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Is anyone participating in the current Phase III Stelara (Ustekinumab) study?

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Ulcerative Colitis
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Posted 4/17/2016 5:56 AM (GMT 0)
Hi,

Unfortunately Remicade stopped working so we have discontinued. I'm currently in a fantastic Prednisone "remission" which has given me my life back but we all know how that goes. I am enrolled to start soon-ish in this study of Stelara:

https://clinicaltrials.gov/ct2/show/NCT02407236

Anyone else already participating? Any results/news?

Cheers
Posted 4/17/2016 3:44 PM (GMT 0)
I know ks1905 is taking it for pouchitis, but not for UC, so his results probably wouldn't be too relevant. I have one girlfriend in Canada who was taking it for UC but hasn't had result - she's moving on to surgery. My GI told me it wouldn't likely be worth wasting my time on it because I had absolutely no response to anything else. I guess at a certain point, for people who are really resistant to treatment, it just becomes more lost time. I didn't want to lose all that time trying another medication.

I feel like there was a post about stelara a few weeks ago and there were some people who were doing well or were very hopeful.
Posted 4/17/2016 5:40 PM (GMT 0)
I feel similarly - I've spent enough time already waiting for things to work. And then there's the chance I'll get the Placebo, which would be just my luck. There are also some people on Reddit (Crohns, though) who have had good results. I guess it makes sense that there's not much information on it yet.

I'm prepared to take the leap of faith one last time and if it doesn't work out, time for surgery.
Posted 4/17/2016 10:55 PM (GMT 0)
I've taken 2 doses so far, I was in complete Remission within 2 days but it wore off in about 10 days. The next dose only worked for about 6 days and now I have to wait until my next dose 3 months.

I'm taking it off-label so my insurance company is paying for it so I'm not getting a Placebo. The problem is that they only approved the Psorisis dosage which is 45 mgs. My GI is working on getting upped to 90 mgs.

Before I started Stelara my GI said that we might have to play with the doses 90mgs or an IV.

If you try the study you'll probably know in a few days if you're getting the placebo or not.
Posted 4/18/2016 5:42 PM (GMT 0)
Thanks for the info Keith. No doubt if it works for me I'll be back in here raving about it
Posted 4/18/2016 6:33 PM (GMT 0)
I hope it works for you. I was really optimistic after the first few days because I felt so good. I slept great, easy to empty my pouch and I just overall felt better.

I think the current psoriasis dosage (45 mgs) is not strong enough for IBDs and that is what they are trying to determine with this study.

The thing with Stelara is that it is really expensive, my insurance company after their discounts pays $8,000 a pen (dose). I wonder what the IV would cost.

If you have the option then I'd try to get the larger IV dose, it seems IBD'ers need it.

My only side-effect was that I got really itchy for a few days like I did with Humira. I took a claritin for a couple of days and it went away.
Posted 4/20/2016 7:01 AM (GMT 0)
The study has two doses. From memory it is either a fixed dose of 130mg or a body weight dose of 6mg/kg. For me that would be about 360mg. Determined by lottery of course. The induction doses are all IV and then after 8-16 weeks responders get to continue, names go back in the hat and I believe either some or all subsequent doses are subcutaneous injections. I don't have the paperwork here with me but I'm pretty sure I got it right.
Posted 4/20/2016 3:02 PM (GMT 0)
So I'm getting about a 1/10 of the dose that I need if the trial dosing is correct. No wonder why Stelara only works for a week or two for me. But it is great for the 10 days that it works for me.
Posted 4/22/2016 5:41 PM (GMT 0)
My insurance company just called and they approved my increased dose to 90 mgs. Sometime next week I should have the extra dose to 90mgs.
Posted 4/22/2016 5:52 PM (GMT 0)
Awesome news Keith. I hope the larger dose keeps you well for longer so you can maintain remission between doses :)
Posted 6/27/2016 9:53 PM (GMT 0)
I had my Stelara randomisation yesterday. I was concerned about receiving Placebo but last night I had the familiar post-infusion sweats and today feel very much like I used to feel the day after a dose of Infliximab. It's hard to describe but I'm definitely drugged up on something and with a metallic taste that comes and goes.

Will post results, if any, as things progress.
Posted 6/27/2016 10:35 PM (GMT 0)
What dose did you get?

After talking to my GI he said the IBD Stellara protocol will most likely be IV loading doses and then 90 mg shots for the maintenance dose.

