Saturday, 14 January 2012

Nataluzimab PML Update: 193 cases as of 1st December

As Prof G has forgotten his update and January's will be here soon

Status of MS'ers with PML as of 1st December, 2011
:
  • 193 PML cases, of which 112 have been in the European Economic Area (EEA), 71 in the US and 10 in rest of world (ROW).
  • 39 of the 193 (20%) patients with PML have died.

MS patients who developed PML and in whom serum samples were available 6-187 months prior to the onset of PML, all 45 patients had anti-JCV antibodies detected.

Samples were available from 73 patients at the time of PML diagnosis and all 73 tested positive for anti-JCV antibodies.

CoI: Data in this post has been supplied by Biogen-Idec as part of their "monthly natalizumab safety update and PML risk stratification programme".

6 comments:

  1. As a Tysabrian (and JCV+) due to have my 34th infusion this week, I am frustrated at the paucity of meaningful analyses on PML treatment that is reported.

    By that I mean : Are the ratios of death / severe disability / moderate disabilty changing over time and/or do they vary across countries ? Have any triggers for the condition been suggested and investigated ? Is the management of IRIS improving ? Are those patients who (very sadly) die people in whom the JCV starts the PML process and progress quickly to death or patients who were diagnosed with PML some time ago and acquire other infections that prove fatal ?

    Is this type of analysis available to neurologists - and if not, why not?

    I accept the risk / benefit equation in personally continuing with Tysabri but would hope that both positive and negative lessons learned would be shared amongt the people I will be relying on to treat me if the JCV does its worst.

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  2. Re: "Tysabrian"

    We would prefer you to use the name Natalizian; it is considered poor form to use Trade names in academia.

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  3. Re: "Are the ratios of death / severe disability / moderate disability changing over time and/or do they vary across countries?"

    Yes, the mortality (death rate) is improving with earlier diagnosis and management. There are too few cases to allow comment on outcome at this stage or across countries. Most countries have had very few cases.

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  4. Re: “Have any triggers for the condition been suggested and investigated?”

    Yes. The main trigger is previous exposure to immunosuppressive therapies and duration of exposure to natalizumab (>24 months). And of course the presence of the virus, that is previous exposure as detected by having antibodies in your blood to the virus.

    The following is a list of previous immunosuppressives that have been linked to natalizumab-associated PML: mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab.

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  5. Re: “Is the management of IRIS improving?”

    Yes. The prognosis, in terms of survival has been improving. Most clinicians now use steroids to manage the IRIS. Overall 10% of PML survivors have mild disability, 50% moderate disability and 40% severe disability.

    It is clear that PML is associated with a poor outcome in the majority of MS’ers who develop this complication.

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  6. Re: “Are those patients who (very sadly) die people in whom the JCV starts the PML process and progress quickly to death or patients who were diagnosed with PML some time ago and acquire other infections that prove fatal?”

    The vast majority of these people sadly die from having PML and not from other complications.

    The following are factors that have been associated with a poor prognosis; (1) older age at PML diagnosis, (2) higher pre-PML EDSS, (3) longer time from first symptoms of PML to diagnosis and (4) widespread PML extension on MRI at diagnosis.

    The following factors are not linked to prognosis; (1) gender, (2) prior immunosuppressant therapy, (3) MS duration, (4) duration of natalizumab exposure at PML diagnosis, (5) amount of JCV virus in the spinal fluid at PML diagnosis and (6) the presence of Gd-enhancement on MRI at diagnosis. The latter is a sign of IRIS.

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