New Data Presented At ECTRIMS Congress Show TYSABRI® Has Sustained Effect On Relapse Rate In Multiple Sclerosis Patients Treated For Up To Three Years

Biogen Idec
9/29/2006 11:55:08 AM

Patients who participated in the Phase III TYSABRI program were eligible to enroll in an open-label extension study that evaluated the therapy’s long-term effects. Approximately 1,900 patients and over 200 sites worldwide participated in the extension study. Approximately 250 of these patients remained on TYSABRI monotherapy for nearly three years. The annualized relapse rate for these patients over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. This was consistent with the 0.23 annualized relapse rate seen in the two-year AFFIRM study, which represented a 68% relative reduction when compared to the two-year placebo annualized relapse rate of 0.73, as published in the New England Journal of Medicine.


"Data from this long-term follow-up study show that TYSABRI has a sustained and compelling effect on relapse rates beyond two years of treatment. The efficacy benefit of TYSABRI when considered with the management of its known risks, offers an important therapeutic option for many patients living with the debilitating effects of MS," Paul O’Connor, MD, St. Michael’s Hospital, Toronto, Ontario, Canada, lead investigator of the extension study.

http://webwire.com/ViewPressRel.asp?...NID=&aId=21325

Hmmm...Only 13% (250)of the original 1900 patients remained for the open label extension study. What happened to the other 87%? If you only take the data from these 250 patients, who obviously were doing well on Tysabri, it's not surprising to arrive at those efficacy numbers! Or am I missing something here?

Harry

Hi Harry,

I really like to get to the "bottom line" about what these drugs actually do or not do, taking away all the hype and spins put on them.

So comments like yours are very much appreciated because I hadn't noticed that part, that so few of the initial participants were examined on long-term follow up.

Thanks for bringing that up!

Thanks Wannabe. I think that a bunch of us PWMS are coming to a consensus about all of the Modulating Drugs, and all the hype that surrounds them.

I know that I have never regretted stopping jabbing myself with those poisons. I mean I was of the same mind as the rest of you, at one time. I was willing to put up with the sucking of my quality of life, just for a chance that they may be helping me, in the longrun. NO MORE!!

Good point, Harry.

What bothers me about the hype around "reduced relapses rates" is that this is ONLY a secondary measure of these trials.

The PRIMARY measure is "reduced disease progression" (not sure if this is the exact wording they use, but ...) those stats aren't any better then the Avonex ones (according to xo's previous post).

Then you read an article like the following, and you have to wonder if stopping relapses is even the best course of action :

Curr Med Chem. 2006;13(19):2329-43.

Current status and future prospective of immunointervention in multiple sclerosis

Cavaletti G.
Dipartimento di Neuroscienze e Tecnologie Biomediche, Universita di Milano Bicocca, Via Cadore 48 - 20052 Monza (MI), Italy. guido.cavaletti@unimib.it.

Multiple sclerosis (MS) is a complex neurological disorder characterized by inflammation and degeneration of the central nervous system, primarily involving the white matter.

On the basis of a wide body of evidence in experimental models and in affected patients, several attempts to treat MS using drugs which modulate immune reactions have been performed or are currently ongoing.

However, it should be stressed that inflammation does not have only a detrimental effect in MS. In fact, parts of the inflammatory events are crucial for the control and conclusion of the acute phase of damage and it is probable that they actually favor regeneration and recovery.

Due to the above, several trials with immunosuppressant drugs failed or were suspended because of unexpected worsening of the course of MS.

The knowledge of MS immunopathogenesis is so rapidly evolving that any attempt to review it is in some way frustrating. On the other hand, this evolution is at the basis of the several new treatment options which can be hypothesized for this disease.

The current status of immunosuppression in MS and the possible future development of MS treatment will be reviewed, with particular reference to those treatments which have already been tested in clinical trials and which are based on sound evidence of a putative interference with specific events occurring in MS, with the sparing of general immunity.

http://www.ncbi.nlm.nih.gov/entrez/q...&dopt=Abstract

http://www.ingentaconnect.com/conten...rdihiqr1.alice

Cherie

Makes sense, Cherie. Inflamation is not all bad....and neither is Fever. They both have some curative mechanisms.