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85 Reaktionen zu “List of PML diseases under Tysabri (September 2010)”

1. Huri Tursan
   Am 17. September 2009 um 14:01 Uhr

   Just another point. Is there any information on the locations of the PML cases? To your knowledge has any environmental investigation been done?
   Regards
   Huri

2. Alexander Otto
   Am 19. September 2009 um 14:54 Uhr

   Sorry, I have no idea.

3. Lee Catania
   Am 1. Oktober 2009 um 20:47 Uhr

   Is there any information whether the PML patients participated in the clinical trial of Tysabri? The TOUCH program disregards infusions prior to their inception. I for one have received approximately 70 infusions (April 2002 on and off), but TOUCH does not acknowledge this in their calculation.

4. rdo
   Am 3. Oktober 2009 um 12:25 Uhr

   No, I don’t think that information exists officially. Reason being, if it did, Alex would have included it.

   However, counting doses has to have some formal reasons behind it, because it wouldn’t be scientifically correct to disregard them (even if you assume that after 12 months of a break the immune system is sort of equivalent to somebody who’s natalizumab naive). Given that, for those cases where solid date has been reported, I’d expect an earlier therapy course would have been included with the circumstances mentioned, had there been a previous course. But that’s of course just a guess and doesn’t help at all with those cases where we don’t have any solid data.

5. Alexander Otto
   Am 8. Oktober 2009 um 17:22 Uhr

   BOSTON — The virus responsible for PML (progressive multifocal leukoencephalopathy), a rare brain disease that typically affects AIDS patients and other individuals with compromised immune systems, has been found to be reactivated in multiple-sclerosis patients being treated with natalizumab (Tysabri). The findings, led by scientists at Beth Israel Deaconess Medical Center (BIDMC), appear in tomorrow’s issue of The New England Journal of Medicine (NEJM). [... more]

6. Barbara27
   Am 23. Oktober 2009 um 00:05 Uhr

   Watch how they build their very strong networks in our countries in a very peaceful and constructive way. ,

7. Sherri
   Am 29. Oktober 2009 um 19:35 Uhr

   Of the 24 cases of PML, 16 were in Europe, 8 in the United States, and 2 in Switzerland. Four people have died. Here’s where I got this information:

   http://www.reuters.com/article/companyNewsAndPR/idUSLT39797520091029

   I’m glad for this site and my Google alert I have created for Tysabri. This is the only way I stay informed of new cases. I find it disgusting that Biogen-Idec no longer gives weekly reports!

8. Sherri
   Am 29. Oktober 2009 um 19:41 Uhr

   Opps, I meant to say 14 in Europe, not 16. Sorry!

9. Sami
   Am 14. November 2009 um 09:18 Uhr

   Apparently a US woman, who was dx with PML in early Oct, passed away very recently: http://www.everydayhealth.com/blog/trevis-life-with-multiple-sclerosis-ms/tysabri-a-progress-check/?comment_id=22779#comment-22779 She was referred to as patient #14 by her brother, but I am not sure where he got that information.

10. rdo
    Am 14. November 2009 um 10:08 Uhr

    I guess he referred to the last number stated by the FDA, which was 13 at that point. Quite frankly I’m sure the “correct” case count up to that point is a somewhat minor concern for him.

11. remy
    Am 19. November 2009 um 02:07 Uhr

    Now there are 3 more cases in November according to the list? Can you give a little more info on what you mean by “internal Biogen paper?”

12. Alexander Otto
    Am 19. November 2009 um 14:30 Uhr

    Hey, someone have to do it. The rest of the news are mostly marketing: Biogen’s invisible-salesforce …

13. Richard
    Am 23. November 2009 um 16:46 Uhr

    I was told by my sister’s neuro and her attending physician that hers was the 14th confirmed case. The diagnosis took over a month. She began displaying signs of PML in early September. It doesn’t really matter what number she was only that she was another in a disturbing and growing statistic.
    She passed away on Nov. 9th. The official cause of death is listed as respiratory arrest due to pneumonia, PML and MS.
    Feel free to contact me with any questions.

    Thank you for your blog.

