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Thread: TOTAL PML CASES in MS PATIENTS ON TYSABRI

  1. #11
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    Don't they release info once a month on the financial pages? I think we have found it in the past there and it really p***ed us off. Maybe it has changed. It certainly is not the detail that is some times reported here.

    ANN
    There comes a time when silence is betrayal.- MLK

  2. #12
    Distinguished Community Member agate's Avatar
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    Ann, for years I've had a Google e-mail alert letting me know about any news about Tysabri and PML. The information usually came through the financial pages. In the last several months or more, there has been almost no reporting of Tysabri-related PML cases in the media.

    Or if there is, Google isn't finding it.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
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  3. #13
    Distinguished Community Member Frog42's Avatar
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    I searched and came up with this: http://www.medscape.com/viewarticle/744137

    Looks like you can get free access to Medscape if you want to sign up. Reuters hasn't had any updates since Feb. Some others haven't had any updates for several years. Hope this isn't too long.

    Update Shows Higher Incidence of Natalizumab-Associated PML

    Kate Johnson


    June 7, 2011 (Montreal, Quebec) — Numbers are higher than previously reported for the postmarketing incidence of progressive multifocal leukoencephalopathy (PML) associated with the use of natalizumab (Tysabri, Biogen Idec), according to an update presented here at the Consortium of Multiple Sclerosis Centers 25th Annual Meeting.

    As of May 2011, there have been 124 reported cases of natalizumab-associated PML worldwide among 83,300 patients treated for multiple sclerosis (MS), said John Foley, MD, from Rocky Mountain Multiple Sclerosis Clinic, in Salt Lake City, Utah, and a consultant for the company.

    That is an overall incidence of 1.4 cases per 1000 patients — an increase from the 1.2 per 1000 rate announced by the US Food and Drug Administration (FDA) and reported by Medscape Medical News in April.

    Rare Opportunistic Infection

    Natalizumab was first approved by the FDA in 2004 to treat relapsing forms of MS but was temporarily withdrawn from the market the following year because of its association with PML — a rare opportunistic infection of the central nervous system infection caused by the John Cunningham virus (JCV).

    The drug was reintroduced in 2006 with stricter safety warnings and monitoring recommendations, and this spring, labeling was updated to quantify postmarketing PML incidence rates according to duration of exposure.

    Now, a further update presented at this meeting shows the highest PML incidence continues to be in patients who have received 2 to 3 years of monthly natalizumab infusions — in whom there is a current PML rate of 1.89 cases per 1000 patients, up from the previously reported 1.5 cases, reported Dr. Foley.

    In contrast, patients who have received between 3 and 4 years of infusions continue to have a lower incidence, at 1.10 cases per 1000 — up from 0.9 cases.

    "We're, of course, very interested in what's happening here," commented Dr. Foley. "Is this real or a statistical artefact? We still have small numbers of patients out in this range."

    Finally, the lowest PML rates continue to be in patients who have received 2 years or less of monthly infusions, in whom the most recent incidence is 0.49 cases per 1000 patients — up from 0.3 cases, he said.

    "Clearly, the statistics are suggesting that the longer you're on the drug, the higher the risk. It also looks like there's a more definitive association being established with prior immunosuppressant therapy. And, we now have, probably what you might call a secondary risk stratification factor — that being the JCV antibody — [for which a screening test] is currently completing its experimental phase and will likely move into a commercial phase most likely this year."

    JCV Antibody

    According to company data, all cases of PML in which anti-JCV antibody status had been determined at least 6 months before symptom onset have been antibody positive, said Dr Foley.

    In a subset of 79 such cases (median follow-up, 9.3 months from symptom onset), prior exposure to immunosuppressant therapy and longer duration of natalizumab exposure also appeared to confer a greater risk.

    Among patients with anti-JCV antibody positivity and up to 2 years of monthly infusions, the incidence of PML was 0.35 cases per 1000 in those without prior immunosuppressant exposure, compared with 1.2 cases per 1000 in those with prior immunosuppressant exposure.

