EU Panel Concludes Negative Opinion For UCB's Cimzia

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njguy69
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Date Joined Jul 2006
Total Posts : 276
   Posted 3/24/2008 7:04 AM (GMT -7)   

ZURICH (Dow Jones)--The Committee for Medicinal Products for Human Use, or CHMP, Thursday said it has adopted a final negative opinion for Cimzia - or certolizumab pegol - from UCB S.A. (UCB.BT).

The CHMP concluded the re-examination of the negative opinion adopted on Nov. 16, 2007 for Cimzia, and said it confirmed its previous position.

Cimzia was intended to be used for reducing signs and symptoms and maintaining clinical response in patients with active Crohn's disease.


aka. uc veteran

Asacol - four a day
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ZenaWP
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Date Joined Aug 2007
Total Posts : 884
   Posted 3/24/2008 9:07 AM (GMT -7)   
I am currently on a clinical trial for Cimzia and think it has helped a tremendous amount (with the exception of winter-related arthritis flare). From what I heard back in November, the concern was that the induction period was longer than what the original report said it would be, so there was a concern over technicalities, but not over safety or effectiveness. I will do some research to see what the negative opinion was due to, as all the previous research was giving it positive reviews. I would love to know, though, if there is some horrible side effect, since I've been on it for about a year!
...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4


ZenaWP
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Date Joined Aug 2007
Total Posts : 884
   Posted 3/24/2008 9:22 AM (GMT -7)   
I just read that article and I believe the negative opinion was in regards to the problem I mentioned above...I am going off of what the clinical trial nurse is telling me and what research I've done on it in the past, as nothing I can find online is real specific. From what I know, when the information was first submitted to the FDA, or whoever it goes to first, the induction phase for the drug was listed as one thing. In the clinical trials, they have been using a longer induction phase. So, there is concern that the induction phase is longer than what was originally reported and they are requiring more clinical trials to be conducted. That article, and all others I've read, said that the clinical trials do show the drug to be effective. And, the side effects discovered so far are not any different than those with other biologicals (injection site reactions, infections, etc.). So, I wouldn't let that one line about the negative opinion disappoint anyone that this isn't going to be an effective treatment option in the future...it will just take longer than originally expected before it is available on the market.
...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4


Writer
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Date Joined Aug 2006
Total Posts : 443
   Posted 3/24/2008 9:24 AM (GMT -7)   
Don't know what they based the decision on, but I would think a big factor would be that the one big randomized clinical trial of this drug found that remission rates were no higher than they were with a placebo. Hard to justify approving a drug with potentially severe side effects on the basis of that evidence. Response (that is, improvement, but not to the point of reaching remission) was better than placebo, but response is a very weak endpoint compared with remission.

ZenaWP
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Date Joined Aug 2007
Total Posts : 884
   Posted 3/24/2008 11:54 AM (GMT -7)   
Writer, where did you get that information from (about remission rates not being any higher than with placebo)?  I researched the drug over a year ago and have done so periodically since and have always read that remission rates were significantly higher than with placebo.

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


Writer
Regular Member


Date Joined Aug 2006
Total Posts : 443
   Posted 3/24/2008 1:20 PM (GMT -7)   
Zena,

See this abstract of an article that appeared in the New England Journal of Medicine:

http://www.ncbi.nlm.nih.gov/pubmed/17634458?ordinalpos=27&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

The primary endpoint was response (a weak end point, as I mentioned), but they did evaluate remission.

ZenaWP
Veteran Member


Date Joined Aug 2007
Total Posts : 884
   Posted 3/25/2008 5:54 AM (GMT -7)   
Thanks, Writer. I had not come across that article before and it included more and different information than what I've seen before. I was especially interested to see the % who developed antibodies to it (8%), as I had never seen anything about that before. Well, regardless of what the different % I read in regards to remission and response are, I know that it has helped me a great deal. I'm afraid I will develop antibodies, if I haven't started already (it could just be a winter related arthritis flare), but I am glad for the year that I have felt much better since being on it. I hope they end up getting better results with the new group of clinical trials they are being required to do (although other articles I read gave higher rates of response and remission than this article).
...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4


Writer
Regular Member


Date Joined Aug 2006
Total Posts : 443
   Posted 3/25/2008 7:00 AM (GMT -7)   
This was the other big randomized, placebo-controlled study.
 
 
The results do look better, but remember that this study only included patients who showed at least some response during the first six weeks of treatment, so the results were achieved in a highly selective treatment population of good responders to the drug, not in an unselected patient population. Doing a little long division shows that of 668 patients who began the study, 31% (205) ultimately achieved remission on the drug, compared with 124 (19%) with the placebo. Regulatory agencies have to consider whether a drug is sufficiently more effective than a placebo to justify the costs and risks that taking it would involve. It would be great to have another randomized, placebo-controlled study of this drug that used remission as the primary endpoint so that we could find out more accurately just how effective it is. In any case, I'm glad it seems to be working for you.

ZenaWP
Veteran Member


Date Joined Aug 2007
Total Posts : 884
   Posted 3/25/2008 9:09 AM (GMT -7)   
Thanks for the articles, Writer.  This looks more like the results I've read in other articles.  And, it looks more like the trial I am in, where they use CDAI to measure response to the drug.  The other article mentioned CRP levels only.  In my trial, "remission" is once your CDAI gets to a certain number (don't remember what it is), whereas "response" means that your CDAI decreased 100 points from what it started at (yet it could still be higher than the remission number).  I think it would be hard to base the results solely on people achieving remission, as some people may start out with a relatively low CDAI (as I did...I was clinically in remission when I started the trial) and others start out with an extremely high number.  Wouldn't seem accurate to take those two people and base the effectiveness of the drug on them both achieving remission, when one was already there (but still improved 100 points) and the other was so far from it to start with that they didn't reach it, but still improved a great deal.  We'll see what they use in the other trials that they are having to conduct.          
...rejoice in our sufferings, because we know that suffering produces perseverence; perseverence, character; and character, hope.   Romans 5:3-4

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