14. James Pattee
    Am 14. Dezember 2009 um 14:30 Uhr

    My wife was the 6th case of PML in the US. She passed away on 12/16/08.
    I will be happy to share any information and my ideas regarding TYSABRI.
    The only way we will learn is by education and communication. Unfortunately
    Biogen and the FDA have done their best to ignore me and not allow me to present my information at a hearing. That is the most difficult issue for me to understand.

    Jim Pattee

15. Sami
    Am 15. Dezember 2009 um 17:00 Uhr

    James, have you blogged about your wife’s experience anywhere? At the time of her passing, there was much discussion that the reason she passed was because she refused treatment; was that correct? Very sorry for your loss.

16. Alexander Otto
    Am 3. Januar 2010 um 18:11 Uhr

    Hi Folks,

    best wishes for a happy and successful 2010. Perhaps there will soon be some good news? I think about the blood test for pml-prevention, so let the fingers crossed.

    Greetings
    Alexander Otto

17. Erin
    Am 8. Januar 2010 um 03:09 Uhr

    Thanks for this site—I have it bookmarked and make sure I send it to people. It’s really helpful for those of us on Tysabri.

18. Jacque Littleford
    Am 21. Januar 2010 um 22:21 Uhr

    I was diagnosed with MS in 2001. I have been on several therapies for MS, moving from one to the next as exaserbations occur. I have been on Tysabri now for 18 months. My previous doctor wanted me to take a “medical vacation” of Tysabri for three to six months. Just prior to that discussion, I had an MRI that showed 1) no new or active lesions, and 2) a reduction in the size of many of my lesions. Due to the stability of my lesions, I have declined the “medical vacation” and have found a new doctor. I don’t know if this was a wise decision, on my part, but I am comfortable with it.
    What are the very early signs of PML? What should I do if I start experieninng these symptoms? (Other than bringing it to the attention of my doctor.)
    My MS is stable, perhaps being reduced, by the Tysabri. So, what’s a girl supposed to do?

19. Alexander Otto
    Am 22. Januar 2010 um 08:56 Uhr

    21 January 2010 — EMA/37607/2010 – Press Office

    European Medicines Agency recommended today additional measures to better manage risk of progressive multifocal leukoencephalopathy (PML) with Tysabri

    #Risk of PML increases after two years#

    The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that …[read report: http://bit.ly/5OSuz5 ]

    More information about the review of the Tysabri chemical is available in
    “Questions and Answers on the review of Tysabri (natalizumab)”
    | Outcome of a procedure under Article 20 of Regulation (EC) 726/2004 |
    [here: http://bit.ly/5UNZ2U ]

20. Jacque Littleford
    Am 22. Januar 2010 um 18:07 Uhr

    After I wrote, yesterday, I went out on the web, hoping to find infornation about PML. I found 1) the clinical description of the effects of PML on the nerves, and 2) the odds of contracting the disease for “anyone on any immune depression therapy”. I had, until then, thought it was just in MS patients.

    I still, however, have yet to find a list of early warning signs of PML. Is it that PML suffers are as “unique” in their symptoms as are the patients with MS, or, are the syptoms too much like another problem that only doctors can perceive the onset of PML?

    I am not currently experiencing any “odd” symptoms, but it would be comforting (for me) to know just what I should be looking for, in regards to “the early signs of PML”.

21. Alexander Otto
    Am 22. Januar 2010 um 19:10 Uhr

    Hi Jacque,
    try this (google translation from german) …

22. Alexander Otto
    Am 25. Januar 2010 um 09:03 Uhr

    BY THOMAS GRYTA , Wall Street Journal.

    Monthly Updates Set for MS Drug

    Biogen Idec Inc. will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech firm strives to….
    
    Thank’s Noel! – Danke

23. Jacque Littleford
    Am 28. Januar 2010 um 16:21 Uhr

    Thanks Alex,
    The links you provided gave me the insight I needed. When I think of viral infections, my mind goes to stomach ailments and body aches. Memory problems were not what I thought about when I was contemplating the symptoms of PML Don’t most MS patients normally develop memory problems during the natural course of the disease?
    Of course, in my case, the memory difficulties have been sluffed off as “due to the normal process of age.” The way I cope with my MS is, to be in denial. The doctor says that it is all right to be in denial, as long as I 1)take my medications, 2) have my yearly MRI and, 3) see my doctor on a regular basis. I suppose this approach is fine, it works for me! I will, however, file this information away in the recesses of my little brain, and pay more attention to the problems I have in the memory department.
    Jacque

24. rdo
    Am 28. Januar 2010 um 21:13 Uhr

    Memory problems ARE common with MS, and people with MS can also present other mental symptoms. But it’s not very common that just MS takes it to the degree that is described in that post, and if so, it’s a long process.

