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One Response to 'Tysabri Clinical Trials Halted for Rheumatoid Arthritis Posted By : Rex Magnum'

1. Lauren - May 29th, 2008 at 2:55 pm

   Dear Mr. Magnum:

   As a MS patient for over 32 years, and a Tysabri patient that has had 21 infusions of Tysabri are so far, I felt the need to comment on your article about the Tysabri Clinical Trials…, and for the most part, much of the information presented there is correct, with the exception of the following on the continuing page (page 2 of the article):

   Patient must have a strong immune system.
   Tysabri must be taken without additional immunosuppressant drugs.
   No other drug will work for the patient.
   Registered infusion centers alone could administer Tysabri.
   Doctors must enroll in the TOUCH program in order to prescribe Tysabri.

   You indicated that “No other drug will work for the patient.”… This is incorrect. In MS patients, Tysabri can be used as a first-line or a second-line therapy, especially when the MS patient has a very aggressive form of MS such as “Progressive Relapsing MS”, as their neurologists are definitely not waiting for the patient to fail any one of the ABCRs first (whose efficacies range from 29% to 34% respectively). See the following memorandum which issued by the FDA clarifying the above:

   “FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable totolerate, alternative multiple sclerosis therapies (e.g., as second-line therapy).

   However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.”

   http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf

   You also stated the following in your article, “There are over 10,000 MS patients worldwide who take Tysabri. PML has not been a problem with any other patient”.

   This is also incorrect in that there are over 27,000 MS patients worldwide currently on Tysabri therapy, and when used as a monotherapy, there have been zero cases of PML since its reintroduction in 2006.

   As many patients look to your website for accurate information, it would be appreciated if you would correct your article above.

   Please feel free to contact me should you require any further information regarding Tysabri as I was one of the MS patients that testified (via videotape) before the FDA AC in March 2006 in an effort to bring Tysabri back to the market.

   Respectfully submitted,

   Lauren Roberts

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