My Second Abatacept Open Label Study Treatment

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Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 1/10/2008 8:42 PM (GMT -7)   
For those that have been following my Abatacept study for UC, I had my second open label treatment yesterday, 4 weeks after my first. I arrived at the hospital about 1:00pm and immediately saw the study coordinator. She gave me $20 for this visit but did not require any blood, urine or stool samples like previous visits. She called the pharmacy to have them prepare the Abatacept. I had no improvement in my symptoms. I have had 7 or 8 urgent BMs per day with blood on most of them.

I waited another 15 minutes to see the study doctor. He performed a physical checkup and answered a few questions. The first 3 treatments of the open label study were 2 weeks apart then 4 weeks after that. I had a total of 4 treatments in the placebo controlled study before entering the open label study. I asked him why I didn’t have the first 3 treatments of the open label 2 weeks apart and he said that since we don’t know if I was on the placebo or not they won’t give me them 2 weeks apart because I could be overdosed if I had the real thing and not the placebo.

If the treatment works for me he normaly expects improvements in 3 to 4 treatments. That is why the placebo part of the study had 4 treatments. Now that I’m on the open label it may take longer if I had the placebo because I didn’t have the loading doses at 2 weeks apart. The doctor feels it could take 4 or 5 treatments to see an improvement. If I actually had the real treatment and not the placebo then there is a good chance the medication will not work for me. I will just have to wait and see.

I then had lunch and met the study coordinator at the infusion centre at 2:00pm. After taking my vitals (temperature, blood pressure and heart rate) she connected the IV line and started the infusion at 2:15pm. The infusion lasted a half hour and I left the hospital after my vitals were taken again at about 3:00pm. My next treatment is scheduled for February 6.

Thanks for listening,
Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Allergic reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Currently in Abatacept trial - waiting for remision
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 29842
   Posted 1/10/2008 10:29 PM (GMT -7)   
Hi Paul...I sure hope this one will show some improvement...rather than after the 3rd or 4th.

At least you're not getting any worse  nono
 
thanks for keeping us updated.
quincy


*Heather*Status: mini flare Dec 28... increased enemas to nightly
~diagnosed January 1989 UC (proctosigmoiditis)
~5ASA: Asacol (6 daily) + Salofalk enemas (increase for flares tapered to maintenance)
~Bentylol (dicyclomine) 20mg as needed
~vitamins/minerals/supplements 
~Probiotic 3(Natural Factors Protec) bedtime + 1 (Primadophilus Reuteri) occasionally
~multi-digestive enzymes as needed ....bromelain 1 - 2x daily
~Ranitidine,Pariet (reflux) Effexor XR 75mg;  Pulmicort/Airomir (asthma)
~URSO for PSC (or PBC) 500mg X 2 daily (LFTs back to NORMAL!!)
My doc's logic.. "TREAT (FROM)BOTH ENDS"  worth it !!!


Severin
Regular Member


Date Joined Oct 2007
Total Posts : 320
   Posted 1/11/2008 2:50 AM (GMT -7)   
Hang in there Paul. Don't expect a massive overnight change, from what I've read from other people its not like remicade where everything suddenly turns around. I had noticable results 15 days after the 4th infusion. The other patients I am in the trial with had results after the 3rd dose, but the first has chrons and colitis, and the other has extremely serious chrons - from what the doc has been saying, it seems to work faster for chrons people.

The only other thing of note, is that with all of us, results begin to manifest themselves 15 days after infusion like clockwork.

Again, I really hope you get the same or better results then we've had - the symptoms you describe seem less then the 14, 10 and 18 daily toilet trips the three of us are "enjoying".
"We are dreamers, shapers, singers and makers..." - Elric, elder Technomage
    - 2xColazide, twice a day; 1x6-mp twice a day; 1xAbatacept 10mg/kg per month;
    - 1xZinc per day, 2xScoop of Sustagen Sport per day;
    - 1xBIOCeuticals UltraBiotic 45 per day, 1xBIOCeuticals SB FlorActiv per day;
    - 1xHeaped teaspoon of Metamucil smooth orange powder 3 times a day.


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 1/11/2008 10:52 PM (GMT -7)   
Thanks Heather and Severin,

My symptoms usually vary from 3 to 15 BMs per day with severe urgency on every one. The last week has been fairly stable at 7 or 8. When they vary so much it is difficult to tell if I am improving. I will have a few days where I think things are getting better then all of a sudden they get worse again. It has been like this for more than the last 2 ½ years. It will take at least a week of improved symptoms to know if things are improving.
Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Allergic reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Currently in Abatacept trial - waiting for remision
 


Old Hat
Veteran Member


Date Joined Feb 2007
Total Posts : 5135
   Posted 1/12/2008 8:08 AM (GMT -7)   
Paul, when you write "severe urgency", it makes me wonder if the docs ever prescribed Cortifoam for you. (10% steroid rectal foam) It looks from your signature like you have tried the liquid steroid enemas, but not the foam. I know it's available in Canada because pb4 writes that she gets a lot of relief from using it. Dr. Daniel Present, a leading IBD gastro in the U.S., recommends applying it morning & night for at least 10 days at outset of treatment for UC. (Not a cure for severe UC, but it can boost healing in the rectum because it "stays put" after insertion!) Just a thought-- I wish you could get at least partial help from some of the conventional meds. Good luck with the continuing Abatacept tests & many thanks for keeping us posted. / Old Hat (nearly 30 yrs with left-sided UC ... [etc.])

