Tcz: I have been reading on other websites about... - PMRGCAuk

PMRGCAuk

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Tcz

Nap1 profile image
Nap1
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I have been reading on other websites about TCZ. Apparently it is being used now for the treatment of GCA in Europe and the US. Last I heard on this website was that the results would not be available until 2017. If anyone has the facts would you be so kind as to post it. Thank you

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It is part of an on-going international clinical trial, GiACTA, which has centres in the UK, Europe and the US. Until now (or at least relatively recently) though no patients/doctors would have known whether they were on TCZ or the placebo as it is a double blinded study.

clinicaltrials.gov/ct2/show...

It was the subject of this Roche/Uni Bern study:

thelancet.com/journals/lanc...

To the best of my knowledge, it isn't available in general for GCA because it has not yet been submitted for licensing in GCA, an essential step in the use of any drug. If rheumatologists are using it then they are using it off-label and I believe there are patients in the US whose doctors are listing their diagnosis for other forms of arthritis as "sero-negative arthritis" which slightly fudges the issue but legally is adequate for insurance purposes. They can't do that for GCA patients.

I have come across people on the forums with GCA who have been put onto it in the US - however, I have no idea how they are funded. One lady posted to ask how she could find funding - she had been to (I think) the Mayo and a rheumatologist had told her she should be put onto TCZ. However - she would have to fund it herself at $17k per year.

It is not yet licensed anywhere as far as I know for use in GCA - it is licensed for various forms of RA under certain conditions:

ema.europa.eu/docs/en_GB/do...

and

ema.europa.eu/ema/index.jsp...

and this is the current status of the licence extension to GCA

ukmi.nhs.uk/applications/nd...

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