    Similarly, among antibody-positive patients with up to 4 years of monthly infusions, the incidence of PML was 2.5 cases per 1000 among those without prior immunosuppressant exposure and 7.8 cases per 1000 in those with prior immunosuppressant exposure.

    "Obviously, this is of significant concern, and I think the majority of practitioners are moving to rearrange this [latter] category as far as therapeutics," he said.

    Among the 79 cases there has been a 20% mortality rate, "which is significantly lower than in the HIV population and might suggest that patients with normally functioning immune systems do better with PML," noted Dr. Foley. The median time from diagnosis to death was approximately 2 months.

    However, among those patients who have survived with at least 6 months of follow-up, most (87%) rate moderate to severe on the Karnofsky Performance Status Scale.

    "Usually, patients look fairly encephalopathic, there are changes in behavior and personality, there's often times motor paresis, usually hemiparesis, language disturbance is very common, and visual field defects are very common. [Magnetic resonance imaging] usually shows nonenhancing T2 lesions...and usually the JCV DNA cell counts are fairly low — reemphasizing the fact that a high-sensitivity assay really needs to be done if there's a suspicion of the disease," he said.

    Despite treatment with either plasma exchange or immunoadsorption, "the vast majority" of patients developed immune reconstitution inflammatory syndrome usually by 4 weeks after diagnosis, he added.

    PML survival appears to be associated with rapid diagnosis and treatment, as well as younger age — with the average age of patients with fatal cases being 52 years compared with 43 years in the patients with nonfatal cases, he reported.

    In addition, localized unilobar disease had the lowest mortality rate (12.5%) compared with multilobar disease (25%), with widespread disease carrying a 63% mortality rate.

    "Clearly, clinical vigilance is very important — we have hope that the JC antibody will help us as a stratification measure, and we continue to look at and hopefully define some further secondary and tertiary risk stratification measures to better manage natalizumab in this patient population," said Dr. Foley.

    No Cause for Complacency

    Although JCV antibody status appears to be associated with PML risk, it is premature to rely too heavily on it, based on retrospective data, warned Mark S. Freedman, MD, professor and director of multiple sclerosis research at the University of Ottawa, in Ontario, Canada.

    "They have yet to find someone who had PML that did not have antibody positivity — but not everyone who had PML had an antibody test done," he explained to Medscape Medical News.

    What I'm against is people saying it's a 'fait accompli' that if this test is negative you have no risk. Based on retrospective data you probably have a lower risk, but is it zero?

    "The big question is, if you're antibody negative does that assure you 100% safety? The retrospective data suggest this might be true — but now they need to look prospectively. What I'm against is people saying it's a 'fait accompli' that if this test is negative you have no risk. Based on retrospective data, you probably have a lower risk, but is it zero? How high is that risk? We don't know."

    In addition, although the data show an 80% survival rate, this comes at a price, he said. "This is a miserable disease. If you got it, you'd probably rather be dead because there's no treatment for it — it destroys brain tissue. Eighty percent to 90% of people are highly disabled if they survive PML."

    And although the latest figures suggest a slight downturn in incidence after 3 years of treatment duration, Dr. Freedman says this is no cause for complacency.

    "I think the fall-off was really that people started getting cold feet about leaving people on it for 3 or 4 years, so the incidence went down because they took patients off it," he said. "Now it's going back up because they were all reassured. We've now got the data from 48 to 72 months and it's back up again."

    Dr. Foley declared consulting fees from Biogen Idec, Genzyme, and Teva and honoraria from Biogen Idec and Teva. Several of the study's coauthors are Biogen Idec employees. Dr. Freedman declared consulting fees from Biogen Idec, Bayer HealthCare, Celgene, Sanofi-Aventis, Novartis, Merck Serono, and Genzyme. Dr. Freedman is also an uncompensated member of the editorial advisory board for Medscape.

