those who have been on tysabri for a long time

[lindaincolorado]

Yes Kris I loved getting infused every 28 days, especially after Copaxone's needle every day ! Now, it's even better at 56 days

I have had a couple headaches and other than those nada, zip, zilch for side effects

I know Lemtrada is now the bigger gun, but it's side effects make me think (at least) twice and if it ain't broke don't fix it. So, Ty is still my big gun of choice

[jreagan70]

As far as adverse effects of Tysabri, anyone can report and claim any adverse effect they want to. There have been thousands of adverse effects reports filed with the FDA, but the trends are already known. It doesn't appear that anything new has come up.

I've copied below the abstract from a recent article in a French pharmaceutical journal. (It appears to be like Consumer Reports in that it takes no advertising and publishes the opinions of the editorial staff.)







Prescrire Int. 2015 Mar;24(158):65-7.

Natalizumab (TYSABRI) and multiple sclerosis. With longer follow-up: even more toxic than suspected.

[No authors listed]

Abstract


The standard disease-modifying treatment for patients with relapsing-remitting multiple sclerosis is interferon beta injection, in the absence of a better alternative. In 2007, natalizumab had an unfavourable harm-benefit balance in patients with severe multiple sclerosis in whom interferon beta was ineffective, due to insufficient evidence of efficacy and a risk of life-threatening progressive multifocal leukoencephalopathy. In 2014, we found no new comparative trials focusing on the efficacy of natalizumab monotherapy in its authorised indications in the EU. Post-marketing data confirm the adverse effects identified in clinical trials, including serious and life-threatening opportunistic infections, particularly progressive multifocal leukoencephalopathy in about two per thousand treated patients (an incidence twice as high as initially estimated), and potentially severe hypersensitivity reactions. An increased risk of cancer in the long term cannot be ruled out. Post-marketing data also show that natalizumab can cause severe liver damage. In addition, natalizumab withdrawal because of progressive multifocal leukoencephalopathy almost always triggers an immune reconstitution syndrome that can lead to neurological complications or even death. In practice, regardless of the severity of multiple sclerosis, it does not seem reasonable to expose patients to the many serious adverse effects of natalizumab for such an uncertain benefit.

Without the text of the article and its references, it's impossible to know how they came by their data that the PML incidence is twice as high as initially estimated. That could be true, but that apparently hasn't been looked at in sufficient numbers yet.

There are people (professionals and patients) and clinical trials data that dispute the claim that, in 2007, there was "insufficient evidence of efficacy," and enough data that would dispute that statement now, after 10+ years of post-market data. It could be that this applies only to the EU, as worded in the abstract. The data from the US doesn't yet appear to bear that out.

Of course it's true that more serious, adverse effects are known of now than there were in 2005 or in the 2007 comparison point used in the abstract. But there hasn't been anything new revealed in say, the last 5 years. So, unless they're truly privvy to secret information, it seems to me like they're just repeating information that's already known.

The adverse effects they object to are already well known, primarily the risk of infection, particularly opportunistic infections, more specifically PML. Also specified is immune reconstitution syndrome. We already know about the cases of severe liver toxicity.

They cite "potentially severe" hypersensitivity reactions. But any drug has the potential to cause severe hypersensitivy reactions. Tysabri is far from the only drug administered with an antihistamine. People have died from adverse reactions to simple antibiotics that couldn't have been foreseen.

"An increased risk of cancer in the long term cannot be ruled out." That's a pretty general statement. The same can be said for any immunosuppressant used in any disease.

Not long after Tysabri was returned to the marketplace, there was an alarm sounded that Tysabri might be contributing to melanoma when a few patients on Tysabri developed melanoma. A subsequent study found that the incidence of melanoma in patients on Tysabri was actually lower than in the general population.

This article is a conservative opinion that appears to be comparing what's known about Tysabri now, in 2015, to what was known in the first few years after regulatory approval. But again, unless the authors have secret information, there's not much, if anything, new here.

And for the record, the same journal objects to Lemtrada as also being too dangerous to use for MS.

I'll opine that this is the same opinion that, because MS itself is so rarely fatal, probably slowed the development of immunosuppressant medications for MS for years. People with lupus and other autoimmune diseases, and transplant patients, have been taking the same risks for decades.




All of this can be tempered by other supporting information of new dangers and new risks with Tysabri. I'm just waiting for there to be some.

[pennstater]

Thanks jreagan. Glad to read - your post reassures me. Your last paragraph says it all - show me the evidence!

[shel67]

I talk to doc today and he said I can choose which ever med I want including TY. He said copaxone was first choice because its quicker to get to me and I need to be on DMD quickly. Aubagio was next when I said no to doing shots because it is quicker to get me on due to how the other meds require more paper work and G with the montering, etc. He said he doesn't have a problem with me doing TY and it may be good for me but its more difficult but not impossible to get assistance due to the infusion center cost.

