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Upadacitinib clinical trial for UC

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Ulcerative Colitis
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barnsbury
Veteran Member
Joined : Jan 2006
Posts : 534
Posted 11/22/2017 6:06 AM (GMT -8)
Hi all

I am 4 weeks into a placebo controlled clinical trial of Upadacitinib (ABT 494) for my UC.

I am finally starting to see some difference. Few less BMs. But still am flaring.

I was wondering if anyone else is on this trial ?
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ks1905
Veteran Member
Joined : Sep 2005
Posts : 6420
Posted 11/22/2017 9:16 AM (GMT -8)
Is this your first JAK-Inhibitor biological? Out of curiosity, did you consider Xeljanz? You may have been able to get it off-label, it is also a JAK-inhibitor and you'd not had to of risked getting a placebo.
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barnsbury
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Joined : Jan 2006
Posts : 534
Posted 11/22/2017 9:36 AM (GMT -8)

ks1905 said...
Is this your first JAK-Inhibitor biological? Out of curiosity, did you consider Xeljanz? You may have been able to get it off-label, it is also a JAK-inhibitor and you'd not had to of risked getting a placebo.

Hi KS - Thanks for your reply. I had never heard of Xeljanz. What is the difference between that and Upadacitinib? I am in the UK, so I doubt it would be available here.

I have another colonoscopy in 4 weeks which will assess whether I have healed and I will re randomised at that stage depending on the scope results.
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ks1905
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Posts : 6420
Posted 11/22/2017 9:54 AM (GMT -8)
Xeljanz has been used for the last 5 years for RA. They will soon start using it for IBDs, it is currently being used by some UC'ers on HW.

/en.wikipedia.org/wiki/Tofacitinib

They are both orally administered.
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barnsbury
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Joined : Jan 2006
Posts : 534
Posted 11/22/2017 11:03 AM (GMT -8)

ks1905 said...
Xeljanz has been used for the last 5 years for RA. They will soon start using it for IBDs, it is currently being used by some UC'ers on HW.

/en.wikipedia.org/wiki/Tofacitinib

They are both orally administered.

OK. It seems the drug I am trialling is very similar but it more selective - blocking JAK-1 only. Resulting in fewer side effects.
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ks1905
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Posted 11/22/2017 12:11 PM (GMT -8)
Part of the reason I asked is because of the debate about if the 2nd biological you try is less effective than the first. So if you try Remicade first and then you move on to the 2nd Anti-tnf like Humira, it is less effective than Remicade. I was wondering if that worked the same for JAK-inhibitors as it does with Anti-tnfs biologicals.
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barnsbury
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Joined : Jan 2006
Posts : 534
Posted 11/23/2017 2:36 AM (GMT -8)

ks1905 said...
Part of the reason I asked is because of the debate about if the 2nd biological you try is less effective than the first. So if you try Remicade first and then you move on to the 2nd Anti-tnf like Humira, it is less effective than Remicade. I was wondering if that worked the same for JAK-inhibitors as it does with Anti-tnfs biologicals.

I didnt know about the biologics becoming less effective as you try them...

Remicade never worked for me. But, after trying it, I had a 7 year remission with Vedolizumab.

I was reading about Xeljanz last night. Interesting that in some of the reports it states that patients have significant improvement in UC after only 3 days of treatment. That is incredible. No drug has ever worked that fast for me. And I have been on pretty much all of them. Not even pred. It took at least 2 weeks before I noticed any difference on my current trial drug. Vedolizumab took months for any noticeable improvement...
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iPoop
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Posted 11/23/2017 5:42 AM (GMT -8)
The odds that you are refractory (non-responsive) to all UC medications increased as you fail a 1st, 2nd, and 3rd biologic.
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barnsbury
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Joined : Jan 2006
Posts : 534
Posted 11/23/2017 6:51 AM (GMT -8)
All my UC hospital reports state I am refractory to treatment. I only have clinical trials left for me now.
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iPoop
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Posts : 16473
Posted 11/23/2017 7:16 AM (GMT -8)
How bad are your UC symptoms and your quality of life? Any plans for surgery should the Upadacitinib trial fail?

