I spoke to Dr. Vollmer about Tysabri yesterday - Stan
I asked him to write me an email outlining what we spoke about...
Here is a copy of the email that I found in my "inbox" this morning....stan
Dear Stan,
As you know, it has been recently reported that two more patients on Tysabri have been diagnosed with PML.
As you remember, PML is a viral infection of the brain that occurs when the immune system is not able to enter the brain to clear the virus.
Since we all carry this virus naturally, anyone on Tysabri may be a risk for this.
The recent cases occurred after only 14 months and 18 months of exposure to Tysabri alone.
This confirms in my mind that it is due to Tysabri and not some interaction with other medications.
There are over 28,000 MS patients on Tysabri at this time with almost half with more than one year of exposure.
Overall the risk of PML with use of Tysabri is not different from what I discussed with you in the past, but it is not better either.
At this time, we do not yet know how the FDA will respond. But in that both of these recent cases were found at a relatively early stage and the drug has been stopped (and in one case plasmapheresis performed) we need to see if the PML is stopped and how much in the way of new neurological symptoms persist in these patients. This will take several months.
Therefore I would recommend the following:
1. If a patient on Tysabri has any new neurological symptoms, Brain MRI should be performed.
2. If the brain MRI has any suspicious lesions, the Tysabri should be stopped and the patient should have the appropriate spinal fluid and blood tests to look for evidence of PML.
3. If the patient has been on Tysabri for around two years, they may want to consider stopping the Tysabri and restarting Copaxone, Rebif, Betaseron or Avonex with close monitoring clinically and by MRI to detect any reactivation of MS. This later point will be controversial and I may change the recommendation in the future.
Please keep in mind that stopping Tysabri within the first year of treatment may result in a rebound effect with increased activity of the MS.
Whatever patients on Tysabri decide to do they should definitely consult their physicians first and work closely with them in managing this drug.
As more information emerges, we will need to rediscuss this issue.
Please let me know if you have questions.
Best Tim
Timothy L. Vollmer, MD
Professor Department of NeurologyUniversity of Colorado Health Sciences Center
and Medical Director, Rocky Mountain MS Center
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