So the bottom line is I need to pick Aubagio or copaxone for the short term to get on something, and once I can switch, I can. He is setting up all the tests for TB if i do Aubagio and blood work for JV virus if I try to get TY.

So I guess its Aubagio and then I'll switch to either G or TY because I feel they are more effective in my situation.

Any thoughts?

[jreagan70]

Hi shel:

Any thoughts? Yes.

I think you should take a minute -- an hour would be even better -- to stop and appreciate yourself and give yourself proper credit for the really awesome job you've done in steering yourself through the diagnostic process, educating yourself about MS and treatment options, and speaking up for yourself with your neurologist to choose your DMDs.

Then I'd like to give props to your neurologist for understanding how big a factor logistics can be in getting patients onto medications, and choosing the most immediate options of meds with the least red tape involved so you can get on a med as quickly as possible. His recognition that you should be on a DMD as quickly as possible, his proactiveness in getting your pre-med testing done, and his open-mindedness in allowing you any DMD option of your choice are all good things to be appreciated.

Lastly, it sounds like you've thought things through and made you DMD choices logically. Another .

I can't find a glitch in anything you've said. Excellent.

[pennstater]

Congrats. As jreagan said, way to become your own advocate. Given the options you laid out (no shots), it does sound like you have made a wise choice. The last conversation I had with my neuro before he retired, for me, he was advocating the other way. If I ever need to come off Ty, Aubagio, unless of course some new drugs introduced.

Let us know how things go. Keeping my fingers crossed for Ty as an option.

[shel67]

Thanks... I'm narrowing it down to TY if it's possible due to infusion cost, and Gilennya. I have to take into consideration daily side effects due to my job. Being sick with migraines simply will defeat the purpose. The challenge will be to give it the time it needs to adjust and be functional. Another reason TY is appealing, less day to day side effects but the infections worry me. I work with public.

[perkylady]

Thanks... I'm narrowing it down to TY if it's possible due to infusion cost, and Gilennya. I have to take into consideration daily side effects due to my job. Being sick with migraines simply will defeat the purpose. The challenge will be to give it the time it needs to adjust and be functional. Another reason TY is appealing, less day to day side effects but the infections worry me. I work with public.

If you have decided on Tysabri do call Biogen and ask about their help with co-pay. I wish someone would have told me about it sooner; would have saved a bunch but thought income was too high even after I did hear about it. Most people qualify for their assistance program which can cut your copay by $100 on the med and another $100 on the infusion. That is a welcome reduction in co-pays and most qualify for it; I believe income of 100k or more does not disqualify so give them a quick call, you may get surprised by how helpful they are.

If you have decided on Tysabri why mess around with another med? It can only delay the process of getting on Ty. If you plan to receive a different DMT for only a few weeks most DMTs will not become effective in that time frame, anyway. You are going to get a blood profile on any DMT; the only additional test with Tysabri is JCV. The results are usually reported within 10 days, two weeks at the most. Getting insurance approval may take that long, depending on the insurer. May take just as long for any other MS med but switching meds may slow the new approval. Wonder if taking the slow route to Tysabri is the best route if you are going there?

Best of luck whichever way you go!

[shel67]

jreagan is correct in that you need to become your own best advocate and understand the stats.

Most of the pharmaceuticals have programs for people without insurance. The problem you may have though is getting the recommended bloodwork and MRIs needed based on your jcv titer and length of time on Tysabri. This is something you do need to consider and see if there is any assistance available.

As for side effects, when I was first worried about starting a DMD due to side effects, my neuro told me to go home and read all the side effects for aspirn and other anti inflammatory/pain relievers. His point to me was that all medicines have side effects, but it is really important for me to understand the statistics to evaluate the risk to me given any other health condition. And some may be unknown to me, a risk in itself. That is the only way to make as informed a decision as I can. By law, they have to report all side effects, so really need to understand the numbers.

As for Tysabri, I was beginning to relapse more frequently, so it has slowed that down. I do have some worsening of symptoms, but mostly sensory that has not affected my EDDS score. MRIs mostly unchanged, but slight shrinkage in largest cervical lesion. Also, OCT by opthalmologist showed slight improvement in thickness of retinal nerve. So I guess some clinical improvement.

I am in the group that starts to feel it the week before next infusion. Fatigue really increases, which then causes increase in other symptoms. I also have had 4 respiratory infections in 12 months. Even with this, I hope to stay on Tysabri as long ad I can.

Good luck to you.

How long have you been on TY?

[shel67]

She'll - I am curios. Aside from the PML risk which increases as JCV titer increased, as well as number of infusions, what are dangers you are referring to?

PML risk can be managed, terminating use of Tysabri if too risk, and also by use of MRIs.

There is also the Rebound effect when Ty is discontinued.