We've had many posters go through surgery for their UC, do well and wish they'd have done it sooner!
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barnsbury
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Joined : Jan 2006
Posts : 534
Posted 11/23/2017 7:26 AM (GMT -8)
The last 12 months have been utterly miserable. Flaring horribly. I talked with my GI and we agreed that if this trial fails me then we would have to go down the surgery route. I have been on pred way too much.

But, I remain hopeful with this trial. My BMs are down from 15 a day to 4.
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mapesg
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Joined : Dec 2017
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Posted 12/25/2017 5:20 PM (GMT -8)
Barnsbury, how are things going?

After a ton of hoops and delays I just started a Upadacitinib trial 4 days ago here in the US. I’d guess it’s the same trial.

I’m 99% sure I’m on real drug. Not placebo. As I’m seeing changes starting on day 2 (crazy). So far it’s more formed stool (still small and broken up. But a lot better then near constant D). And less blood.

Having some discomfort I attribute to the more formed stool. Think my poor beat up colon isn’t quite ready for solid stuff.

Still a lot of trips and wakes ups in the night (I’ve been running about 10-15 trips a day, even with some Imodium to help me manage work during the day). But crossing my fingers that things keep improving. Hope you are seeing some relief.

Quick background: UC dx summer 2016. Constant flare since then. Humira started to help late 16’ but developed antibodies. Mesalamine drugs and even prednisone haven’t seemed to do much. Remicade helps some but my body washes it out in about 2 weeks. Insurance would only go for every 6 weeks. So taking a shot at a Christmas miracle with this study.
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notsosicklygirl
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Joined : Dec 2008
Posts : 17888
Posted 12/25/2017 7:13 PM (GMT -8)
I had surgery because I was refractory and it was the best thing I've done for myself for so many reasons. Not to say it's some kind of miracle, because it's not, but I've enjoyed the holidays very fully, I ate what I wanted, spent zero time dealing with doctors, spent zero money on drugs (I never do now), I do what i want, when I want. life is good. I know surgery isn't what you want, but if things don't work out with the trials, know there is hope for you to live a good life. I remember when I was initially diagnosed, I read all the worst cases, and I HOPED I would NEVER end up where I am, and here I am post-surgery, living better than I did with UC. Not to say you should jump up and wish for it, but please don't feel like it's the end. It's often the beginning of something better. Happy holidays smile
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barnsbury
Veteran Member
Joined : Jan 2006
Posts : 534
Posted 12/28/2017 2:24 AM (GMT -8)

mapesg said...
Barnsbury, how are things going?

After a ton of hoops and delays I just started a Upadacitinib trial 4 days ago here in the US. I’d guess it’s the same trial.

I’m 99% sure I’m on real drug. Not placebo. As I’m seeing changes starting on day 2 (crazy). So far it’s more formed stool (still small and broken up. But a lot better then near constant D). And less blood.

Having some discomfort I attribute to the more formed stool. Think my poor beat up colon isn’t quite ready for solid stuff.

Still a lot of trips and wakes ups in the night (I’ve been running about 10-15 trips a day, even with some Imodium to help me manage work during the day). But crossing my fingers that things keep improving. Hope you are seeing some relief.

Quick background: UC dx summer 2016. Constant flare since then. Humira started to help late 16’ but developed antibodies. Mesalamine drugs and even prednisone haven’t seemed to do much. Remicade helps some but my body washes it out in about 2 weeks. Insurance would only go for every 6 weeks. So taking a shot at a Christmas miracle with this study.

Hi mapesg

Good to hear from someone else on this trial smile

I can't believe how quickly you responded to the drug. It took me at least 3 weeks to see any major improvement. It does sound like you are on the active drug. Well, I have now completed the intial 8 weeks of the trial and I had my 2nd trial colonoscopy last week. Although there was still quite bad inflammation in the left side of my colon, the rest of my colon had healed significantly. Which is great news.

So I was categorised as a "responder" to the treatment and moved into Substudy 3 and re-randomised. I have a 50/50 chance of real drug or placebo on this arm of the study. Its been a week tomorrow since I started on this and I havent felt any worse so I am really hoping that I stayed on the real drug.

My BMs per day are around 4 with no blood and rarely any mucus. Urgency is still there, but I have that even when in remission due to massive scarring from repeated UC flares over the last 17 years.

