FDA Approves Cimzia....

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njguy69
Regular Member


Date Joined Jul 2006
Total Posts : 276
   Posted 4/23/2008 11:02 AM (GMT -7)   
http://www.reuters.com/article/companyNews/idUSN2231466020080422
aka. uc veteran

Asacol - four a day
6 MP - 1 tab. a day
Remicade - every eight weeks.


njguy69
Regular Member


Date Joined Jul 2006
Total Posts : 276
   Posted 4/24/2008 3:36 AM (GMT -7)   
ttt
aka. uc veteran

Asacol - four a day
6 MP - 1 tab. a day
Remicade - every eight weeks.


jid
Regular Member


Date Joined Apr 2005
Total Posts : 103
   Posted 4/24/2008 7:07 PM (GMT -7)   
I heard about this yesterday from the study coordinator at the dr's office that I go to. She said that this biologic had very strong success in the study patients they had. I don't know anything about the details but she was really excited that there is _another_ choice for us CD patients.

does anyone have experience with this drug?

ZenaWP
Veteran Member


Date Joined Aug 2007
Total Posts : 884
   Posted 4/29/2008 12:23 PM (GMT -7)   
jid, I am currently in a clinical trial for Cimzia.  I've responded to this drug but, honestly, my Crohn's was clinically in remission when I started the trial.  However, my Crohn's Disease Relative Index, or the method they use to evaluate results, has improved a lot since starting the drug a little over a year ago.  It also helps with the arthritis, but I haven't seen complete improvement.  Still, it works much better than Remicade did for me and I haven't had any reactions other than injection site (I got a whelp a couple of times, which is the worst injection site reaction out of anyone in the study at this hospital).  My trial doctor told me yesterday that they plan on continuing the trials for about 5 years so they can watch the long term effects.  It's just nice getting free medication that actually works and getting free bi-weekly or monthly doctor visits/labs, etc.  Not sure how much the drug will cost on the market, since it is new. 
...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4


gachrons
Veteran Member


Date Joined Mar 2007
Total Posts : 4527
   Posted 4/29/2008 5:14 PM (GMT -7)   
Hi Zena Did you do Hum. before trying this med? Is it given by injection or IV ? Thanks for giving us some info on how your doing.How long have you been on it ? What requirements do they have before starting it? Thanks lol gail

CrazyHarry
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Date Joined Mar 2006
Total Posts : 1034
   Posted 4/29/2008 7:42 PM (GMT -7)   
the side effects they said this could cause were down right scary. and it causes D and abdominal pain - great! now you dont know if it is working and those are side effects or if the disease is progressing. any thing that the FDA strongly cautions has got to be super bad imho as most of the stuff they ok is already pretty gnarly (ie - the merck problems etc and now that those cholesterol drugs dont work at all).
Crazy Harry

---------------------------------------------
Crohn's since 1993 (17 yrs old then)
surgery in July '05 - removal of 2 inches at ileum and 8 inches of sigmoid colon (had fistula into bladder)
Nov '05 developed colonic inertia; July '06 told i needed ostomy surgery
began maker's diet in August '06 - now feeling the best ever with no symptoms of colonic inertia and i kept my colon
med free as of 10/31/07


CrohnieYogi
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Date Joined Oct 2006
Total Posts : 367
   Posted 4/30/2008 7:03 AM (GMT -7)   
Take the side effects/warnings in stride.  They are the same as humira and remicade.

ZenaWP
Veteran Member


Date Joined Aug 2007
Total Posts : 884
   Posted 4/30/2008 7:30 AM (GMT -7)   

Hi all, Cimzia is similar to Humira, from what I've been told by my GI and the clinical trial doctors/nurses.  My GI thinks that if Cimzia has helped, Humira should help also, but I did not try Humira prior to starting Cimzia.  I was on Remicade previously and had to stop due to allergic reactions and loss of response.  Cimzia is given via subcutaneous injection. 

I get two shots every two weeks.  I get them in my legs just because I initially had injection site reactions and didn't like having whelps on my arms where everyone can see.  Stomach is also an option, but we decided against it due to a lack of stomach fat.  =) 

Crazy Harry, not sure what you are referring to, as the side effects to Cimzia are the same as the side effects to Remicade, Cimzia and other similar drugs: injection site reactions, upper respiratory and other infections, etc.  I have not experienced anything other than injection site reactions and those stopped after the first few months. 

I didn't have an issue with D when I started the trial (mine has always been C), but have heard that others in the trial with more severe symptoms than my own have responded very well.  Not everyone has responded 100%...most have improved a lot but still have bad weeks every once in a while.  Only a few have dropped out of the study I'm in at UofL hospital and those dropped out because they had surgeries, other things happen and just couldn't get to the study every other week.  I was told that no one dropped out due to a lack of response. 

I have been on the trial since February 2007.  I am now in the long term (maintenance) phase of the trial.  In order to qualify for the trial, you had to have lost response to other drugs (like Remicade) and you had to have Crohn's bad enough to have a certain Crohn's Disease Activity Index, a number they use to determine how bad your disease is.  This is also how they determine if you are responding or not.  You keep a daily journal of your # of D, severity of abdominal pain, overall feeling of wellness, fevers and if you take any meds for D.  Then, when you go for your appointment, they also ask you about your history with arthritis, fissures, absesses, eye problems, etc. over the last two weeks and calculate everything in together to get a score.

Now that it is available on the market, I don't know if there will be any requirements before insurance will cover it, like if they require that you try Humira or Remicade first, since I'm sure Cimzia will be expensive at first.  I guess it will depend on the doctor and the insurance company as to how they feel about trying it before trying the others.  I would definitely give it a try if you lost response or had reactions to Remicade...it's much better and much more convenient and quicker, in my opinion, but I don't know how much difference there is between it and Humira.  My trial nurse just knew the technical differences but didn't know how they worked in your body and I didn't ask the doctor to explain that. 

Sorry for the long post.  Hope this answers some questions.  If there is anything else that you want to ask about it, let me know.  If I don't know the answer, maybe I can make a list to ask the doctor the next time I see him (only see the dr. every month).  Thanks.

 


...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 4/30/2008 7:39 AM (GMT -7)   
Thanks ZenaWP. I am curious about the doseage. You mention that you are taking two shots every two weeks. What was the approved dose? I thought it was one subC shot/month?
--39 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--stuck on methylprednisolone, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08
--single mom to 10-year-old girl


ZenaWP
Veteran Member


Date Joined Aug 2007
Total Posts : 884
   Posted 4/30/2008 7:58 AM (GMT -7)   
sr5599, each shot is 200 mg, so I get 400 mg of the shot every two weeks.  You are correct in that most of the information I've seen online says the shots are given once a month.  The trial I'm on has always been 400 mg (2-200 mg shots) every two weeks.  Not sure why there is a difference there.  I will start a list and send it to my clinical trial nurse...maybe she can find out some of the answers sooner than I see the dr. again.  Thanks for asking that question...I've always wondered about that also, so I'm sure others wonder also. 
...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4


CrohnieYogi
Regular Member


Date Joined Oct 2006
Total Posts : 367
   Posted 5/1/2008 5:21 AM (GMT -7)   
I found the website.  Not sure if I can type it out due to the rules, but it is the product name .com.  Maybe this will answer some of our questions.
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