Living With MS

Discussing all aspects of Multiple Sclerosis, various treatments, including accurate information regarding Tysabri.

Saturday, August 02, 2008



My Tysabri Diary...time for everyone to calm down and take a deep breath...
Damage Control..., I have been receiving e-mails left and right from MS patients currently on Tysabri therapy about the two new cases of PML which were just reported by Biogen/Élan. This news of the two new cases of PML have already hit the MS boards... I'm trying to keep everyone calm until all relevant facts have been disclosed by the companies... it is noteworthy to know that these two patients are not in the US, they are in the European Union where they do not have the Touch protocol... both patients are alive, and one is already home and still ambulatory.

Tysabri is still my drug of choice to treat my MS.

The full details of these two patients prior histories has not been as yet released (i.e., were they already immune compromised before starting Tysabri therapy?)... therefore I would caution everyone to not panic and not read too much into this news until all the facts are known... from what I have been reading, most neurologists are not terribly concerned about these two cases, and the vigilance of the neurologists in the EU has to be extraordinary, considering they don't have the Touch program..., of course, some Tysabri patients will request that go off the therapy as this news is beyond their comfort level for risk vs. benefits, but the majority of MS Tysabri patients will remain intact, with still more MS patients being added weekly:

Read the news for yourself, this is from the FDA's archive files:

http://tinyurl.com/55sfod

On July 31, 2008, Biogen Idec Inc. and Elan Corporation, plc notified relevant regulatory agencies of two confirmed cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients treated with TYSABRI® in the commercial setting. Additional information about these cases is set forth below.

Case 1

· On July 30, 2008, following a period of clinical evaluation, Biogen Idec received confirmation of a diagnosis of PML in an MS patient in the European Union (EU).

· The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.

· As reported to the company on July 31, 2008, the patient remains clinically stable and ambulatory at home.

· Background:

- Patient in EU with aggressive MS who was naïve to prior disease modifying therapy;

- TYSABRI monotherapy for approximately 17 months;

- Clinical vigilance led to early identification of signs and symptoms of possible PML and medical work-up which included MRI scanning and CSF testing, but PML was not confirmed at that time;

- However, given continued clinical suspicion by treating physician, plasma exchange was initiated as outpatient;

- Subsequent testing of CSF detected JCV DNA, which was reported to the company on July 30, 2008;

- It was then determined by PML experts that the latest CSF results, together with the clinical history, physical findings, and MRI results, are consistent with the diagnosis of PML.

Case 2

· On July 31, 2008, Biogen Idec was notified of a diagnosis of PML in a second MS patient in the EU.

· The diagnosis was made based upon the detection of JCV DNA in the CSF in the setting of clinical signs, symptoms, and MRI findings consistent with the diagnosis of PML.

· As reported to the company on July 31, 2008, the patient is currently hospitalized.

· Background:

- Patient in EU with MS with a history of prior disease modifying therapies including azathioprine and beta-interferons;

- TYSABRI monotherapy for approximately 14 months;

- Evaluation for possible PML, included MRI scanning and CSF testing;

- CSF testing detected JCV DNA, which was reported to the company on July 31, 2008;

- The CSF results, together with the clinical history, physical findings, and MRI results, are consistent with the diagnosis of PML.

***
In closing, let me say that I only hope that some of the above information does help to relieve some of the fears that have been circulating… honestly, IMHO not enough is known about these two patients prior medical histories that would make them susceptible to developing PML. In addition, plasmapheresis has been used on one patient to remove Tysabri from the body, and the other patient is currently receiving plasmapheresis therapy, even though he’s in the hospital.

It is also my hope that those two patients make a full recovery as the due diligence of their neurologists paid off in that they both caught these two cases in early.

((((hugs))))

Love, Lauren :)

2 Comments:

  • At 9:31 PM, Blogger Denver Refashionista said…

    You should do what feels right to you:)

     
  • At 6:38 PM, Anonymous Anonymous said…

    Calm heads need to prevale. It will be of interest to learn more about the two patients in question. I hope more will be shared as that is how we can all be further reassured that the Touch Program is comprehensive in it's care and approach toward current Tysabri patients in the US.

    Thanks again Lauren for your cogent comments.

    Deb

     

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