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Crohn's Disease Forum » Treatment » Cimzia/Certolizumab » The use of cimzia and natalizumab in the EU


03-04-2011, 09:43 AM   #1
Misty-Eyed
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The use of cimzia and natalizumab in the EU

So while at work today, I came across this information that some people may find interesting as to why the use of these two drugs are not used in the EU for Crohn's.

Below are the direct links. Hope you're all well

http://www.ema.europa.eu/ema/index.j...01ac058001d125

http://www.ema.europa.eu/ema/index.j...01ac058001d125
03-04-2011, 11:19 AM   #2
littlemissh
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Interesting. Don't think I would like either then!
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03-04-2011, 11:31 AM   #3
ThanksP
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It's interesting that they really don't cite much of a reason for not allowing the use of Cimzia. It's too bad because I'd like to think that if it works for someone who has tried everything else, then it's worth it.

Now the Tysbari....ehhh, I don't know that I'd try it either.
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03-04-2011, 12:15 PM   #4
Misty-Eyed
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Well I'm guessing it would be based on the clinical trials. If it's not shown to be effective in enough patients, the risks of giving the drug don't outweigh the advantages. If that makes sense.

It's interesting that the FDA have approved Cimzia though whereas the EMA haven't..
03-04-2011, 03:06 PM   #5
bwightman
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Just a question....Cimzia is approved in the EU to treat RA, right? The reason I ask is that my doctor (who's originally from Ireland) stated that in Europe they combine Cimzia with Imuran quite a bit. I assumed he was talking Crohn's, but maybe he meant in general, or for RA patients, or for patients in studies...

Either way, that's the course of treatment he put me on, and even though it's only been about a week, I've noticed I'm feeling a bit better...or more importantly, not feeling any worse.
03-04-2011, 03:08 PM   #6
soupdragon69
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Very interesting reading indeed. Time will tell what happens in the long run. I agree though - wouldnt want the Tysbari at all and wouldnt be comfortable with the potential bleeding with the Cimzia either.

I have just had my remicade/infliximab stopped since new year - would have been on it 4yrs this May - and have always been a bit twitched about the murine aspect of it. Its been stopped because I caught the flu despite my vaccination and ended up admitted with respiratory problems for 9 day in January. Gastro think that the remi has immunosuppressed me too much and its why I am only really recovering now in any meaningful way. Am waiting for review in clinic to decide the next step as I now have nothing meds wise on the crohns front. Watch this space ;-)
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03-04-2011, 03:28 PM   #7
Misty-Eyed
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bwightman- yes, it's approved for use in RA, but not for Crohn's. Interesting that he said that then!

soupdragon- I hope you are feeling better now! A shame that happened if it was working well for you still. Did you try Humira already?
03-04-2011, 07:59 PM   #8
ThanksP
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Very interesting reading indeed. Time will tell what happens in the long run. I agree though - wouldnt want the Tysbari at all and wouldnt be comfortable with the potential bleeding with the Cimzia either.
According to the link, the concern over bleeding was removed in March of 2008.
03-05-2011, 04:31 AM   #9
soupdragon69
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Hi Misty, Yeah it was working fairly well for me as was on it every 6wks. Havent had Humira but it has been discussed in the past as a back up if the Inflix didnt keep things at bay. We will see eh?

Hi ThanksP, Yes I am aware it was "removed" but a drug like that will always have it as a potential side effect even if the "major risk" was removed, just as many others do.
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