    The course and rate of deterioration is relatively specific:
    MS relapses take hours and days to develop
    PML symptoms develop over days and weeks
    long term processes with MS (such as worsening memory) can take months to years.

    This means that fast deterioration of mental symptoms is rather indicative of PML than MS, but it might not be so easy to distinguish between an MS relapse or PML when it comes to other symptoms.

    Bottom line, when in doubt, an additional appointment at the doc won’t hurt.

    On a side note, the difficulty with all kind of mental symptoms is .. are you actually able to notice them after your brain has taken damage? I wouldn’t be sure. If you tell the same things over and over again, you’re probably not able to tell there’s something wrong about you, or at least it might be very subtle to you while blatantly obvious to others. So the best advice I can give is, make others aware of the risks and what to look for as well.

25. Riverwild
    Am 29. Januar 2010 um 01:05 Uhr

    @ Jacque,

    Any changes in affect, thinking, verbal skills, vision, weakness on one side of the body, or any change from the ordinary should be checked ASAP. The lesions from PML differ in shape from MS lesions, and a radiologist who has experience should be able to tag them as suspicious, but the best defense is to be alert to changes that may or may not resemble relapse and to report them immediately.

    The consensus at this point for most doctors who prescribe Tysabri and keep up on the medical news is to stop Tysabri, and look for more evidence through LP and MRI. If there IS evidence on MRI or CSF, start treatment for PML with plasmapheresis and mefloquine.

    I hope that helps! My doc said that since there are no new lesions and no enhancing lesions since my 6 month MRI, that anything new will be examined VERY closely.

    I had my 35th infusion today with no problems or concerns since I started.

26. Sandra Levine
    Am 25. Februar 2010 um 16:07 Uhr

    Alex,
    I just wanted to thank you for this blog. You are providing a great service to all of us Tysabri users–this information is not available anywhere else. Biogen has obviously tried to keep information about new PML cases quiet, but that’s the beauty of the internet: no more secrets. So, a million thanks to you!
    Sandra

27. Alexander Otto
    Am 18. März 2010 um 14:57 Uhr

    

28. kim
    Am 19. März 2010 um 03:23 Uhr

    I just wanted to thank you for this site. I was one of the original Tysabri patients from the study in 2001 at the University of Penn Hospital. I was on the medication for 3 years before it was taking off the market and then another 2 years after it was put back on the market. My neurologist took me of the medicine about 6 months ago and I have not taking anything in place of it. I was doing great on the medicine without new lesions or exacerbations. My walking has worsened and so has my congnitive function. I do not think I will ever go back on it because of the PML cases. I am just wondering why Biogen/Pharmacutical company is not following the patients that were part of the phase 2 study and that have been on the medication for more then 2 years. Following all Tysabri patients by the drug company may provide needed data to to support or not the taking a Tysabri Holiday.

29. joe
    Am 23. März 2010 um 09:54 Uhr

    A full review of the first 28 PML cases treated with Tysabri with a full status outcome can be found in the Lancet Neurol 2010; 9: 438–46

30. CS
    Am 23. März 2010 um 16:49 Uhr

    @joe
    How can I get it, without paying $31,50? Do you have the article and could mail it to Alex?

31. Macanu
    Am 25. März 2010 um 19:57 Uhr

    Was bedeuten denn die je drei Zahlen in der Grafik?
    Zb >=24 Dosen: 1.06 und 2.19 sowie rot 1.55.
    Wie ist das zu verstehen?

    Danke und Gruß

32. Alexander Otto
    Am 26. März 2010 um 08:32 Uhr

    @ Macanu,

    Erläuterung: In der Grafik wird die Inzidenzrate (das Risiko) für PML-Infektionen nach Anwendungsdauer dargestellt. Die Inzidenzrate für den jeweiligen Zeitraum wird berechnet, indem die Zahl der PML-Fälle durch die Anzahl der behandelten Patienten geteilt wird.

