reactivation if the immune system was launching an attack as that is what creates the symptoms. If the virus actually gets so concentrated it will interfere with function and then of course you have morbidity which can be fatal. The viruses were being proliferated in the body but the immune system wasn't launching an attack and that certainly is not good! There still appears to be so much we don't know about PML and it's connection with Tysabri. Hopefully this test will become available soon. Harry |
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This is what the scientific experts concluded in the paper "Interpretation Natalizumab increases cellular immune responses specific to viruses and myelin proteins in the peripheral blood after 1 year, without evidence of viral reactivation." |
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Harry |
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Harry _____________________ There is difference between cellular immune response and humoral immune response. Cellular immune response, also referred to as a Th1 response, is a cell mediated response indicative of inflammation and cell destruction. Which is what Tysabri increased. The humoral response, which the article states remained unchanged, is a Th2 response in which the immune cells produce antibodies to viruses to destroy and prevent further and future infection in the body by the viruses. The article states that the humoral response was unchanged yet the cellular immune response was increased. This indicates that the virus is proliferating and causing cell destruction and the immune system isn't fighting back by producing antibodies. Thus, this is a silent destruction going on and the reason that they say there is no evidence of reactivation is because the body isn't launching an attack. This attack would normally produce the outward symptoms and reactivation is often measured by the number of antibodies being produced by the body. ___________________ |
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Obviously the problem with PML is that the virus is out of the bloodstream and into the CNS and Tysabri keeps antibodies out of the CNS. |
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Harry |
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The issues with Tysabri relate to infections outside of the bloodstream - I believe the only safety signal that has been confirmed through commercial use is PML. |
harry, please remember that this thread is for those who are using or inquiring about tysabri
you have been asked before to start new thread for comments or critique |
Hi all:) Wondering about other experiences with Ty. I tried copax, but late in my 2nd year my IPIRs got too frequent. I've been on Rebif for almost a year, and then had an allergic reaction to the med this past week. :eek:
My doc thinks that Ty should be the next step, and I'll be discussing it with the hubby tonight since we're a united front on the MS stuff - but also wanted to get other opinons. Been reading some of what's been posted, so it's going to be an interesting decision ahead. The above issues with the other DMD's as well as other meds make me leary to try this, but trying to decide whether or not to give this a shot. Thanks for listening. :) |
Jenn, I think you know my story. Allergic to betaseron, too many severe IPIR's on copaxone, infusion/allergic reactions on tysabri and the presence of antibodies. I know this is a tough decision to make. In a way I am glad that I tried tysabri despite the reactions because if I hadn't, I guess I would always be wondering if it was the one treatment that would help. The risk of PML's obviously also has to be considered.:hug:
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FIN-> mY experiences: I did Copax-> had no bad reactions other then injections site bumps/itching, which is normal for putting a needle in your skin. However, stopped taking it and almost all of my sx went away within 10 days, redid MRI and found C aggrivated the MS and I had a whole mess of new lesions.
Then I refused DMDs for a while, gave up beef and pork went on strict diet and vitamin regiment, worked great (Only had a few sx left) until we moved and the MS flared again. Doc wanted me on Rebif, but agreed to try Av first since it was less shots during the week. Had horrible reactions to Av, eventually started breaking out in hives and she pulled me off. My options were then given to me: Tysabri or Chemo.... and the doc was very strongly against chemo. So far (3 infusions, next one scheduled for next week), I have no side effects other than feeling drained of energy the day of the infusion. No night sweats, fever, rashes, flu like sx... so for that I am happy. BUT, the latest MRI shows I have grown more lesions and a few of the new ones are active. I have not seen an improvement in any sx so far, but again I have only done 3 infusions. In any decision you make, I wish you the best of luck. |
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Yes, I am aware that this thread is for those who are using or inquiring about Tysabri. But I believe it was Natalie who mentioned the Lancet article and others who wanted to understand what this article possibly meant. I would have thought that anyone who was considering using Tysabri would want to know what the Lancet article was stating and thus my comments from someone who was involved in MS research. If this was outside the boundaries of the thread, then I do apologize. Harry |
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