6th PML Case?
- screamner
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6th PML Case?
Hello,
have anybody heard somthing about a new case, the Boston Globe ist writing somthing about it.
<shortened url>
have anybody heard somthing about a new case, the Boston Globe ist writing somthing about it.
<shortened url>
http://online.wsj.com/article/BT-CO-200 ... 13211.html
Its in the Wall Street Journal too...
*deep breath*
Its in the Wall Street Journal too...
*deep breath*
- RuSmolikova
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- 10yearsandstillkicken
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How many of those who have come down with PML since tysabri was re-introduced, have been in Europe vs the US? Seems like there have been 5 in Europe and 1 in the US. How many total in each taking tysabri? Seems like Europeans are getting this more than here in the states. Why would that be? Just seems odd to me. Maybe statistically important?
Chuck
- RuSmolikova
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- 10yearsandstillkicken
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European taking TYsabri + long term steroid therapy.
This seems quiete strange.
Here in France i've have been under Tysabri for nearly two years and heard about Tysabri added to Prednisolone only in case of relapse.
The effect of long term steroid therapy is harmful.
As well in UK(where i lived for two years before coming back to France) they prescribe as few as possible and not with Tysabri, since they do not prescribe it(due to their NHS logic: money vs health)
otherwise i've not heard on any french Ms forums about some users having any PML. and when some of them have weird effects they're straightly stopped for this medication.
This seems quiete strange.
Here in France i've have been under Tysabri for nearly two years and heard about Tysabri added to Prednisolone only in case of relapse.
The effect of long term steroid therapy is harmful.
As well in UK(where i lived for two years before coming back to France) they prescribe as few as possible and not with Tysabri, since they do not prescribe it(due to their NHS logic: money vs health)
otherwise i've not heard on any french Ms forums about some users having any PML. and when some of them have weird effects they're straightly stopped for this medication.
- RuSmolikova
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Sorry for misunderstanding - I didn´t mean Tys+steroids. All the patients in the Czech republic have an experience with long term steroid therapy (years and years of daily use of prednison or medrol + DMDs) before being switched on Tys. And I don´t know any PML case in Czech rep., at the moment.superman wrote:European taking TYsabri + long term steroid therapy.
This seems quiete strange.
BTW does anybody know where all the nonUSA cases are from? I know about two Germany PML cases and one in Sweden...
What is the top difference between TOUCH and TYGRIS programme? Frequency of MRI? More precise MRI software?
Touch program says how Tysabri must be prescribed
Tygris program observes how Tysabri patients react
(from R'uter and Tysabri websites)
TYSABRI is available only through the TOUCH Prescribing Program, which stands for TYSABRI Outreach: Unified Commitment to Health.
TOUCH is a restricted distribution program focused on safety and developed with the help of the Food and Drug Administration (FDA):
* Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI
* Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI
TOUCH offers more access to doctors and nurses. Your treatment is closely monitored to help make sure TYSABRI continues to be right for you:
* Once every month at each infusion visit
* Every 6 months by your doctor
TOUCH assigns you your own specially trained Case Manager to help:
* Get you started on therapy and answer questions about your therapy
* Find an authorized infusion site in your area
* Provide information about insurance coverage and possible sources of financial assistance, if necessary
TYGRIS (TYSABRI Global ObseRvation Program In Safety) and CD
INFORM (Crohn's Disease - Investigating Natalizumab through Further
Observational Research and Monitoring) are part of the global risk
management plan for TYSABRI. TYGRIS is expected to enroll 5,000 MS
patients worldwide, including approximately 2,000 - 2,500 patients
from TOUCH. CD INFORM is expected to enroll 2,000 Crohn's patients in
the US. Patients in TYGRIS and CD INFORM are evaluated at baseline and
every six months thereafter for five years. Researchers will evaluate
data including medical history; prior TYSABRI use; prior use of
immunomodulatory, antineoplastic, or immunosuppressive agents; and all
serious adverse events, including PML and other serious OIs and
malignancies.
Tygris program observes how Tysabri patients react
(from R'uter and Tysabri websites)
TYSABRI is available only through the TOUCH Prescribing Program, which stands for TYSABRI Outreach: Unified Commitment to Health.
TOUCH is a restricted distribution program focused on safety and developed with the help of the Food and Drug Administration (FDA):
* Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI
* Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI
TOUCH offers more access to doctors and nurses. Your treatment is closely monitored to help make sure TYSABRI continues to be right for you:
* Once every month at each infusion visit
* Every 6 months by your doctor
TOUCH assigns you your own specially trained Case Manager to help:
* Get you started on therapy and answer questions about your therapy
* Find an authorized infusion site in your area
* Provide information about insurance coverage and possible sources of financial assistance, if necessary
TYGRIS (TYSABRI Global ObseRvation Program In Safety) and CD
INFORM (Crohn's Disease - Investigating Natalizumab through Further
Observational Research and Monitoring) are part of the global risk
management plan for TYSABRI. TYGRIS is expected to enroll 5,000 MS
patients worldwide, including approximately 2,000 - 2,500 patients
from TOUCH. CD INFORM is expected to enroll 2,000 Crohn's patients in
the US. Patients in TYGRIS and CD INFORM are evaluated at baseline and
every six months thereafter for five years. Researchers will evaluate
data including medical history; prior TYSABRI use; prior use of
immunomodulatory, antineoplastic, or immunosuppressive agents; and all
serious adverse events, including PML and other serious OIs and
malignancies.
- 10yearsandstillkicken
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Seems like each program should be combined. That is probably the reason why more Europeans have been found with pml. Tygris looks for reaction while touch may not? The questionnaire (touch) prior to infusion asks if there have been any changes as well as if any medications have been taken. Anyone know how many Europeans are currently on tysabri vs how many in the states?
Chuck
- RuSmolikova
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Biogen says on its website:10yearsandstillkicken wrote:Anyone know how many Europeans are currently on tysabri vs how many in the states?
"As of the end of March 2009:
• Approximately 40,000 patients were on TYSABRI therapy worldwide; of these:
- In the U.S., approximately 20,800 patients were on TYSABRI therapy
commercially;
- In the rest of world, approximately 18,500 patients were on TYSABRI therapy commercially; and
• In global clinical trials, approximately 600 patients were on TYSABRI therapy."