    Die Breite des Konfidenzintervalls (1.06 bis 2.19) ist ein Hinweis auf die Genauigkeit der Vorhersagen. Je schmaler das Intervall, umso wahrscheinlicher ist die aktuelle Aussage (rote Raute) für den betrachteten Zeitraum.

    Das für die Marktzulassung relevante Risiko von 1 zu 1.000 ist als rote Strichpunktlinie unterlegt.

33. Macanu
    Am 27. März 2010 um 20:28 Uhr

    Wie kommt man denn dann auf die “Breite des Konfidenzintervalls”?
    Die “Zahl der PML-Fälle durch die Anzahl der behandelten Patienten” ergibt doch nur ein Ergebnis?

    (Oder ist das Stichwort “komplizierte mathematische Wahrscheinlichkeitsberechnungen die man nicht auf die Schnelle erklären kann”? )

34. Chefarztfrauenfreund
    Am 27. März 2010 um 21:15 Uhr

    Das mit dem Konfidenzintervall ist nicht ganz trivial.
    Kann man hier nachlesen:
    http://de.wikipedia.org/wiki/Konfidenzintervall

35. Alexander Otto
    Am 28. März 2010 um 09:39 Uhr

    Das angenommene Konfidenzintervall ist übrigens CI = 95 Prozent – was immer das bedeuten mag

    by the way: this is the english list …

36. Alexander Otto
    Am 29. März 2010 um 15:17 Uhr

    Impact of IL17 on MS Drugs in the Pipeline, and Potential Applicability in Progressive Multifocal Leukoencephalopathy (PML)

37. matt
    Am 5. April 2010 um 12:40 Uhr

    Guten Tag,

    Can someone help? I’m trying to determine the overall risk ration for PML based on the confirmed 42 cases for pts treated with Tysabri for 0-24 months, and 24-36 months.

    Thanks.

38. Alexander Otto
    Am 5. April 2010 um 13:17 Uhr

    This is merely my estimate!
    Approximate risks without prior mitoxantrone-therapy:
    < 24 infusions 1:1000
    > 24 infusions 1:700

39. joe
    Am 5. April 2010 um 13:40 Uhr

    @ matt
    While the risk of PML per 1000 patients treated with Tysabri provided by Alex may be a fair estimate, one should remember, based on the table provided by the FDA on Feb 5th, 2010 (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199872.htm) that the risk for PML differs between the US and outside the US.

40. Alexander Otto
    Am 8. April 2010 um 18:01 Uhr

    Look at this …!!!

41. Alexander Otto
    Am 10. April 2010 um 12:59 Uhr

    Biogen Races to Create Test for Brain Disease Linked to MS Drug

42. joe
    Am 13. April 2010 um 10:16 Uhr

    Some more details about the 42 PML cases
    “As of March 9 there have been 42 confirmed cases of PML among patients exposed to natalizumab. There has been one case of PML that occurred with less than one year’s use of natalizumab. All the other cases occurred with more than a year’s use”….”Strangely, while most of the use of natalizumab is in the U.S., most of the cases are in Europe for reasons that are not clear”…”about 58% of the use of natalizumab is in the U.S., but about 70% of the cases of PML have occurred among European patients. Full information on all the patients is not known, but 11 of these individuals have died…”

    http://www.medpagetoday.com/MeetingCoverage/AAN/19507

43. Alexander Otto
    Am 16. April 2010 um 08:41 Uhr

    Biogen Idec Inc. (BIIB) disclosed four more cases of PML in Tysabri treated patients bringing the total number of cases to 46 as of April 6, (two additional deaths bringing the total to 11). Of the new cases, 17 were in the U.S., 26 were in the European Union and three were in other areas.

    http://online.wsj.com/article/BT-CO-20100415-713586.html

44. James Pattee
    Am 19. April 2010 um 03:11 Uhr

    I would be happy to provide information on my wifes death from PML in December 2008. Her sase was #6

    J Pattee
    USA

45. James Pattee
    Am 19. April 2010 um 03:12 Uhr

    Apologies

    Her PML case was #6 and was fatal.
    JPattee

46. James Pattee
    Am 19. April 2010 um 03:20 Uhr

    I noted a question from December 2009 regarding my wifes case and whether she refused treatment? Curious why this was asked?

