Friday, March 18, 2011

7 More PML Infections and 1 More Death in Tysabri Patients; 102 Total PML/Tysabri Patients (March 2011)

This morning I woke up very early cause I had to make my way the hospital for my Rituxan infusion.  Very proud of myself that I was actually up early and could check some email before leaving.  I happened to check my blog stats and noticed that someone at BiogenIdec had been reading my blog posts related to Tysabri/PML patients.

Hmmm, what was going on over at Biogen I thought?  So I conducted a search for newly reported cases of PML and found nothing.  I lurked over at cafepharma and saw that a couple of (anonymous) people were discussing a new total of 102 cases.  I searched for news announcements on Twitter.....nothing came up.  So I left a quick thought around 6am.

After returning home late this afternoon, I find that indeed a brief Nasdaq article had been published this afternoon.  The first version was pulled within 10 minutes (before I could read it) but a corrected version quickly took it's place.  The correction can be found below.

Out of 102 reported cases to date, 42 (41%) have occurred in the United States, 55 (54%) occurred in Europe, and 5 (5%) were elsewhere in the world.  The total number of deaths in the 102 cases is 21 patients representing a 20.6% death rate amongst those Tysabri patients diagnosed with PML (progressive multifocal leukoencephalopathy).

CORRECT: Biogen Reports 7 More Infections In Tysabri Patients

("Biogen: 7 More Infections, 1 More Death In Tysabri Patients," at 4:09 EDT, misstated the regional distribution of cases in the eighth paragraph. The correct version follows:)

By Thomas Gryta

NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) reported seven more cases of a rare brain infection among multiple-sclerosis patients taking Tysabri, sold with Elan Corp. (ELN) bringing the total number of affected patients to 102 as of March 4.

The Weston, Mass., biotech company reported that one more of those patients has died, bringing total deaths to 21. The cases of the infection--known as progressive multifocal leukoencephalopathy, or PML--are closely watched as the MS market becomes increasingly competitive.

The drug is generally regarded as highly effective, but mostly used for patients that have stopped responding to other drugs or have aggressive cases of the disease.

Biogen recently halted enrollment in a major clinical trial aimed at testing the earlier use of Tysabri, citing a slower-than-expected pace of finding participants and the desire to devote resources toward "risk stratification" efforts for the drug.

Biogen is developing a blood test that may better determine the chances of patients contracting PML. The test recently received CE Mark approval in Europe and the companies are conducting large studies of its effectiveness.

Regulators have said that they monitor cases of PML as they occur and have concluded that the benefits of the medicine outweigh the risks. Tysabri was withdrawn from the market in 2005 and relaunched in 2006--because of its effectiveness--with a strict access plan that monitors patients.

The overall global PML rate is now at 1.23 per 1,000 patients. A Biogen spokeswoman said the current PML figure is "still generally within what we saw in clinical trials."

Of the total PML cases, 42 were in the U.S., 55 were in the European Union and five in other areas.

The risk of the infection generally increases with the number of monthly infusions that a patient receives, but that rate appears to drop after 30 months. Biogen is studying this drop and warns there is limited information from patients on the drug longer than 36 months.

The most-recent data translate to a rate of 1.87 cases per 1,000 patients on the drug for a year or longer, rising to 2.41 per 1,000 for those on the drug for two years or longer, and dropping to 1.4 for more than three years.

Looked at another way, the rate is about 1.68 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.44 case per 1,000 patients in those using it for one to two years, and it is essentially nonexistent in patients using it for less than a year.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
(END) Dow Jones Newswires
  Copyright (c) 2011 Dow Jones & Company, Inc.

1 comment:

  1. I'm so glad I got off that drug! At this point I've tried them all, even chemo and i am going to stick with Copaxzone. Nicole