Thursday, 22 August 2013

Natalizumab PML Update: July 2013

July 2013 PML update. How many MSers have died from PML? #MSBlog #MSResearch

"The following are the latest risk figures for PML on natalizumab. Please note that the slideshow at the bottom is for professional eyes only."

"As of  2nd July 2013 there have been 377 cases of natalizumab-associated PML; 88 (23%) MSers have died from PML and 289 (77%) are alive. Please note that the majority of those surviving have a poor functional outcome."



44 comments:

  1. The number of deaths is huge! 23%? I can't believe it!

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    1. That is 88 MSer deaths out of 115,400 who have been treated with natalizumab, i.e. 0.076% or 1 in every 1311 MSers treated with the drug.

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    2. Now that we have a risk stratification policy in place the rate of new cases is dropping each month. So you need to interpret the overall figures very carefully.

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  2. THIS is a DRUG you have promoted

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    1. If you look at my disclosure I promote all of the DMTs. I don't believe in not treating active MS. Inactive MS is another story. However, it is up to you decide whether or not you want to go onto a therapy or not, it is not my decision. This is what we call informed decision-making or informed consent. Do you have a problem with it?

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    2. Anon 5:10 the fact that Prof G posts the PML figures is about informing us; I am not sure you would call this promotion. If anything it is the opposite. Like he said you don't have to start treatment if you don't want to.

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    3. This is written in the Troll Font :-)

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    4. No, MouseDoc, I am not a troll. Please don't reduce us to such a thing. Though I didn't write the above comment, I share the fear and shock at these statistics. The risks are too huge to ignore.

      The risks of natalizumab does cause shock. I don't think that I can risk it when the figure of death is so high.

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    5. The shock and the statistics are one thing. We are all shocked about
      the figures and you need to understand the risks.

      But it is the "poster of the comment" who was making it personal issue.
      Prof G will not rise to the bait, cos he is a professional :-),...but I will:-)

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    6. Before you say no to natalizumab because the risk of dying is too high you need to study slide 13 and put yourself in an at risk category. For example if you are JCV negative then the risk of getting PML is 1 in 10,000 and the risk of dying from it is only 23%. The overall risk therefore of dying from PML will be less than 1 in 43,000. In reality it will be much lower than this. Why? We monitor your JCV status every 6 months and if you convert to being positive we will reassess your risk and probably switch you to another therapy.

      The reason why the number of PML cases and deaths is falling so fast because risk stratification is preventing new cases and deaths. In other words natalizumab is getting safer. I hope this clarifies things?

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    7. It does, and thanks for the explanation, Prof G. I still cannot come to terms with the risk profile of natalizumab, at least not yet. I am sure that everyone is doing their utmost to monitor the situation, but there are still MSers dying from the drug despite being clinically surveyed. I want a safer alternative. This just seems too risky for me.

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    8. I have now had 39 infusions of Tysabri and I am positive for the virus. I know I am taking a risk, but I am not prepared to take a chance of going back to what I was like before starting treatment. My MS was so bad I am sure I would be in a wheelchair by now if I had not started Tysabri. Instead I have managed to keep my job and have recovered to a point that I call my myself almost normal. May be if a new treatment as effective as Tysabri comes along I will switch, but at the moment I am not prepared to stop.

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    9. You are covering your own backs knowing deaths have occurred on many MS drugs which is very concerning

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    10. I know I am supposed to use hedgehog and just delete these posts but as your are fishing....I bite

      Will you stop posting this nonsense!!

      "covering your backs" ..How many times have you posted this...It is not original...yes we can assimilate knowledge and so reading this once is enough......really

      Cutting and pasting is surely a waste of your time, I know it is a waste of ours. What do you mean?

      I don't prescribe, so not much to cover there
      and as for ProfG
      There are guidelines on prescribing and the risks are clearly given. It is informed choice.

      Enough said.

