The two biggest changes from the new Tysabri prescribing information appear to be:
1. Tysabri is no longer considered a 2nd-line therapy. It can now be prescribed at the initial DMT for fighting MS. This falls in line with those who believe you should hit MS 'fast and hard' with more aggressive treatments to limit the amount of damage done. You should discuss all treatment options with your neurologist. There is also benefit in getting a 2nd opinion from a qualified neurologist/MS specialist.
2. For JCV- patients, the risk is considered <1/1,000 independent of the length of time on Tysabri. Please remember you can switch from JCV- to JCV+ at any testing interval so ensure you are being tested. There was a small study suggesting the test may also generate some false-negatives. The Biogen stated false negative rate is 3%.
For JCV+ patients, the risk increases with the length of time on Tysabri and whether you have had prior immunosuppressant use.
JCV+ with NO prior immunosuppressant use:
JCV+ with prior immunosuppressant use:
*Please remember there is very limited information past the 48 month time frame.
There are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI will mitigate the disease. PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for at least six months following discontinuation of TYSABRI.
- Tysabri can now be considered a first-line therapy.
- PML saftey information and statistics have been expanded from a maximum of 4 to a maximum of 6 years.
1. Tysabri is no longer considered a 2nd-line therapy. It can now be prescribed at the initial DMT for fighting MS. This falls in line with those who believe you should hit MS 'fast and hard' with more aggressive treatments to limit the amount of damage done. You should discuss all treatment options with your neurologist. There is also benefit in getting a 2nd opinion from a qualified neurologist/MS specialist.
2. For JCV- patients, the risk is considered <1/1,000 independent of the length of time on Tysabri. Please remember you can switch from JCV- to JCV+ at any testing interval so ensure you are being tested. There was a small study suggesting the test may also generate some false-negatives. The Biogen stated false negative rate is 3%.
For JCV+ patients, the risk increases with the length of time on Tysabri and whether you have had prior immunosuppressant use.
JCV+ with NO prior immunosuppressant use:
1-24 months < 1/1,000
25-48 months 3/1,000
49-72 months 7/1,000*
25-48 months 3/1,000
49-72 months 7/1,000*
JCV+ with prior immunosuppressant use:
1-24 months 1/1,000
25-48 months 13/1,000
49-72 months 9/1,000*
25-48 months 13/1,000
49-72 months 9/1,000*
*Please remember there is very limited information past the 48 month time frame.
There are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI will mitigate the disease. PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for at least six months following discontinuation of TYSABRI.
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