The primary endpoint will compare the effect of TYSABRI to Rebif on the rate of clinical relapses. Secondary endpoints include analysis of the proportion of patients remaining relapse free, MRI brain scans, safety, tolerability and quality of life. To help ensure the objectivity of data emerging from STARS, relapses will be assessed and determined in a blinded fashion by an independent panel of experienced neurologists who are not participants in the study.
dancingfish wrote:What is odd is our neurologist is ready to use Rebif and Tysbri right now..
HarryZ wrote:Hmmm...the most powerful of the interferons that has the most side effects combined with a monoclonal antibody and there is no data on how this combination might work!! Don't think I would want to be the "guinea pig" in this situation.
Well, to be fair, they do have 1 year data on Avonex + Tysabri and it appears quite safe. It is unlikely Rebif will be much different.
They are using Avonex with Tysabri to show that interferons are safe and effective taken with Tysabri and using Rebif and Tysabri to show (presumably) that Tysabri is better than interferons. From a marketing perspective it will look much better if there is only data showing the benefits come with Avonex and the lesser effects come with Rebif - even though you could pretty much swap the two and expect the same results.
Sly marketing weenies strike again.
Rebif is a more potent interferon and is the one that is most capable of producing NAbs. According to the John Hopkins Tysabri webcast, 9% of the Tysabri users in the trial ended up having to stop the treatment due to high NABs that weren't going away after a number of months. Now combine the two...hmmm...don't think I would want to be taking them!
Actually, Betaseron has the highest incidence of NAbs (and the Tysabri product spec say 6% had NAbs to Tysabri), but I'm not sure what danger you are alluding to. NAbs *neutralize* the drug in question - making it ineffective. It's like not taking the drug. Nobody has reported a danger from this (other than financial).
With Tysabri they seem to know how to detect them and when they are likely to occur, so you can be taken off the drug and not waste your time/money using it if you are in the unlucky group.
As to the combination being worse, I'm having a hard time imagining how NAbs to one drug would have anything to do with the other given how utterly and completely different their structures are and how specific antibodies are.
Can you illucidate how your fears might manifest themselves? I can understand a general "this is a new compound, I wouldn't stick it in my body until more is known" (I'm sort of in that camp) but you seem to be hinting at something more specific.
I don't think we've seen any vendor specific drug interactions with the interferons so far. The NAbs differences seem to be due to route of administration and production quality, not dose level.
EDIT: I just checked - Tysabri NAbs appeared in 10% of subjects at least once with 6% having persistent NAbs.
NABs can do a lot of damage to you other than just make your MS medication useless. They can wreck havoc with your immune system if left untreated. Many patients on the CRABs experience elevated NABs but most patients have the NABs return to normal after a period of time. Some people, however, have to be treated if they don't go down on their own.
I've never heard of this. Got any pointers or other info on it? What sort ot treatment do they get? I'd like to know more.
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