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.

that is an interesting ditty indeed. it would seem that some docs are looking at immunosuppression as another way to go after ms like they do with cancer.

in fact i believe i read somewhere (but forgot to bookmark it for reference...sorry) that one neuro is putting his/her patients thru a treatment regimen as someone who has been dxed with cancer. (i realize there are different ones...i am not well read enough on cancer tx's to know what all they are)

i often wonder how much mileage the drug companies are trying to get out of existing drugs as developing new ones (especially the monoclonals) will be so expensive.

i also find it interesting that a lot what appears to be cutting edge research and info on ms seems to be coming out of italy.

harry....i wonder if the low numbers are because those that dropped out were not on tysab as a monotherapy?

in other words, were they also on one of the crabs and when problems started showing up they left the study?

i agree there is an awful lot of hype around this drug, and for some it may work well, but we all know that no single drug is going to work for ALL of us.

i still think this is a good drug for some....i am glad it came back to market. the monoclonal market is exploding and we are going to see a lot of new ones in the next 5 years or so i bet.

the way i look at it is even if the relapse rate is no better than the crabs, at least the folks on tysab don't seem to be sick as dogs like most those on the interferons.

like sally said, quality of life counts for a lot.

Actually, the relapse rates are considerably better then the CRABs; it is "disease progression" rates that don't appear to be much better.

One advantage of the CRABs, at least at this point in time, is that they have a fairly good safety record/history. Tysabri has had some hiccups in this regard, but hopefully will prove safe and effective in the long run.

Cherie

hmmm...i missed that important distinction....thanks lady.

.... guess i am of the mind that something is better than nothing at this point.

i am unable to take the interferons, had an adverse reaction to copax, and can't go on tysab as i was in a double blind study for rituxan.

(i opted for that study as it has been on the market since 1996 i believe and seems to be showing some promise in studies for auto-immune like ra and lupus)

actually i was signed up to be one of the first to go on tysab in my area this last july.(it was yanked 2 weeks before my first infusion the first time around) but backed out due to a strong gut feeling at the last minute.

i know now (even tho i was not unblinded) i got the real thing as my b cell count is not normal after a year (a plenty long enough wash out time) which means i am suppressed so tysab is off the list for me.

good thing.....i found out about my abnormal b-cell count after what would have been my second infusion.

so i'm kinda hanging around waiting to see what other drugs come up in the pipeline.

there seem to be some interesting studies going on in canada right now and i know centerwatch has one listed for clabridine in the u.s. right now. i believe it is called the clarity study.

i am just a bit frustrated right now i suppose.....lol...we have all been there tho i guess.