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    11. Yes you are...I´m quite sure our crusader won´t give a damn.
      Stop defending yourself, I think we all know where you guys stand.
      So just ignore them, that´s what I try to do, because they are not
      only offending you but me as well, I can think and judge for my self.
      Give hedgehog a hug from me..
      //Swedish Sara

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    12. or more to the point we know where the gals stand

      Hug given, I'll post a picture

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    13. August update of Hedgehog

      http://multiple-sclerosis-research.blogspot.co.uk/2013/02/hedgehog.html

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    14. With MS, one is between a rock and a hard place. Don't take DMTs then one risks the chance of degenerating; take the drugs and one risks dying from side-effects. Not a good position to be in.

      God, I wish people could figure out how this disease has happened to me.

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    15. Dear swedish sara.
      See below for evidence (deleted by administrator) that I can do it..Flag planted

      Delete
  3. I just don't see this risk as particularly high or shocking. Are we as a society too risk-sensitive when it is presented as a statistic? People take big risks - often openly - with their health all the time (smoking, obesity etc etc) but when it is put in numbers they freak out. And another thing, why are so many commentators on this website anonymous?

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    1. I understand the sentiment, but I can perfectly imagine people being cautious confronting their disease with irl surroundings. This is still the 'Interwebs', changing times, anonymity might be our last safeguard :)

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  4. Sorry, Caroline, it is just the 'faff' of creating a user profile (and I am usually taking a quick look at the blog whilst really in the middle of something else) so I have got into the habit of posting anonymously... I hope you will understand and can forgive me!

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  5. I had infusion #80 on Monday, and I am JC+. When I went over all the Tysabri info with my neurologist last week, we estimated my risk is somewhere between 1 in 350 and 1 in 400 of getting PML. The risk seems to flat line around year 4. While it looks like the odds get better, the sample is so small it's hard to read much into the difference for years 4-6.

    I repeated my choice to stay on Tysabri. For me, it comes down to perspective on the risk. If I had the most treatable kind of cancer (breast cancer caught early) and had a mastectomy, my treatmetn with lowest morbidity rate would still be chemo. Chemo has a morbidity rate around 1 in 200.

    So I look at Tysabri as the only drug allowing me to live a fairly normal life, and my odds are better than the cancer patient with the most treatable cancer.

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    1. I feel compelled to reply as the information is incorrect. If breast cancer is caught early, a patient will not need chemo unless the lymph nodes are affected. Radiotherapy may not be necessary either. Doctors do not give Chemotherapy treatment unless it is needed. Some of us choose a mastectomy to avoid Radiotherapy. It is a matter of choice, as long as we know all the consequences.

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    2. Sorry, I was under the impression adjuvant therapies of which I thought Chemo was the most commonly one used, had been shown consistently (across multiple studies) to reduce chances for recurrence and improve long term survival rates. I know this is what the Susan G. Koman group still has on their website. Has the evidence on this changed?

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    3. Like MS every cancer patient is different. In the UK you don't get chemo unless you need it. My grandmother had a mastectomy in 1927 and lived until she was 82. Me, my friends and family have all survived for more than five years without chemo, because it was diagnosed early. That is enough evidence for me. We've all been under the care of some brilliant doctors. If I needed chemo I would have it, but I'm not sure I would risk DMTs.

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  6. This comment has been removed by a blog administrator.

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  7. Re posting anonymously, we are each different.

    Sorry. I will post anonymously, or I would if required, create a unique user name for this blog. If I had to tie my posts on this blog to another account, I would never post again. This would make me sad.

    In my case, my concern is with employment. However, it is also interesting. With anonymous posts it is not always immediately clear whether a patient or researcher or doctor or family member is posting. Where there are fewer prejudgements based on identity, perhaps the ideas come through more clearly.

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  8. It's easy to post without creating an account of any kind and not anonymously. Choose Comment as Name/URL and enter your name. It is nice to see when the same people comment--almost feels like in some ways more connected to those who comment often.

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  9. Aha SamH, I didn't realise how easy it was to post with a name - thanks for that :-)

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  10. Hi Has anyone tested new pill BG 12?

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    1. Yes it is available from a chemist near you...well that is if you live in the USA. If you are in Europe we have to wait until Biogen comes to agreement with the regulators and as for UK, you have NICE to contend with.