I got the psoriasis protocol, 2 loading doses at 45 mgs (week 0 and week 4) and then 45 mgs every 90 days.
Posted 6/28/2016 12:44 AM (GMT 0)
I don't know, all I could see was it was a 370ml IV bag. Hopefully the highest dose!
Posted 6/28/2016 2:31 AM (GMT 0)
hey kiwi,
I think we started remicade at the same time
it looks like it is not working for me, I did a test for antibody and levels. but we think there are antibodies
I want to try stelara because its anti-IL23 and i get excema in relation to my inflammation. it seems that people who get excema with ibd inflammtion make more IL23 so it seems like a good try.
stelara is probably easier for me to get now that the dx is crohns....
Posted 6/28/2016 2:58 AM (GMT 0)
Wow I didn't realise your diagnosis had changed. I've read quite a few Stelara success stories for Crohns - worth a shot for sure. For me it is a last resort as the only biologic approved for UC here in NZ is Remicade and I've failed it. It'll be surgery if this doesn't work. Trying not to think that far ahead though.
Posted 6/29/2016 3:21 AM (GMT 0)

ki-wi said...
Wow I didn't realise your diagnosis had changed. I've read quite a few Stelara success stories for Crohns - worth a shot for sure. For me it is a last resort as the only biologic approved for UC here in NZ is Remicade and I've failed it. It'll be surgery if this doesn't work. Trying not to think that far ahead though.

assuming that was no pun intended, but was worth a chuckle anyways
I am hoping it works for you
good luck!
Posted 6/29/2016 5:06 AM (GMT 0)

ki-wi said...
Wow I didn't realise your diagnosis had changed. I've read quite a few Stelara success stories for Crohns - worth a shot for sure. For me it is a last resort as the only biologic approved for UC here in NZ is Remicade and I've failed it. It'll be surgery if this doesn't work. Trying not to think that far ahead though.

For me, surgery has been so much better than drugs. Just my opinion, but try to think positive. It could give you a better outcome than dependence on drugs.
Posted 6/29/2016 6:53 PM (GMT 0)
Thanks for the advice. I'm almost only doing this to humour my doctor. I'm ready for surgery. Scared, but ready.
Posted 6/29/2016 7:31 PM (GMT 0)
Ki-wi,

Any response to the Stelara loading dose?
Posted 6/29/2016 8:54 PM (GMT 0)
Nothing yet

Edit: Unless lots of additional gas counts mad

Post Edited (ki-wi) : 6/29/2016 2:58:24 PM (GMT-6)

Posted 9/22/2016 7:10 PM (GMT 0)
An update if anyone's interested. The Stelara study has been a flop, a complete waste of about six months.
I didn't see any improvement at any stage. I'm pretty sure I didn't get placebo at Week 0, as I could taste the drug for a couple of days post-infusion. It caused sleep issues and about 48 hours of feeling "off", which was strikingly similar to how I would feel after a Remicade infusion. At week 8 I was deemed a non-responder and given a second dose - at least 90mg. Oh well, at least I've tried everything now. Surgery here I come. Scary and exciting.
Posted 9/22/2016 7:28 PM (GMT 0)
Oh
I'm sorry that this didn't work for you. Would have been amazing. But surgery can be liberating. It has its own challenges but puts most people with UC into what I call a surgical remission.
Do you have a date set for surgery?
Have you decided if you are doing perm illeosomy or pouch?
Posted 9/22/2016 7:29 PM (GMT 0)
Sorry it didn't work out. Yes, surgery is scary if that's where you're heading but I'm here to say from experience that it can also be a humongous blessing. Best of luck.....
Posted 9/22/2016 8:27 PM (GMT 0)
Stinks on stelara but at least you have a path forward. Definitely sounds like it's time to evict the darn belligerent colon that won't play by the rules, and finally have a good quality of life post-uc. You've been through a lot.
Posted 9/24/2016 3:28 AM (GMT 0)
I had surgery and I am around your age, I came through so easily. I hate to say that because it was HARD, especially the first step, but all in all, it was a couple weeks of discomfort, a lot of inconvenience, and it led to a whole new outlook on life. Well worth it for me. I didn't bother with stelara, my GI felt that with my history of no responding, it would have been more of the same, and it would have prolonged things, you know, even if I tried it and it worked, I'd be better off without my colon. I say that because a treatment generally works for a period of time. Surgery can be forever.
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