47. Sami
    Am 19. April 2010 um 20:21 Uhr

    James, that was the ugly rumor at the time, that she potentially could have survived if she hadn’t refused treatment.

    Alexander, why are the counts separated into i.e. “US”, which is one country vs. the “EU”, which is many countries? Where would i.e. Australia fit in that, if someone there got PML?

48. Alexander Otto
    Am 19. April 2010 um 23:36 Uhr

    Hi Sami,

    this are the only available figures from Biogen today. As soon as I have better information I will complete the table …

    @ JPattee,

    did your wife refuses treatment? I could understand such a decision in the worst case.

    Alex

49. Alexander Otto
    Am 5. Mai 2010 um 11:10 Uhr

    Stan Swartz via facebook: URGENT BREAKING NEWS ON TYSABRI!!! YOU NEED THIS SIMPLE BLOOD TEST IF YOU ARE ON TYSABRI OR YOU ARE THINKING OF TAKING TYSABRI?

50. AZErnie
    Am 6. Mai 2010 um 18:06 Uhr

    Please recognize that there has not been one proven case of MS and PML at the same time. It is my opinion that the low incidence of PML allows for the possibility of pre-existant (before the use of Tysabri) PML infection which has been held in check by those same immune cells that are overactive in MS. The presence of minimal PML symptoms, which mimic those of MS, may go unreported in many cases and the possible PML infection never goes beyond mild (occasional numbness, short lived confusion, visual disturbances, etc.) symptoms which abate without treatment. But, if treatment is sought, and any form of therapy interferes with the existing immune responce, there could be a danger of enhanced infection. Tysabri, in this specific instance, could be such a therapy. It is clear, the possibility of a PML infection must be determined before the administration of Tysabri. If there is any question, Tysabri must not be used.

51. rdo
    Am 7. Mai 2010 um 10:07 Uhr

    The work of Koralnik(sp?) etc suggests that for PML to happen viruria and then viraemia need to happen first, along with a key mutation that enables the virus to enter the CNS, and each stage would take several months at least.

    Considering that the re-enabled immune system eliminates JC virus from CNS considerably faster than that, I think that makes a pre-existing PML very unlikely, much more so a chronic/dormant one where a patient might present symptoms every now and then.

    That said, if you got some other immunosuppressive treatment before, you might already be in the middle of that process when you start Tysabri. Some sort of JC virus presence screening makes sense at any point of the therapy, if you ask me.

52. Re
    Am 10. Mai 2010 um 05:39 Uhr

    The above two posts are confusing. Where is the medical proof for these statements? What about HIV patients who get PML (there are many of them). They never had an overactive immune system. Tysabri lowers the immune system and allows the JC virus to proliferate.

53. rdo
    Am 10. Mai 2010 um 10:25 Uhr

    That’s pretty much what I said.

54. Jacque Littleford
    Am 10. Mai 2010 um 21:33 Uhr

    I am currently being evaluated for lupus (to add to my present MS status). The doctor is talking about adding plaquinel (a malaria drug) to my long list of medications. Tysabri experts taken have a non-commital stance on this. Any thoughts out there?

55. Alexander Otto
    Am 14. Mai 2010 um 20:35 Uhr

    Now there have been 49 confirmed cases of PML worldwide. More information when availabel.

56. joe
    Am 15. Mai 2010 um 07:43 Uhr

    Biogen: total 49 pml cases as of May 6
    see

57. joe
    Am 15. Mai 2010 um 19:32 Uhr

    http://www.investorvillage.com/smbd.asp?mb=160&mn=415215&pt=msg&mid=9006967

    Mean and 95% confidence interval is as follows:
     
    All Post Marketing 0.70 (from 0.67 last month)
     >=12 Infusions 1.14 (from 1.10 last month)
     >=18 Infusions 1.32 (from 1.27 last month)
     >=24 Infusions 1.62 (from 1.59 last month)
     >=30 Infusions 1.47 (from 1.53 last month)
     >= 36 Infusions 0.82 (from 0.94 last month)

58. Alexander Otto
    Am 15. Mai 2010 um 19:51 Uhr

    Thanx for doing my work Joe!