My abdominal pain has mostly gone too. And I no longer run to the toilet all night.

Are you on any steroids? How are you feeling now? Have you experienced any side effects? Please keep me updated on how you go.

Take care
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mapesg
New Member
Joined : Dec 2017
Posts : 17
Posted 12/29/2017 8:02 PM (GMT -8)
Barnsbury,

Great to hear you are doing well enough to continue on the trial. Keep us posted!

For me this it’s now been a week. Still impressed by how fast this med has kicked in. Down a few more BMs since my last post; thankfully particularly in the night doing better. A few wake ups still but feels like I’m getting real sleep again. Small bit of blood with most trips but not bad at all. Haven’t noticed any side effects. Feeling good by my standards.

I’ve been holding on 10mg prednisone for a few months now. Looking to hopefully tapering that off at the end of the 8 week trial (I think that’s how it works. If I’m deemed a responder we go to the extension study and taper pred).

Still plenty more room for improvement. So hoping this positive trend continues. But also feeling very lucky right now. I’ll keep y’all posted on progress.
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mapesg
New Member
Joined : Dec 2017
Posts : 17
Posted 2/14/2018 12:43 PM (GMT -8)
Barnsbury,

How are you doing? Looks like I’m following a similar route as you. Deemed a responder, re-randomized. Crossing my fingers I’m getting the real drug (just started yesterday so too early to have a guess).

Scope at about 6 and a half weeks in found that my deep ulcers had cleared up. Still a total mess down there but they are saying they see a lot of signs of healing.

Down to about 4 BMs a day. I’d be content to stay at that rate. I still have blood here and there. And the quality of my stool varies quite a bit. I am being looser with my diet though and that seems to correlate wth some of my rougher bathroom trips. But even the bad trips seem a lot better then before the trial.

Hoping for more improvement. But if I had to stay where I’m at I’d take it. Very livable. That’s nice to say. And... hopefully I’m not on placebo. They can bump me to an open label study where I get real drug if I start to go downhill after something like 4 weeks. So I’ll be on the drug one way or another eventually.

Hope you are doing well.
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mapesg
New Member
Joined : Dec 2017
Posts : 17
Posted 2/14/2018 12:45 PM (GMT -8)
Oh and just starting Pred taper (7.5mg this week, 5 next, then 2.5). So that’s another fun variable to add to the mix. But looking forward to being off pred (been on it since August 2016!). My skin is still a mess and I blame pred. Time will tell.
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Crispix
Regular Member
Joined : Apr 2016
Posts : 63
Posted 2/14/2018 3:07 PM (GMT -8)

iPoop said...
The odds that you are refractory (non-responsive) to all UC medications increased as you fail a 1st, 2nd, and 3rd biologic.

I’ve seen this stated a few times here. What is considered “failing a biologic”? Is it just people who never responded at all to the biologic? Or is it still considered failing the drug, if it eventually loses its effectiveness over time?

If anyone knows the answer to this, I’d love to know, thanks!
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iPoop
Forum Moderator
Joined : Aug 2012
Posts : 16473
Posted 2/14/2018 4:39 PM (GMT -8)
Failed a biologic means:
1.) Never got a positive response.
OR
2.) Lost response
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barnsbury
Veteran Member
Joined : Jan 2006
Posts : 534
Posted 2/15/2018 6:32 AM (GMT -8)

mapesg said...
Barnsbury,

How are you doing? Looks like I’m following a similar route as you. Deemed a responder, re-randomized. Crossing my fingers I’m getting the real drug (just started yesterday so too early to have a guess).

Scope at about 6 and a half weeks in found that my deep ulcers had cleared up. Still a total mess down there but they are saying they see a lot of signs of healing.

Down to about 4 BMs a day. I’d be content to stay at that rate. I still have blood here and there. And the quality of my stool varies quite a bit. I am being looser with my diet though and that seems to correlate wth some of my rougher bathroom trips. But even the bad trips seem a lot better then before the trial.

Hoping for more improvement. But if I had to stay where I’m at I’d take it. Very livable. That’s nice to say. And... hopefully I’m not on placebo. They can bump me to an open label study where I get real drug if I start to go downhill after something like 4 weeks. So I’ll be on the drug one way or another eventually.