      Please search BG12 in the search engine and you will be able to read lots about this new drug.

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  11. OOOh thanks alot, persons i know in USA recommend it highly but i do live in Europe so i have to wait then, my doc wants me to take tysabri but im too scared for it.I took avonex for 7 yrs and felt living in a ballon, i feel better now without it.Hope BG 12 comes soon then...

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  12. to Anon, 24, 11: 51.00. You could also move to Australia. BG 12 Tecfidera has been approved for prescription. We await a PBS ( public health listing) which is expected shortly. I have been following Tec user groups in the US as it has been available there since March to see what the side effects and symptoms seem to be like since its release into the real world. Phase IV study should be interesting - I suspect more drop outs then would have been anticipated. Week Three on the tabs seems to be the clincher, if you can get past the vomiting and diarrhea. Some have no symptoms at all but they seem to be in the minority. As MD said, this site has posts about the drug so read those and do some googling to find the social media sites which have Tec user sites. I've been thinking about it myself, will discuss it with my N at next visit. Always cautious about how a medication responds out of the clinical trial environment - another N said to wait two years after a drug came to market before trying, sage advice particularly in respect of Tysabri.

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  13. http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=137144&XNSPRACHE_ID=2&XNKONGRESS_ID=150&XNMASKEN_ID=900
    Many have heard or read that natalizumab is used for IBD as well as MS. Turns out that vedolizumab blocks different family of integrins in gut mucosa than integrins expressed in BBB. With vedolizumab the threat of PML is eliminated.
    Interesting FYI.

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    1. I red it a different way The abstract says "Natalizumab inhibited leukocytic infiltration into cerebral spinal fluid and the brain. Natalizumab also prevented formation of demyelinated lesions...Vedolizumab in contrast did not elicit these effects".

      So whilst I agree the threat of PML would be eliminated.....so would the disease modifying effect be eliminated as it would not work.

      Nataluzimab inhibtits Ms because it stops white cells getting in the brain you get PML becuase white cells do not get in the brain

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    2. I wasn't suggesting vedolizumab would show efficacy in MS, it only blocks the family of integrins expressed on gut mucosa. Interesting in that autoimmune disease has been shown to run in families and how the mechanisms of each overlap. Natalizumab, rituximab, and dimethyl fumarate all used in multiple conditions. The common mechanisms are interesting.

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    3. They are all immune modulars....so they are active in other conditions believed to be immune modulators.

      So action across diseases will be expected but this also their problem as each drug can be associated with side-effects so when say treating brain problem you get a gut side-effect.

      Therefore antigen-specific therapies are he holy grail.

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  14. Hi Helen, ooh yes i wish to move to Australia as you have such beautiful afghanhounds and thanks for new info about BG 12. I just wonder what is best now, i took Avonex for 8 years felt like in a box or can i heal a without any drugs???I do not want drugs and feel fine without it for 5 yrs.

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  15. Hi Anon 25, 9.18.00 you're very welcome to come here :). It's really hard to know 'what's best'. Best case empower yourself by doing lots of reading, asking questions - in the end it will be your choice on what you do based on the best evidence you can muster. If you want to look at a healing approach without drugs you could try the website of an Australian Professor of Medicine who has MS and who devised his own program of diet, exercise meditation and Vitamin D supplementation and published it on the net. There's nothing to buy it's all there, it is a very positive website. There are published stories of those who have done very well on the program, including the Professor himself. Some people hedge their bets and do the program and take DMD's as well. It's a personal choice. I wish you well.

    http://www.overcomingmultiplesclerosis.org/

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  16. Are there any researchers working on a vaccine for the JC virus?

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    1. Probably and others will be hunting for drugs

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    2. re "Are there any researchers working on a vaccine for the JC virus?"

      Yes, but it won't help you if you are already infected. It may protect those who are JC-ve and keep them negative. There also people working on a treatment for PML; the JC virus is a difficult target but not an impossible one.

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    3. Regarding a vaccine; we will need new assays to differentiate between antibodies to the vaccine and the wild-type virus. This is not trivial and will depend on whether or not the virus is a single or multi-component vaccine.

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