Aside from that, I am not aware of all the danger you reference.

just from folks who, I guess couldn't tolerate it. One woman who flat lined during an infusion and almost died. I'm worried like crazy about shingles. Worried about menengitis, encephalitis.

[shel67]

If you have decided on Tysabri do call Biogen and ask about their help with co-pay. I wish someone would have told me about it sooner; would have saved a bunch but thought income was too high even after I did hear about it. Most people qualify for their assistance program which can cut your copay by $100 on the med and another $100 on the infusion. That is a welcome reduction in co-pays and most qualify for it; I believe income of 100k or more does not disqualify so give them a quick call, you may get surprised by how helpful they are.

If you have decided on Tysabri why mess around with another med? It can only delay the process of getting on Ty. If you plan to receive a different DMT for only a few weeks most DMTs will not become effective in that time frame, anyway. You are going to get a blood profile on any DMT; the only additional test with Tysabri is JCV. The results are usually reported within 10 days, two weeks at the most. Getting insurance approval may take that long, depending on the insurer. May take just as long for any other MS med but switching meds may slow the new approval. Wonder if taking the slow route to Tysabri is the best route if you are going there?

Best of luck whichever way you go!

well I don't have insurance and the MS specialist I'll be seeing said Biogen will give me the med at no cost but the infusion cost is what'll be the problem. He said it's difficult, not impossible. The MS Clinic is involved in trails and I know there was one for TY to draw the blood of patients to have to research in the event PML is contracted. So maybe that's an option.

And I have thought about starting Aubagio just to stop and then there's the wash out.

But in light of a letter the MS specialist hand wrote me, he listed all the tests I am set up to take next week, EKG, some TB lung test, and labs... He gave me the name of who to ask for and who to call if I get lost. He also sent me the paper to take to Quest for the MS JVC virius test. He even added how to find the Quest location nearest me. He also set up a way for me to email him. So based on limited resource and free care, I'm doing good I think. The two MS specialists are the best in this region. The only draw back is not having access directly to their MS clinic nurses.

As far as MRIs, that's not a problem. Im set up to have another one. Going through the university hospital they're covering it. There's no insurance company or Medicare goverment to deal with. If doc orders test, then I get the test. I qualify for "free" care. The Specialist also pushed up my appointment to August 3. It was set for October. He also set up a neuro opthalmologist appointment in a few weeks. So I'm very pleased.

I feel in some strange way that I'm better off at not having insurance as long as the state keeps funding this hospital. I'm in New Orleans, Louisiana going through LSU and with Bobby Jindal that's not a given, he's cut so much to do with health care and mental health took a bad hit from him. And this fool wants to run for President. Lord help us all.

I do feel blessed that I was able to get so much done, I just wish I would have pushed last year but symptoms were so mild and they went away, it was easy to write it off as anxiety and peri menopause. I feel TY is my hope for keeping me working and just getting some of these symptoms to just calm down a bit. I just need to get a little bit better to be able to function some what. Having days that feel I may start to get better and then the next day feeling like I've gotten even worse is wearing on me. Is that typical for this disease?

[shel67]

Oh, and the "dangers" is anemia and I am worried about it too since I been anemic my whole life. Makes me wonder about things... What that may have to do with me having MS. I'm also concerned about joint pain.

[pennstater]

How long have you been on TY?

Since 7/2012, so almost 3 years. To be honest, I don't even think of risks anymore. I know they exist, but it has become just like any part of life. I don't know what tomorrow brings, MS or no MS, Tysabri or no Tysabri.

But in the beginning, I did think about it more, sometimes obsessing, and woukd second guess whether right thing to do. In the end, I wanted to stop progression, and Ty gave me that opportunity.

I had to put my trust in what the medical community had learned about Ty and its associated risk factors.

[pennstater]

just from folks who, I guess couldn't tolerate it. One woman who flat lined during an infusion and almost died. I'm worried like crazy about shingles. Worried about menengitis, encephalitis.

One of the tough things about some of these reportings is that you don't know what other health factors were in play at the time.

I haven't heard anything that Ty raises your risks for these.

I know respiratory infections and UTIs are increased risk. Even with the once tions I have had, still worth Tysabri.

If you choose Ty, your neuro will monitor you WBC count and JCV titer among other things. This helps reassure me that risk of any severe reaction is limited.

[shel67]

Since 7/2012, so almost 3 years. To be honest, I don't even think of risks anymore. I know they exist, but it has become just like any part of life. I don't know what tomorrow brings, MS or no MS, Tysabri or no Tysabri.

But in the beginning, I did think about it more, sometimes obsessing, and woukd second guess whether right thing to do. In the end, I wanted to stop progression, and Ty gave me that opportunity.

I had to put my trust in what the medical community had learned about Ty and its associated risk factors.

so it is working for you? Have you stablized? Symptoms not worsening?