Hope you are doing well.

Hello mapesg

Good to hear from you and glad to hear that you are doing well.

Well a fair bit has happened since last time. After I got re-randomised, my symptoms started to slowly worsen. After around a week or so, the number of BMs went up and I was having to run into shops to use the toilet when I was out and about which wasnt the case before.

Also, the (mild) side effects that I was getting before stopped. (Strange dreams). Then the abdominal pains came back, etc. So, I was sure I was moved onto placebo. So, after 6 weeks I was moved onto the open label. You need to have 2 "unscheduled loss of response" appointments 2 weeks apart to be eligible for open label.

I have been on open label 15mg for 10 days now, and things are improving again. Some days I only have 2 BMs with no blood, which is amazing. Though today i had 4. So, its up and down but its definately improving. Also the strange dreams came back! Have you experienced any side effects?

It is deeply disappointing that my healing was interrupted with the placebo and I moved backwards just when I was doing so well. But, that cant be helped. I hope you manage to avoid placebo.

There are 3 of us on open label at my hospital now. Also, I think your steroid taper is a bit too fast, I could never come down that fast. But, then I have been on steroids for most of the past 18 years and now my adrenals are shot. I would drop by 1mg a month after 10mg and then at 5mg I switch to hydrocortisone which has much shorter half life than pred and makes taper easier. Its what worked for me last time.

Best wishes, keep us posted on your progress.
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Crispix
Regular Member
Joined : Apr 2016
Posts : 63
Posted 2/15/2018 9:47 AM (GMT -8)

iPoop said...
Failed a biologic means:
1.) Never got a positive response.
OR
2.) Lost response

Yikes. That’s kind of scary to me. It seems a lot of people end up eventually having to switch biologics at some point. I’d hate to think that eventually there would be no more medication options available. Anyways, thanks for the info!
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iPoop
Forum Moderator
Joined : Aug 2012
Posts : 16473
Posted 2/15/2018 1:21 PM (GMT -8)
No reason to be scared. There's new biologics every year or two. Some have been on remicade for 8-10, or more years without issue. Same will go with newer ones like entyvio. in the end, only 20-ish percent of us ever need a surgery, while 80% of us do not need it.
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mapesg
New Member
Joined : Dec 2017
Posts : 17
Posted 2/23/2018 12:04 PM (GMT -8)
Barnsbury,

Glad you are improving again, but sorry you had to go through the placebo weeks. I've seen a bit of an up-tick it BMs since I was re randomized (which was roughly 10 days ago), one or two extra a day compared to prior. At first I jumped to assuming placebo but I'm not so sure now. If I had to guess I'd say I may just be on a lower dose now. I've been going through a lot this past week, including prednisone taper, switching jobs, drinking beer and eating a bit recklessly (to celebrate the new job / deal a bit with stress).

So considering the stress of the job swap, the taper and bad diet choices; an extra trip or two a day makes sense. Going to clean up the diet and hopefully settle the stress a bit as I transition to the new job and see where I land in a week or so. Glad there is at least a fall back of going to open label 15mg if I continue to decline though.

Pred taper: at 5mg for a few days now, going surprisingly well, can't point at anything other then maybe the extra BMs that I'd call a tapering side effect.

Study med side effects: Can't say I can identify any, no strange dreams or anything like that. That's an interesting one though; maybe you're sleeping better and that's affecting your dream? Just a thought.
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Spring
Veteran Member
Joined : Jan 2017
Posts : 544
Posted 2/23/2018 6:44 PM (GMT -8)
Thanks for sharing details. This medicine sounds hopeful. I just took my last loading dose of Entyvio today. I can't say I have seen any improvement from it yet.
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barnsbury
Veteran Member
Joined : Jan 2006
Posts : 534
Posted 2/25/2018 3:33 AM (GMT -8)
mapesg - I too hope you havent been moved to placebo. But, you will know within the next couple of weeks or so. If you are out and about and you have to rush to find a toilet, then chances are you now on placebo...

Spring - It took me several months of infusions of Enyvio before I saw any improvement, so I wouldnt worry about it. Just give it time.
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