    Consortium of Multiple Sclerosis Centers (CMSC) 25th Annual Meeting: Abstract P15. Presented June 2, 2011.


    Whatever happens around you, don't take it personally. Nothing other people do is because of you. It is because of themselves. -- Miguel Ruiz

  4. #14
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    Agate & Vicky - we had the mid-July post about the first US PML case w a negative JC test here:http://www.reuters.com/article/2011/...7IF0CZ20110715

    We later found out that there was a ? as to whether the test was given after the wash out <what is that called> had started.

    I can't find anything in August. _ANN
    There comes a time when silence is betrayal.- MLK

  5. #15
    Distinguished Community Member agate's Avatar
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    This is from the archived board and included data from May through July:

    http://www.braintalkcommunities.org/...=108876&page=2

    Here is ANN's July 27 thread from the archived board about the patient who developed PML in spite of a negative test for the JC virus:
    http://www.braintalkcommunities.org/...d.php?t=117127

    And this (from this new board) gives data for August:

    http://www.braintalkcommunities.org/...-total-now-150
    Last edited by agate; 09-10-2011 at 08:13 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  6. #16

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    Sorry I'm late to the thread. I didn't have time this weekend to respond.

    There are three sources for PML cases that I consider to be accurate enough to pass on to other people because the cases are verified:

    http://www.nationalmssociety.org/new....aspx?nid=2308

    And calling 1-800-456-2255. This is Biogen and they will be more than happy to speak to people using Tysabri and nonusers of Tysabri. They don't want any false information floating around but will be happy to talk with anyone about the verified cases.

    And, last but not least, your doctor will have this information handy. If you are a medical professional go to http://medinfo.biogenidec.com/] to get this information.


    For those of you on Tysabri, I wish you the very best. It's been miraculous for me. I tested postitive for the JC virus and I plan to stay on it.
    Last edited by JTwin; 09-12-2011 at 06:51 AM. Reason: correction for URL

  7. #17
    Distinguished Community Member agate's Avatar
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    Thanks, JTwin! It's helpful to know that the information is still generally available.

    The MS Society page was last updated on August 22 and shows a total of 150 PML cases.

    Calling Biogen's number, I was given information as of August 4: 150 confirmed cases of PML but 1 of them is a Crohn's disease patient. As of August 4, there have been 29 deaths due to PML related to Tysabri.

    So we're really talking about 149 PML cases in people with MS taking Tysabri--or 156 cases if we're looking at the chefarztfrau Website data.

    They get updated information around the middle of the month, and I was encouraged to call back later this month.

    I was also told that as of June 30, 2011, a total of 88,100 persons have received Tysabri.

    Of the 150 PML patients, 46 are men, 104 women. In the US there have been 58 cases, and Europe has had 85 cases. The rest of the world has had 7 cases.

    The number of Tysabri doses the patients had before developing PML varied between 8 and 54.
    Last edited by agate; 09-12-2011 at 08:32 AM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
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  8. #18
    Distinguished Community Member agate's Avatar
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    According to BiogenIdec, the total number of PML cases worldwide as of September 1, 2011, is 159.

    The data for October should be available in a couple of weeks.

    I've asked the moderators if this thread title could be changed to TOTAL PML CASES IN MS PATIENTS ON TYSABRI.
    Last edited by agate; 10-14-2011 at 09:30 AM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
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  9. #19
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    Chefarztfrau now shows 170 cases....

  10. #20
    Distinguished Community Member agate's Avatar
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    Thanks for pointing this out, ULOOKFINE. If you've read through this thread, you may have noticed a feeling that chefarztfrau isn't "official" and therefore its data are open to question.

    Over several years now the chefarztfrau figures haven't been wrong....

    WELCOME to this board! Why not post some more and tell a little about yourself?
    Last edited by agate; 10-14-2011 at 01:58 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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