UCinNC
Veteran Member


Date Joined May 2007
Total Posts : 528
   Posted 1/12/2008 2:41 PM (GMT -7)   
Hi Paul - if I am about to ask something you have addressed in an earlier post, please let me know and I will look for the post. but, I am wondering about this trial. first, is this drug a biologic? second, what is an open-label trial? thanks, and I hope you feel better soon. I hate the urgency component of this DD.
29/Female/NC
Pancolitis dx 3/07
12 Asacol/day
150mg Imuran/day (steroid dependent, reached this dose 9/07)
Various vitamins, a probiotic.


Severin
Regular Member


Date Joined Oct 2007
Total Posts : 320
   Posted 1/12/2008 6:36 PM (GMT -7)   
Paul L - I found the first thing I noticed when the drug started to kick in for me was not a change in the number of times per day, but the urgency reduced noticeably. Instead of needing to be on a toilet within 2 minutes, I found I had 5, and then 10 etc... Now I can get away with up to 40 minutes between the first rumblings and actually getting to the bathroom so long as i don't have to walk too far.

UCinNC - The drug is a fusion protein, which as far as I know is classed as a biologic. You can read more about Abatacept on Wikipedia. The trial is actually double-blind placebo controlled with an open-label component. This means that for the first part of the trial, you have no idea what they are putting in your veins and its luck of the draw as to what you get. At the end of part 1, you get evaluated and you either go into another double-blind maintenance part of the trial, or if you have not had any improvement, you go into the open-label component. open-label means you get 10mg of the drug per Kg of your body weight at each infusion.

I had my 7th open-label infusion on the 10/01 and this is the first one in which i am completely off the prednisone, and I am getting some formed stools for the first time in 2 years! Hope I'm not celebrating too early :-/

Best of luck to you all and I hope you get great results as well.
"We are dreamers, shapers, singers and makers..." - Elric, elder Technomage
    - 2xColazide, twice a day; 1x6-mp twice a day; 1xAbatacept 10mg/kg per month;
    - 1xZinc per day, 2xScoop of Sustagen Sport per day;
    - 1xBIOCeuticals UltraBiotic 45 per day, 1xBIOCeuticals SB FlorActiv per day;
    - 1xHeaped teaspoon of Metamucil smooth orange powder 3 times a day.

Post Edited (Severin) : 1/12/2008 6:39:03 PM (GMT-7)


dakotagirl
Veteran Member


Date Joined Apr 2006
Total Posts : 3402
   Posted 1/12/2008 8:05 PM (GMT -7)   
Paul - good to hear from you! I enjoy reading your updates :)

I really hope this works for you!
Pan-colitis and GERD diagnosed May 2003
 
Asacol 12 per day,  Azathioprine 75mg, Aciphex, Effexor XR, Forvia and a Probiotic
Osteopenia (hip and spine) from prednisone use.  Started Azathioprine because I was steroid dependent.
 
Co-Mod for the UC forum
Keep HealingWell running smoothly:  www.healingwell.com/donate


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 1/12/2008 8:54 PM (GMT -7)   
Yes Old Hat, I have tried Cortifoam. I guess I forgot to add it to my signature. It did absolutely nothing for me. The liquid enema tends to reach further up then the foam. My inflammation covers most of my left side colon which is too far up for foam or liquid to reach.

UCinNC, Severin answered your questions but I would like to add that Abatacept is a biologic like Remicade but instead of being a TNF blocker, Abatacept works on the T cells. When I was on Remicade I was tested for antibodies and Remicade levels. The tests showed that TNF blockers don’t work for me and because of that I didn’t qualify for the Humira trial. That is why I went into the Abatacept trial.

Severin, I’m glad you are improving. I hope it works just as well for me.

Thanks dakotagirl.
Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Allergic reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Currently in Abatacept trial - waiting for remision
 


Old Hat
Veteran Member


Date Joined Feb 2007
Total Posts : 5135
   Posted 1/13/2008 4:05 PM (GMT -7)   
Sorry, Paul, that Cortifoam doesn't help you at all. I'm aware of its limitations, as well as Cortenema's, too, because I get UC in descending colon off & on. When it's "on", the only help comes from oral med or a few months on daily Cortenema where the systemic effect kicks in. Since you have allergy to 5-ASAs, I'm wondering if you've been tested for food or chemical allergies in addition. Do you react to caffeine? Those things can contribute to urgency. Of course I'm hoping that what Severin wrote above re Abatacept will apply in your case & give you real relief soon. All best wishes! / Old Hat
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