59. joe
    Am 15. Mai 2010 um 20:35 Uhr

    @Alex
    Oh..Thank you! I must tell you I enjoy so much visiting your site: accurate and informative and valuable for MS patients. Your work is excellent.

60. Remy
    Am 16. Mai 2010 um 06:42 Uhr

    Regarding the chart above, I’m assuming the number 1.14 means 1.14 out of 1,000 will get PML between 12 and 18 months? If that’s the case, the risk for 24-30 infusions is quite scary now. 1.62??

    And I think I recently read somewhere that there are about 56,000 people on Tysabri now with 67,000 total having tried it. 49 cases of PML seems like a lot. I remember when I started Tysabri there had been no post-marketing cases yet. So since I have been on the drug we have gone from zero to 49. I will be getting off of it soon. The risk is starting to seem too great for me..

61. Ernest Kaiser
    Am 16. Mai 2010 um 20:53 Uhr

    49 out of 56,000 is such a small number as to be skewed by several possibilities. One for example is mis-dx of MS when it is PML from the onset. I have no doubt that some, if not most of these cases are purely PML. Anita Smith comes to mind.

62. Katherine
    Am 17. Mai 2010 um 16:27 Uhr

    In response to Ernest:

    “In its 2005 Annual Report, Elan Inc. informed shareholders that it had entered into settlement talks with the lawyers representing Anita Smith’s estate. When contacted, Jerry Parker, the managing partner of Parker Waichman Alonso LLP said the Anita Smith Tysabri (T) case had been resolved, but that the case was confidential.”

    I have read numerous comments on T discussion boards from T users that most, if not all lesions have disappeared on recent MRIs of their brain and spine. It was the Anita Smith case it was originally claimed that after autopsy. It appears now that the reason her MS lesions were no longer there was because they had been destroyed by the T which had taken over her brain and replaced those lesions with the opportunistic infection which killed her just a few months later. Biogen bought her husband’s silence.

63. Katherine
    Am 17. Mai 2010 um 16:29 Uhr

    PML is not the only brain disease you should be concerned about if you are on or are considering starting on Tysabri, I recommend you read about the Tofanelli case in the following link:
    http://blogs.wsj.com/health/2008/08/07/legal-battle-over-tysabri-stays-in-mass-court-for-now/tab/article/
    “A spokeswoman for Biogen Idec said, “Our thoughts and sympathies go to the family.” But she added that Tofanelli died more than three months after receiving a single dose of Tysabri.”

    If the links I have already posted do not scare you, this should.
    http://en.wikipedia.org/wiki/Paul_Ehrlich
    http://en.wikipedia.org/wiki/Blood-brain_barrier
    http://en.wikipedia.org/wiki/Dr._Ehrlich%27s_Magic_Bullet
    “The joy of discovery is short-lived, as 38 patients who receive the treatment die”

64. Remy
    Am 17. Mai 2010 um 21:32 Uhr

    I don’t trust information from wikipedia citations. Give me something legitimate.

    Tysabri hasn’t made my brain lesions disappear. Personally I don’t see much talk of that in forums– mostly I hear the “no new lesions” report.

    I did recently read that 1% of organ transplants get PML. So clearly it is the immunosuppressive effect of these drugs causing the problem.

    I will miss Tysabri as I love it. But the risk/benefit ratio has reached a tipping point for me personally.

65. Katherine
    Am 18. Mai 2010 um 00:36 Uhr

    Remy, this is a Harvard Medical School link.

    http://synapse.neurology.unc.edu/rome/PowerPoint%20Presentations/Koralnik/PML%20in%20HAART%20era%20Rome%2005.ppt

    Slide 18 is referring to the Anita Smith case.

    I have SPMS and I am on Betaseron and having steroid infusions. I have improved a lot, but I’ve still got a long way to go. I have gone from needing a walker and a wheelchair to being able to get around with a cane although I did have to use a walker again to be able to function in the NY winter after moving here from CA.

    Remy, I hope you do not have permanent damage from the Tysabri, but you are making a wise decision to stop. As I am sure you already know, the recommendation for people stopping Tysabri is go go on one of the interferon drugs and steroids which is exactly what I am doing now although I would never touch any drug such as Tysabri that messes with the blood brain barrier.

