Cimzia: Jeff's Diary

As asked I will document to the best of my ability my Cimzia journey. A little background. I am not currently in a flare but the amount of scar tissue in my rectum keeps causing it to close up. I will probably need surgery sometime in the near future to get rid of the five inches or so of scar tissue but hopefully the Cimzia works to keep the scar tissue from growing again or at least that is the hope.

Background on Cimzia:
It is a drug like Infliximab and Humira in that it uses a protein to target the inflammation. They use two injections, one in each leg(although they said I could get it in my stomach but they like the leg best), and they inject into the fat layer right under the skin. The needle barely hurts. The drug itself is a rather thick liquid being more like a syrup then a liquid and this results in a rather slow injection rate being around 10 seconds a needle. The Cimzia has a slight burn to it as you feel it heat up your leg gradually as the drug makes its way around your leg and into your body. It is a relatively quick treatment but it takes 20 to 40 minutes for them to mix it up so you have to call ahead to get the treatment and it is rather expensive, being around $5000 US a treatment. I think I have more to add but I'm sleepy so I'll write more later. If I forget then could someone let me know. Thanks

I started my Cimzia on 1/8/09. So far I haven't seen much improvement since I had the dilation that day as well I can't tell how well it is working. My stool is solid but soft which it lacked before and it is much larger than it was before the dilation. I get periods of time where I get my color back and other times where I lack color.

It seems to take a few injections to start taking full effect. I go back on the 22nd for my next two shots.

Jeff,

A few questions:

After the initial injections, do you go down to one injection per treatment? Will you eventually be able to mix and inject it yourself? After the initial injections, do you take it once or twice a month?

I'm on Humira and it is working well, but my insurance doesn't cover it. I'm trying to figure out if my insurance will cover other biologics.

Thanks,
Greg

After the firt three injections, which are taken every two weeks, I will be going to a once a month injection. It should be the same for everyone else.

They think that eventually it will be similar to Humira but right now they are unable to get the mix to a consistency that an untrained person could handle. They are working on this problem and hopefully within the next few years they will have the right consistency.

My rectum seems to have narrowed quite a bit almost like I never had the dilation. I don't feel the dilation did much and so I will probably need to have surgery soon to get rid of all the scar tissue. I'm worried that everytime they try and dilate me they will make the scar tissue come back worse and worse. Other than the scar tissue I feel better and my color has come back some more. I don't have any inflammation or and signs of Crohn's at the moment so I'm not in a flare, I just have this damned scar tissue that loves to makes things my living hell.

what you said about the dilations actually increasing the amount of scar tissue is true i believe.
a surgeon i consulted with at massgeneral said that every time i dilate myself, tiny injuries are inflicted whichs heals over with a tiny amount of scarring. but over time it can add up to a bit. just her opinion or proven fact im not sure
i forget, is your stricture too far up that you cant dilate yourself? thats a bummer that you have to go to the OR everytime it feels narrowed.

I thought that my stricture was lower but appparently it is about six inches up my rectum. It's just a little too far for me to try and dilate myself, plus it feels a little too weird for me. I think I'm going to ask about stent, which is a flexible metal tube they can place in the intestines which keeps it from stricturing. Hopefully that would help me so I don't need surgery which I feel is coming closer and closer. I really don't want surgery but the way thing are going who knows.

On to Cimzia:
I have no pain except for my stricture which is in need of something to keep it from closing up. I go in for my second treatment on Thursday.

Unfortunately, as far as the FDA is concerned, they will never be allowed to change how cimzia is provided to the patient. With biologics there is no way to guarantee the same product everytime unless you follow the same procedure from start to injection everytime. It is one of the downsides of the medication due to limits of technology currently. Proteins are not like small molecules that can have their structures determined easily 100% of the time so the FDA simply follows the belief that if the process changes, you are generating a new drug which has to go through all stages of clinical trials again. Simply put, no company is going to spend the millions of dollars necessary in order go through clinical trials again when they already have a drug on the market.

I'm glad you are writing this journal as I am currently finding my Humira to be less than sufficient and the pegylation added to Cimzia makes it large enough to not be cleared by the kidneys, which is why you can get a smaller dose of it less often. It is basically the same as Humira in all other regards and has the same mechanism of action as Remicade, it is just a humanized MAb rather than chimeric(like remicade) which is a good thing.

