PML 3 more cases

[ewizabeth]

I get my 32nd infusion tomorrow. I'm going to ask my neuro his opinion on the risks and if he thinks they're greater than 1:1000 now.

I'm also going to talk to him about taking a break. I'm 99% sure that's what I want unless he can give me a good enough reason why he thinks that's a bad idea.

Like you, part of my decision for taking a break is because they're withholding information. What else are they keeping from us?

I think it's going to really rise now that there are so many people who've been on it for over two years. That sounds awful, but the way that guy at Vanderbilt had expressed the odds and how they decrease so drastically after 18 mos. and 2 years and so on really gives me pause because a huge chunk of the tysabri taking population is probably approaching those doses.

[yonderboy]

I'm probably out too. Just trying to come up with a way to determine if there's any JC virus activity in my blood.

So the question I've been asking myself is where do I go from here? Anybody else thinking about Campath? My neuro says that there is no safety information on any patients who've moved from Tysabri to Campath. For the latest U.S. Campath trials, one of the exclusions for potential participants was "...taking Natalazumab in the last 6 months.." - So somebody out there thinks its safe to take Campath 7 months after Tysabri... Any thoughts from my esteemed Tysabri breathren would be appreciated!

ps. And yes I understand that you can only officially get Campath for MS as a trial participant. I also understand (through following the Campath thread on this site) that there are people currently receiving Campath off-label in the States.

J

[prof8]

Latest info on PML cases.

8 cases out of the 24 are in the US. 4 deaths out of the 24.

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[ewizabeth]

An excerpt from the linked article that Prof8 just posted:

[Updated comment from Biogen Idec.] There isn’t any data that suggests imposing a drug holiday would reduce the risk of patients getting PML, but there is data that shows symptoms of multiple sclerosis return quickly once patients quit taking natalizumab, says Biogen Idec spokeswoman Naomi Aoki. The company is talking with regulators about the best way to update the drug’s prescribing information to reflect the increased risk with extended usage, but even so, the incidence of PML still appears within the stated range of 1 in 1,000 patients, she says.

Ok, so I was told on Monday that the symptoms (or disease activity) return about six months later.

But this article says ... there is data that shows symptoms of [MS] return quickly ... [after going off Tysabri].

I'll ask the neuro about this tomorrow. I better make a list of questions or I'll forget to ask something.

[prof8]

See those are the kind of statements that make me not trust Biogen. My doctor told me disease activity comes back in 6 months. It sounds to me like the spokesperson Naomi is spinning a dire prospect-- you shouldn't go off Tysabri or your disease will come roaring back. Money is what they want. let's scare the patients into staying on the drug. This really ticks me off. It's the little things like this that are going to make me decide to go off the drug.

[RuSmolikova]

...Money is what they want. Let's scare the patients into staying on the drug...

You are absolutely right. Just read their older phone calls with investos... They are talking about the strategy how to persuade MD´s to be more comfortable with the drug connected with so serious side effect...
And admit that drug holidays would lower their revenues...
The patient is the last point in the queue of their interest.
Shit!

[dreddk]

Interesting study on risk benefit of tysabri perhaps becoming more relevant now...I guess its really going to come to individual assesment of the risk one is willing to take (based of course on the supplier being honest about the true risk...)

"Our results show that the benefit of long-term treatment with natalizumab far outweighed the risk of developing PML. A more than sevenfold increase in the risk of PML was required (from 1 to 7.6 patients per 1,000 treated over 17.9 months) to reduce natalizumab’s health gain below that of IFNβ-1a’s. This increase in risk is outside the 95% CI of the current PML risk estimate (0.2–2.8 per 1000 over 17.9 months of treatment).2 It may not be, however, outside the tolerance of many MS patients. Approximately 55% of MS patients indicated in a recent survey that they definitely or probably would use a “treatment for MS that was significantly more effective than currently available drugs,” even with a 1 in 1,000 chance of a fatal side effect.32 Approximately 18% of patients surveyed would tolerate a risk of 1 in 100, and 14% would tolerate a risk of 1 in 10. Thus, even if there were an increased risk over time due to cumulative exposure to natalizumab, it would likely be tolerated by some MS patients."

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676947/

[RuSmolikova]

See the date of the survey: August 23, 2007.
Let me mention that the new cases of PML have been released since July 2008. I guess that the participants didn´t know anything about the real risk, they considered the theory only...
But the risk is very real, now.
It would be very interesting to see how the participants of the survey have changed their minds...