Not a comment but an important question, foremost to the research team
in relation to the article posted on
is VERY likely that I am one of those people with thrice as high Vit B
12 levels than normal (blood tests for over 3 years). Nobody can explain
why. From my own research I strongly suspect pernicious anemia because
I've got 2 disorders linked to that (I also have iron deficiency which
coincided with the onset of RRMS).
So my question is: which
tests should I suggest to my GP next time I see him in order to know
what's going on for sure? Since I've got more than one autoimmune
disorder it is imperative to tackle a faulty Vit B metabolism, methinks.
Your thoughts on this would be GREATLY appreciated - I've hit a brick wall so far with my doctors.
Re: "So my question is: which tests should I suggest to my GP next time I
see him in order to know what's going on for sure? Since I've got more
than one autoimmune disorder it is imperative to tackle a faulty Vit B
I suggest you make your GP aware of the
article in the NEJM and he/she should screen you for auto-antibodies
associated with pernicious anaemia and/or do a Schilling's test. The
latter is a specialised test done by haematologists to assess the
absorption of vB12.
Please note this blog is not the forum for personal medical advice. So I can't give you anything more specific.
You personally can not have half a relapse (0.5) so in this case it would be one relapse every two years as you say
terms of the 50% reduction in relapse rate, this means that you have
half as many relapses as would occur if you were not having the drug.
if the Annual relapse rate on drug was 0.25 compared to 0.5 on placebo.
It means that on average people on placebo have one relapse every two
years and the person on the drug had on average on relapse every 4
years. As you say this is an average so the middle mark and within any
trial some people to better than the average and some people to worse.
so what does 70% reduction on Tysabry mean? NO RELAPSE for some and full
relapse for the rest, or reduction for all on an equal basis?
no relapse of full relapse there is nothing in between in this context.
You have a relpse or you do not. There is nothing about a mild or
severe relapse in this context
If you have a 70% reduction of
relapse it means you are 70 percent less likely to have a relapse that
would occur if you took nothing=placebo
So if 100 people were taking tysabri only 30 would relapse compared to a 100 taking placebo.
The beneficial effect is statisitical and not impirical and not on an equal basis
if you relapsed does this means the drugs failed... well not
necessarily as you may have been destined to have two or more relapese
as the drug got rid of one or two etc. of them. Likewise it could be
less severe than it would have been
Biogen-Idec return to me after 48 hours with this answer:
"We investigated this situation for you and can tell you that Tysabri has cut ARR by 68%".
Then I called to understand more and was outraged by their reply:
"We can not and will not disclose any more information"
calmly explained to them that this information is needed in my decision
making as it is a matter of life or death - and asked them to provide
me the info within the next 10 days or I will file a claim in the UK
You can read the actual figures in phase III trial the paper by Polman et al. As you will read it was based on a two year study.
one year of treatment, natalizumab reduced the annualized rate of
relapse to 0.26 relapse per year, as compared with 0.81 relapse per year
in the placebo group (P<0.001) (Table 2). The 68 percent relative
reduction in the annualized rate of relapse produced by natalizumab was
maintained at two years (P<0.001)".
"The proportion of
relapse-free patients was significantly higher in the natalizumab group
than in the placebo group at one year (77 percent vs. 56 percent,
P<0.001) and at two years (67 percent vs. 41 percent, P<0.001)".
If you are considering Tysabri please read the posts on PML.
Caroline Wilding (head of the medical information distribution dept) reached out and agreed to share the post marketing data.
I am potentially looking at 6 years of history for up to 80,000 users.
That should allow us to cluster in subgroups to understand more how Tysabri affects different patient-types.
One hick: I am not a medical professional and not allowed to received the data directly.
Can you kindly reach out to Caroline requesting the tape? She agreed to provide it : email@example.com
I will happily run the stats in Matlab once I get the tape.
I suspect that I am not considered a medical professional either.
Write to Prof G
with details of the conversation that you have had with Caroline
including what she said she would supply and the details of what you
have requested and a contact email.
I don't understand what you
mean by tape and in terms of looking at subtypes. Tysabri is licenced
for treatement of RRMS there is a study in progressive MS ongoing.