My Second Abatacept Open Label Study Treatment

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,

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".

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.])

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.

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.