66. Remy
    Am 18. Mai 2010 um 19:38 Uhr

    Based on everything I’ve read, I highly doubt I have permanent damage from Tysabri. I’ve been very happy with Tysabri and I will miss it. I cannot tolerate any of the other drugs. My doctor and I are waiting for fingolimod (now called Gilenia). He said he would not recommend Cladribine given the high cancer risks.

67. Katherine
    Am 19. Mai 2010 um 00:45 Uhr

    http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1309

    Remy, I looked up Fingolimod/Gilenia (link above). Just like Tysabri, this drug crosses the blood brain barrier which is way out of my comfort zone and is not something I would recommend to anybody else.

    http://www.drugs.com/pro/cladribine.html

    I just read this link regarding Cladribine and although I did not read the whole thing thoroughly, I read more than enough to agree that the risks are too high.

68. chicca
    Am 19. Mai 2010 um 17:10 Uhr

    Someone know how many people have made more of 36 infusion? thanks

69. chicca
    Am 19. Mai 2010 um 19:00 Uhr

    Jemand weiß, wie viele Leute haben mehr von 36 Infusionslösung hergestellt? Dank

70. joe
    Am 19. Mai 2010 um 19:45 Uhr

    @chicca
    Roughly 7000

71. Lee
    Am 20. Mai 2010 um 00:16 Uhr

    I was in the Phase III study with Avonex. I received 36 infusions before it was taken off the market in Feb “06. When it became available again (can’t remember exactly, I started up again without the Avonex and stopped in October “09. I think it was more than 36 infusions. I had no problems with the long-term Tysabri infusions; I just got cold feet after so long on the therapy. I’m back on Avonex now.

72. Ru Smolikova
    Am 22. Mai 2010 um 12:49 Uhr

    Dr. Karl Vass from Wienna has recently komfirmed the first PML patient in Austria (he had a lecture in Prague, Czech republic) – 52nd case in the table above!

73. Alexander Otto
    Am 16. Juni 2010 um 17:02 Uhr

    There are two further cases. A german patient suffering after 44 months and an us-american after 38 doses. Big shit again!

74. joe
    Am 16. Juni 2010 um 20:22 Uhr

    Biogen Idec updates Tysabri PML cases as of June 7

    Total PML cases: 55 vs 49 as of the May 6 update

    US: 20 vs 19
    EU: 32 vs 27
    ROW: 3 vs 3

    Deaths due to PML: 11 vs 11
    The overall PML rate is now 0.77 per 1,000 patients, from 0.70
    The PML rate for patients on the drug for 2 years or more is 1.76, from 1.62

75. Huri Tursan
    Am 7. Juli 2010 um 15:02 Uhr

    How is the total number of infusions counted? D

76. Alexander Otto
    Am 14. Juli 2010 um 13:46 Uhr

    Bad News

    There are three further cases:
    6/23 2010 Swiss female 52 No. 56
    7/2 2010 USA female 48 No. 57
    7/2 2010 USA male 59 No. 58

    Sorry …

77. Alexander Otto
    Am 16. Juli 2010 um 08:19 Uhr

    NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) disclosed three more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 58 as of July 2.

    The Cambridge, Mass., biotech company reported an additional death among patients that have developed progressive multifocal leukoencephalopathy, or PML, bringing the total to 12.

78. AZErnie
    Am 16. Juli 2010 um 22:01 Uhr

    Katherine “It appears now that the reason her MS lesions were no longer there was because they had been destroyed by the T which had taken over her brain and replaced those lesions with the opportunistic infection which killed her just a few months later.” There has been nothing shown that contradicts AS had a pml infection, not ms.
    Apparently you have no idea how Tysabri works, it ‘destroys’ nothing, nor does it cross the bbb, it attaches to the immune cells thought to be responsible for MS.
    It’s action is anti-inflammatory by inhibiting these immune cells attack within the brain area.
    For everyone reading these posts, check them all with RELIABLE sources. Many people here, post bad information, probably inadvertently.

