This Is MS Multiple Sclerosis Community: Knowledge & Support

Since I posted the data plots for Avonex I thought that it would be interesting to look at the data given in the Dr's Prescribing Information for Tysabri (and it would only be fair especially considering that this is a Tysabri forum). I was suprised to see how similar the following data plot for Tysabri is compared to the one for Avonex. I'm still not that impressed. Not to put Tysabri down but hopefully some of the upcoming treatments, such as Tovaxin, will do much better.



NHE

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I'm not sure what to tell you but one consideration to always ask is who funds their research? Even if a researcher is not obviously biased it can sometimes be difficult for them to not wear rose colored glasses. Of course, your doctor could just be sharing other's experience with Tysabri with you. This disease is so variable from one person to the next that, as HarryZ noted, it may very well be the case that some people were able to give up their walking cane. Since the other patients were still ambulatory, Tysabri may have not been the only factor in their recovery. It could be the case that they were doing physical therapy or using other complementary treatments.

NHE

Hello

This is my first post to this forum board. I wanted to let folks know that I will be taking my 14 dose on November 1, 2007. I can't explain the excitement that I actually have with being on Tysabri. I am a 37 old female that has been diagnosed for 8 years. I have a 6 years old son and have been married for 7 years. About 5 years ago that my gait really really slowed and my balance was a complete mess. I was barely able to handle normal everyday life.

The first couple of months were very tuff on Tysabri. I experience shingles every month for the first 5 months. Then after that my strength started to return the shingles did disappear. I did have two set backs due to a infusion nurse deciding that she didn't need to give the dose every 4 weeks. That was the worst two experiences that I have had on Tysabri.

I did find a fabulous new Neurologist and I will never change again. He has me on the correct dosage and every part of the TOUCH program is followed. The shingles have not come back and I have gained the ability to walk with a walker without my right foot AFO.

I can also balance myself for 5 minuets without holding on to anything. My strength has come back the fatigue has simply vanished. I have gained fealing in the lower part of my legs, that's important because it's been 7 years for that to happen.

The gains have out weighed the small percentage of PML. I guess if the percentage was even higher I would still take this medication. I tried all the other drugs and nothing simply nothing did what the Tysabri has brought back to my me and my family. I keep my fingers crossed that maybe by the next baseball season I will be able to teach my son how to play baseball.

Sincerely
Heather

Underdog, thanks for sharing your experience. I've been on Tysabri for 3 months and I feel that I have better heat tolerance, and my vision problems are virtually non-existent. My gait and balance have improved, just slightly. I hope to see further improvements.

Speaking to the original post, obviously there are caveats to consider with any study results released, and then of course, you have to consider that with people who have RRMS they might have gotten better anyway, whether on or off a drug. For me, I have to consider my personal experiences. On Avonex, I was feeling progressively worse. Now, on just a few months of Tysabri, I am already feeling better. Would this have happened anyway? Perhaps. But I prefer to stay on the Tysabri until something better comes along.

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Saw your post up above where you said your neuro thought that Rebif was the best of the ABCRs and that Tysabri showed only slightly better efficacy in trials, and want to respond:

1. Rebif and Avonex are exactly the same drug - the same protein from start to finish. The only significant difference between the 2 is the way they are dosed: subcutaneously versus intramuscularly (small, frequently administered needles or one big honking needle once per week.)

2. Tysabri showed hugely better efficacy than Rebif or any other ABCR in trials. After 2 full years of Tysabri treatment, the drug group had 10% of the number of lesions that Avonex trial users had in just 6 months.

And, where ABCR meds at best (including Rebif) have a questionable 35% reduction in relapses, Tysabri showed a very rigorous 68% reduction in relapses. By contrast, placebo-treated groups often show a 20% reduction in relapses!

The SAEs with interferons are significant, too. At worst, Tysabri is no less safe than the interferons in terms of mortality (and I think that it is far better due to better effect on MS itself as well as positive RA and circulatory effects.)

You are of course already benefitting from Tysabri but I just wanted to respond to your post in case anyone reading it were to think that Tysabri is just a slightly better Rebif.

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You can bet that the makers of Avonex, Rebif and Betaseron don't have this serious adverse effect profile listed in any of their literature. I guess that doesn't make for good potential sales to MS patients and their docs.

Having said that, one of the partners of Tysabri is Biogen/IDEC. They certainly don't mention this list to anyone. They are obviously aware of the potential problems yet they combined Avonex with Tysabri in clinical trials before Tysabri was approved the first time by the FDA.