Hopefully you'll get good results from the treatment and I wish you good luck with it .

Hope you are able to see some results from the Cimzia Jeff. Sorry to hear it's not working so well at this point with the scar tissue. Though I'm sure they told you it could take a couple of months to see results. Hope you can avoid surgery, but either way, keep fighting the good fight.

It could take a few months to see the results from the dilation. I thought it was supposed to be an immediate kind of thing. Could you possibly clarify that for me. I'm going to the GI's tomorrow for my next shots so I'll ask them. Thanks

I'm also, going to ask about if the thinning of the formula will cause Cimzia to go through the FDA's hands again.

saidinstouch said:

Unfortunately, as far as the FDA is concerned, they will never be allowed to change how cimzia is provided to the patient. With biologics there is no way to guarantee the same product everytime unless you follow the same procedure from start to injection everytime. It is one of the downsides of the medication due to limits of technology currently. Proteins are not like small molecules that can have their structures determined easily 100% of the time so the FDA simply follows the belief that if the process changes, you are generating a new drug which has to go through all stages of clinical trials again. Simply put, no company is going to spend the millions of dollars necessary in order go through clinical trials again when they already have a drug on the market.

I'm glad you are writing this journal as I am currently finding my Humira to be less than sufficient and the pegylation added to Cimzia makes it large enough to not be cleared by the kidneys, which is why you can get a smaller dose of it less often. It is basically the same as Humira in all other regards and has the same mechanism of action as Remicade, it is just a humanized MAb rather than chimeric(like remicade) which is a good thing.

Hopefully you'll get good results from the treatment and I wish you good luck with it .

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I believe this is the same reason why there will never be any cheaper, generic versions of the biologic drugs available for us.

Jeff D. said:

It could take a few months to see the results from the dilation. I thought it was supposed to be an immediate kind of thing.

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I was talking about Cimzia as that's what I was told with Humira. But I did see fairly quick, 3weeks, results from Humira. I'm not sure about the dilation.

That is exactly the reason you don't see biogeneric drugs the same way you see flagyl->metronidazole. There just is no real way to quickly and easily show the protein you made is exactly the same and functions the same way every time. With drugs you can simply form a crystal and solve the structure and know that it is exactly what you want it to be. I doubt they will ever be thinning the medication because of this. Additionally, it sounds like the medication was lypophilized which is essentially a freezing process to increase the shelf life of the medication. This is where the difficulty of remixing the medication comes in. Anyone who has had remicade has seen the long process it takes to prepare the IV bag...this is for the same reason. It is possible however that they might be able to develop a delivery device that is premixed that somehow deals with the problem rather than a formulation change. If this were to happen, then basically you could maybe have a pen like humira.

I would be surprised if it were ever thinned out unless it was made dilute though due to the fact the pegylation they added is specifically designed to make the the protein larger than the size your kidneys can filter out. This is how the half life in your body has been increased in cimzia, but I have a feeling it is also the source of viscosity they haven't been able to correct. Be somewhat wary of what your doctor says as they may not have a ton of experience on the matter. Your best bet would be to do some research on the FDA's policies yourself or talk to someone who has been in the biopharmaceuticals business.

I asked the nurse about it today and they are going to be asking the GI who did the research on Cimzia to let me know about the thinning of the medication. She did not believe that it would change anything and she thinks it will be relatively soon that a pen will be able to deliver the medication.

I just got my second dose of Cimzia and it was a breeze. It hurt a little more but I think it was just the spot she picked.

Yeah a pen delivery system is more likely than thinning in this case. Either way, as long as you are able to deliver it yourself its always more convenient than having to have someone else do it.

I was on Remicade and it did almost nothing for me the second time around. Cimzia with the aid of 6mp has helped me the most. I have never taken Humira before. I'm sorry you are sick of the meds. I don't think the Cimzia will help much with the scar tissue as it doesn't help me with that but it has put me into remmission. I hope you feel better soon.

I'm glad it helped. It can't treat the scar tissue but it had put my Crohn's to virtually nothing. I hope Mike does well on it. It seems to have a high success rate at my GI's office.

So, is it a good idea to perform this dilation?