79. Katherine
    Am 17. Juli 2010 um 00:49 Uhr

    AZErnie, I know that not everything I have posted is correct. After much searching, I did find ONE link from June 2010 which said that Tysabri patients have in fact given birth. That is not the issue you addressed, but I will post this link from the NMSS society and hopefully you can explain this to me:

    http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/medications/natalizumab/index.aspx

    “Tysabri is a laboratory-produced monoclonal antibody. It is designed to hamper movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier” into the brain and spinal cord.”

80. Huri Tursan
    Am 17. Juli 2010 um 14:30 Uhr

    After 18 infusions of T, I stopped it for 7 months after which a relapse led my neuro to put me back on it arguing that 7 months of T holiday meant that I was starting from scratch and I have many months ahead of me before I should start worrying again about pml! I am not very convinced. Any further ideas about how counting of infusions goes ?

81. The Good Greek
    Am 21. Juli 2010 um 15:34 Uhr

    Katherine misrepresents how Tysabri works and is on a personal mission to bash Tysabri at every turn. She was a frequent blogger on the Travis MS blog and droned on, constantly repeating herself, over and over, again and again, about the dangers of Tysabri, without ever considering the benefits. What is more, she is not a Tysabri user and is not even considering its use. Yet, she beats the drum focusing on the negative. She now admitrs that “not everything [she has] posted is correct….” Well…then don’t post false information. I just finished infusion number 28. Two of my infusion center mates are on infision 52 and 54. I know that the risks are real and significant. But, I do not need a Tysabri basher who does not use Tysabri and is not even considering it to assist in trying to bring my world down. Good luck to all Tysabri users and those who are considering it.

82. Alexander Otto
    Am 23. Juli 2010 um 15:19 Uhr

    A new case report suggests that natalizumab-associated progressive multifocal leukoencephalopathy (PML) may be successfully treated in a patient with multiple sclerosis, if caught early.

    This differs from the course of PML in other conditions, point out investigators led by Alexandra Schröder, MD, from Ruhr-University in Bochum, Germany. In the case of PML after depleting monoclonal antibodies, irreversible cellular effects are associated with very high mortality.

    Specialists Explore Options for Treating Natalizumab-Associated PML

83. Alexander Otto
    Am 19. August 2010 um 08:29 Uhr

    Bad News
    There are five further cases confirmed via wallstreet-journal.

84. Alexander Otto
    Am 27. August 2010 um 08:17 Uhr

    Preliminary Data in Support of Investigational Anti-JCV Antibody Assay Published in the Annals of Neurology
    
    The study was undertaken to develop an enzyme-linked immunosorbent assay (ELISA) to detect JCV-specific antibodies in MS patients and to evaluate its potential utility in identifying patients at higher or lower risk of developing PML.

    [ ...] A two-step assay for detecting and confirming the presence of anti-JCV antibodies in human serum and plasma was developed and demonstrated to be both sensitive and specific. ELISA cutpoints were statistically established using plasma and serum samples obtained from a total of 831 patients with relapsing MS from the STRATA study. STRATA is an open-label, single-arm, multinational study in which all patients receive TYSABRI every four weeks for 48 weeks. Subsequently, the assay was used to determine the presence of anti-JCV antibodies in TYSABRI-treated PML patients where serum samples were collected 16-180 months prior to the diagnosis of PML.

    In the evaluation, 53.6 percent of MS patients in the STRATA study tested positive for anti-JCV antibodies, with a 95 percent confidence interval of 49.9 to 57.3 percent. The false-negative rate was calculated as 2.5 percent. Notably, all pre-PML serum samples from 17 TYSABRI-treated patients who were later diagnosed with PML were anti-JCV antibody positive. This was significantly different from the 53.6 percent seropositivity observed in the analysis of the STRATA study (p<0.001).

    The article, entitled “Anti-JC Virus Antibodies: Implications for PML Risk Stratification,” can be found online and will be published in the Annals of Neurology September print issue, Volume 68, Issue 3.

85. Alexander Otto
    Am 27. August 2010 um 08:24 Uhr

    The Fall of Tysabri?
    An article in Dow Jones Newswires states “Deutsche Bank analyst Robyn Karnauskas recently projected that Tysabri’s patient discontinuation rate, currently 2% to 3%, will skyrocket when oral therapies are available. She projects 20% of patients on the drug will stop using it in 2011 and 25% in 2012.”

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