What does that say about a company's interest in the health of MS patients? And Tysabri had double the infection rates of placebo patients during the trials. It's going to be some time before we really know and understand the safety level of Tysabri. And one more question....do we really trust Biogen/IDEC to tell us any problem information about this drug? Let's hope they are more forthcoming about Tysabri than they have been with Avonex!!

Harry

Interferon Beta is not exclusive to Avonex. Betaseron and Rebif are also interferon beta immune modulating medications, so Avonex can not be singled out.



This statement is incorrect. Note that a total of 1617 multiple sclerosis patients in controlled studies received Tysabri. In Studies 1 (monotherapy) and 2 (combo therapy), the rate of any type of infection was approximately 1.5 per patient-year in both TYSABRI®-treated patients and placebo-treated patients. The infections were predominately upper respiratory tract infections, influenza, and urinary tract infections. Therefore, the infection rates were approximately the same in both Tysabri treated patients and patients that received the placebo, not double.

In Study 1, the incidence of serious infection was approximately 3% in TYSABRI®-treated patients and placebo-treated patients. Most patients did not interrupt treatment with TYSABRI® during infections.

The only opportunistic infection in the multiple sclerosis clinical trials was a case of cryptosporidial gastroenteritis with a prolonged course.

In clinical studies for indications other than multiple sclerosis, opportunistic infections (e.g., pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, and burkholderia cepacia) have been uncommonly observed in TYSABRI®-treated patients; some of these patients were receiving concurrent immunosuppressants (see WARNINGS, Immunosuppression). Two serious non-bacterial meningitides occurred in TYSABRI®-treated patients compared to none in placebo-treated patients.

In post-marketing experience, one patient who received TYSABRI® developed herpes encephalitis and died; a second patient developed herpes meningitis and recovered with appropriate treatment.

Lauren

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My intention was not to signal out Avonex but to indicate that Biogen produced both Avonex and Tysabri.



I did two quick searches for Tysabri safety data and here is what I found:

"The adverse event profile in SENTINEL and AFFIRM were similar at one year. Common adverse events included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, joint pain and abdominal discomfort. The rate of infection was approximately one per patient-year in both TYSABRI-treated patients and placebo-treated patients. Serious infections occurred in 1.3 percent of placebo treated patients and 2.1 percent of TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions, which occurred at an incidence of less than 1 percent of patients."

"According to the companies, the safety profile of Tysabri over two years was consistent with findings announced for the first year. Common side effects included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, limb and joint pain and sore throat. The overall incidence of infection was similar between those on Tysabri and those on placebo. Serious infections, such as pneumonia and urinary tract infection, occurred in 3.2 percent of participants on therapy and in 2.6 percent on inactive placebo. Tysabri has been associated with hypersensitivity reactions, including serious systemic reactions that occurred at an incidence of less than 1 percent of patients in the trial. Longer term safety information is not available."

Now I'm not sure what some people feel the word "consistent" means but going from 2.1 to 3.2 per cent in users and 1.3 to 2.6 in placebo is not what I would say is consistent.

The original data from the Tysari trials showed, if I remember correctly, that the infection rate was just above 3% for users and about 1.5% for placebo. This is what Biogen told us and have massaged these numbers since but they don't exactly have the greatest reputation of trust in the world of medicine. Like I said earlier, it will be some time before we really know the true data for Tysabri from its use outside the clinical trial setting. And whatever its efficacy numbers turn out to be, it won't take much to be better than the interferons!

Harry

I provided the original data from the Tysabri trials in my post. I therefore stand by my post that your previous comments were and still are incorrect.

Personal opinions and positions will vary, but data won't.

Lauren

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Feel free to visit my Blog and leave me a comment, I'd love to hear from you!

http://lauren-livingwithms-aolcomlglbgl ... gspot.com/

Co-owner of a MS Support Group

Well, the first article I quoted was taken from an NMSS publication and the second came from a news article quoting Biogen as the source. What I stated and still stand by is that Biogen has massaged these numbers in later info releases. They are known for this and is one reason why experts in the field don't trust everything they say. This info isn't my personal opinion but what people like the NMSS and neuros state.

Biogen would like everyone to believe everything they say but people who have been around them for some time know that their marketing people are second to none in the pharma world and are very good at what they do. You just have to be able to sift through their rhetoric.

Harry