Web links:
At present, I don't have a reliable link
for current information on the number of PML cases. I get information through the local Biogen medical affairs representative.
As far as I know, they are not maintaining a website with information for patients.
Biogen reports Tysabri complications to the
SEC because it is information that might affect the stock price, and to the FDA for safety reasons. As I understand
it, they do not plan to communicate to physicians or the public in general unless there is new information that would change
our opinion of the level of risk from Tysabri. Links to the SEC reports can be found online at http://www.biogenidec.com/site/tysabri-information-center.html. They are titled "Form 8-K regarding other events". Form 8-K includes investor information besides
new cases of PML, so you have to sort through some other things. Another source is http://www.biogenidec.com/tpme. This page was updated every Friday with the last update on July 24, 2009. I don't think they are planning
to issue any new updates, so it may get more difficult to get current information on the number of PML cases. I found
information on the two most recent cases on the FDA website http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm. Updates:
10/16/09 A patient treated with Tysabri for 21 months developed lymphoma in the brain. There
was no sign of the Epstein-Barr virus infection which causes some cases of lymphoma. This is a serious disease, but
this is the first case reported in association with Tysabri.
9/22/09 Two additional cases have been reported. There weren't any details
about how long the 2 new cases had been on treatment. There was one additional case in Europe and one in the US.
8/20/09 There have now been a total of 11 cases of PML
since reintroduction of Tysabri. Three new cases were reported in June and one in July. All cases have been in
MS patients, and 8 of the 11 are in Europe with 3 in the US.
There
are currently 30,600 patients on treatment for 12 months or more, 18,400 on treatment for 18 months, and 10,000 on treatment
for 2 years.
The timeline is as follows:
Date reported Months on treatment
7/30/08
17
7/31/08
14
10/29/08
14
12/10/08
26
2/5/09
12
4/15/09
31
5/18/09
24
6/10/09
35
6/19/09
34
6/23/09
30
7/24/09
29
One obvious concern is that the risk of PML may go up with longer treatment.
If this is true, then there should be an increasing number of cases over time, although it is reassuring that only one addition
case occurred in July. I will continue to monitor this situation very closely. At present I have about 15
patients on Tysabri, and all of them have pretty severe MS which makes the risk more acceptable.
2/10/09 An additional case of PML
from Europe, occurring after 12 months of treatment, was reported 2/5/09. This brings the total number of confirmed
cases to 5, with about 20,200 patients on Tysabri for over a year.
1/6/09 An additional case
of PML from Europe was reported on 12/11/08. The patient had received 26 months of Tysabri,and the diagnosis of PML was
confirmed by PCR and MRI. He presented with cognitive changes. He had previously failed treatment with interferon
and was responding well to Tysabri. His last dose was on 10/29. He was treated with immunoadsorption. His
current status is not reported.
10/30/08
An additional case of PML was reported on 10/29/08. This patient had MS since 2001, and had been on Tysabri for
14 months. Following her last dose in late September she had some worsening of her previous MS symptoms, and then developed
troubles with language in late October. Brain MRI was suggestive of PML, and JC virus DNA was detected in the spinal
fluid. The patient was treated with plasma exchange, and is back at home. She was not receiving any other
immunosuppressive medicines while on Tysabri, but she has been treated with methotrexate in the past (not for MS).
There are currently 18,000 patients that have been on Tysabri more than 12 months and 9500
that have been on treatment more than 18 months.
The
two previous cases of PML, both in Germany, (see report below), have improved, but they continue to have deficits related
to the PML.
We will continue to monitor the number of
PML cases. For now, the number of cases is small compared to the number of people on treatment. The risk
of PML seems to be acceptable for people with severe MS, and I am continuing to recommend Tysabri to carefully selected
patients. If you have any concerns, please call the office.
