Why are so few on Cimzia?

[nogutsnoglory]

It seems that very few are on or have tried cimzia? I'm going to start and I'm concerned that I'm going on a less well known drug. It seems most jump to humira or remicade.

I know remicade is the oldest and has the most research but cimzia and humira both were approved in 2008.

 

[Dukeis]

It seems that very few are on or have tried cimzia? I'm going to start and I'm concerned that I'm going on a less well known drug. It seems most jump to humira or remicade.

I know remicade is the oldest and has the most research but cimzia and humira both were approved in 2008.

I think it is because it is the newest med and it is when the other 2 have failed or stopped working that people go to cimzia. I know my GI told me when I restarted Humira if it never worked we would go to cimzia.

 

[nogutsnoglory]

But Cimzia and Humira both released in 2008.

 

[Dukeis]

Well I guess I'm thinking of when I was told about them. My doctor at Mayo talked about Humira years before Cimzia. I guess that is why I thought Humira came out first.

 

[ThanksP]

I started on Cimzia first. Then went to Remicade. Never tried Humira.

I wonder if the difference is because Cimzia is not FDA approved for UC, only Crohn's (at last look, maybe it is now). And I think Humira was approved for RA back in 2002, so doctors might have begun using it later for an off label use before it was fully cleared by the FDA for Crohn's and subsequently UC.

 

[nogutsnoglory]

I started on Cimzia first. Then went to Remicade. Never tried Humira.

I wonder if the difference is because Cimzia is not FDA approved for UC, only Crohn's (at last look, maybe it is now). And I think Humira was approved for RA back in 2002, so doctors might have begun using it later for an off label use before it was fully cleared by the FDA for Crohn's and subsequently UC.

That makes sense. I know cimzia is only for CD and RA. It's probably the other meds were used off label.

 

[xSophiexx]

ThanksP in the UK Remicade is for Crohns treatment you can get it no problemo but for people with UC it has to be signed off by the powers that be.

I personally have never even heard of Cimzia and they're trying me on everything they can due to my intolerance of thiuprines. perhaps Cimzia is more prevelant in the US ...

Out of interest is it another biologically or an immunosupressant?

 

[ThanksP]

Cimzia is another biologic (like Humira and Remicade). I don't believe it's been approved in the UK. And I think it's still in trials in Canada.

 

[xSophiexx]

ThanksP .. well that would be why i haven't heard of it then lol i thought my doc was playing hard to get with secret treatments for a minute there!

 

[Misty-Eyed]

Cimzia was rejected for use in Crohn's in the whole of Europe.

The reasons are below;

'In November 2007, the CHMP was concerned that there was insufficient evidence to show a benefit of CIMZIA. In the study of induction treatment, CIMZIA showed only marginal effectiveness, which was too low to be relevant for patients. In addition, the study of maintenance treatment did not last long enough to give meaningful information on the medicine’s long-term effects.

The Committee was also concerned over CIMZIA’s safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving CIMZIA. In addition, the Committee was concerned that the company had not demonstrated that it would have been able to monitor the quality of the medicine to an acceptable level.

In March 2008, following the re-examination, the CHMP removed its concern regarding the ability to monitor the medicine’s quality. It also removed its concern over the possible increased risk of bleeding, but maintained a general concern over CIMZIA’s safety. The other concerns remained. Therefore, at that point in time, the CHMP was of the opinion that the benefits of CIMZIA in the treatment of severe, active Crohn’s disease did not outweigh its risks. Hence, the CHMP recommended that CIMZIA be refused marketing authorisation.'

 

[nogutsnoglory]

I wonder why it's good enough for the FDA but not Europe. It's also marketed for moderate to severe crohns and not mild crohns so they must see some efficacy.

 

[ThanksP]

I wondered that as well because it carries the same safety warnings as Remicade and Humira.

But anecdotally, I have noticed that it hasn't seemed to work long term for many on this board (including myself).

 

[nogutsnoglory]

It's preferable to the infusion so id like to give it a shot. Haha literally.

 

[Dukeis]

I wonder why it's good enough for the FDA but not Europe. It's also marketed for moderate to severe crohns and not mild crohns so they must see some efficacy.

That's easy! Pharmaceutical Company Money!

 

[ThanksP]

It's preferable to the infusion so id like to give it a shot. Haha literally.

I think I've said this before. But honestly, I prefer the Remicade infusion to the hassle of the Cimzia deliveries, orders, delays, weather conditions, traveling, etc. But I chose Cimzia over Humira because a once monthly shot is better than twice a month. And I've read that Cimzia is a LOT less painful than Humira.

 

[Misty-Eyed]

I wonder why it's good enough for the FDA but not Europe. It's also marketed for moderate to severe crohns and not mild crohns so they must see some efficacy.

The FDA has a reputation of being more lenient than the EMA (European Medicines Agency) when it comes to approving drugs so maybe that's why?

Also drugs are measured by risk/benefit ratios. So in mild Crohn's, the benefits of taking the drug would not outweigh the risks of taking the drug. If that makes sense!

 

[nogutsnoglory]

The FDA has a reputation of being more lenient than the EMA (European Medicines Agency) when it comes to approving drugs so maybe that's why?

Also drugs are measured by risk/benefit ratios. So in mild Crohn's, the benefits of taking the drug would not outweigh the risks of taking the drug. If that makes sense!

But it's approved for moderate to severe.

 

[Misty-Eyed]

Yes because to help symtoms of moderate to severe crohn's, you can take more risks with the side effects.

As an example, if you have Drug A. Drug A if found to improve headaches and can also cause remission of cancer. One of the common side effects of Drug A is high blood pressure.

Risking having a patient having high blood pressure by taking the drug to improve a headache isn't worth it, as the side effect is worse than the symptom you are trying to improve. But it would be worth risking high blood pressure to get remission from cancer. So the drug would be approved for cancer but not for headaches.

I know that's a bit of a rubbish example, but I hope that makes it clearer? Basically having mild crohn's isn't worth risking the side effects of cimzia.

Either that or it's just not been proved to be effective enough in mild crohn's.

 

[xSophiexx]

Misty-eyed it was a good example made sense to me!!

 

[nogutsnoglory]

I get the example as a reason not to allow it for mild crohns but not severe in Europe.

 

[Misty-Eyed]

The EMA basically don't believe that the effectiveness of the drug is good enough to warrant the risks of the side effects for even severe Crohn's.

 

[nogutsnoglory]

It's so strange how they can differ so much. Anyways, I hope it works.

I wonder if they use it off-label for crohns in Europe.

 

[Misty-Eyed]

Yes I know! I very much doubt they use it off-label in the UK because consultants actually have to apply for the funding from the NHS for patients in the UK to receive Humira or Remicade. They wouldn't allow the public funding for something off-label. I'm not sure about other countries in the EU though!

I hope it works for you too! Update me! I'd be interested to hear how it's going and if you get any side effects!

 

[nogutsnoglory]

I definitely will update and pray it works.

 

[kh216]

In addition, I think it has a lot to do with advertising and doctor preference. My GI doctor is a Remicade man, and if I needed to go on a biologic, he would want me to try Remicade first. Abbott is a powerful pharmaceutical company and I am constantly seeing their advertisement for Humira on television.

 

[nogutsnoglory]

That's true I see humira commercials all the time. I have never seen a remicade one. I think I may have seen a cimzia one for arthritis.

UCB which produces Cimzia also produces crohns advocate magazine.