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New U.C. Drugs in the Pipeline

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Ulcerative Colitis
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Posted 1/28/2013 6:26 PM (GMT 0)
Found this summary on medscape.

Vedolizumab:
Gut specific biologic. Currently in phase 3. I actually called them and they told me they have no estimate as to when they will be seeking FDA approval. In the final phase of trials, so hopefully will be soon! Very effective with low side effects.

Budesonide MMX :
Enteric coated budesonide for moderate to severe left sided U.C. The last clinical trial showed that almost 50% of patients taking it were put in to remission! They are currently recruiting patients for another clinical trial. See here clinicaltrials.gov/show/NCT01532648
According to the trials so far, this drug does not suppress your adrenal system or have side effects like prednisone, and has even been shown to be effective for maintenance of remission. Of course prednisone fails on all three of those issues.

Uceris:
Another enteric coated budesonide pill. Already FDA approved and should be available this spring. For mild to moderate UC.

Tofacitinib:
Oral biologic with promising results, with up to 75% of patients showing significant improvement. Currently in late stage trials.

Two other injectable biologics are in the U.C. pipleline too, Adalimumab and Golimumab. No estimate as to when they might be available.
Posted 1/28/2013 7:01 PM (GMT 0)
Thanks CGK.  Seems somewhat hopeful--always like to hear about new drugs on the horizon (well a cure is better, but you know...)  Thanks for posting!

B

Posted 1/28/2013 7:51 PM (GMT 0)
HI CGK- Thanks for the info, I printed it off and when March comes I'll be going to see my Gi about that one drug Uceris. I would try the Budesonide MMX study too and I wrote them that I would. Hopefully something good comes of it! I would have to drive two hours to an office but that's ok with me.
Posted 1/28/2013 9:32 PM (GMT 0)
Do you have any knowledge of the side effect of Vendolizumab? I have been looking on google and have only been able to find MPL (but they have proven otherwise). Is there no cancer associate with Vendolizumab?
Posted 1/28/2013 9:51 PM (GMT 0)
There is a fairly in depth article on vedolizumab here:

www.gastro.org/journals-publications/gi-hepatology-news/GI_-_Hepatology_News_-_August_2012.pdf

The article said...
In addition, there was little difference between the vedolizumab and placebo groups in terms of adverse events, serious adverse events, and serious infections,said Dr. Feagan, professor of medicine at Western University in London, Ont.

Posted 1/28/2013 9:53 PM (GMT 0)

therearemiracles said...
HI CGK- Thanks for the info, I printed it off and when March comes I'll be going to see my Gi about that one drug Uceris. I would try the Budesonide MMX study too and I wrote them that I would. Hopefully something good comes of it! I would have to drive two hours to an office but that's ok with me.

Hopefully you get in. Keep us posted!
Posted 1/28/2013 10:21 PM (GMT 0)
Note on Budesonide: what I took for about three years wasn't enteric coated, and it did act systemically. I developed avascular necrosis and diabetes as well as osteoporosis. I hope the new stuff is better.
Posted 1/28/2013 11:01 PM (GMT 0)

C_G_K said...
Found this summary on medscape.
Tofacitinib:
Oral biologic with promising results, with up to 75% of patients showing significant improvement. Currently in late stage trials.

Two other injectable biologics are in the U.C. pipleline too, Adalimumab and Golimumab. No estimate as to when they might be available.

Tofacitinib is already on the market as Xeljanz for RA, as well as Adalimumab (Humira) which is approved for Crohn's and UC as of last fall, and Golimumab (Simponi) which is approved for RA. I've had all three offered to me off label by GIs.

We have a few members here who were in the vedolizumab trials with mixed results. I know UCWarrior took it for a while before his surgery.
Posted 1/28/2013 11:32 PM (GMT 0)
Great post.
Posted 1/29/2013 1:03 AM (GMT 0)
Actually, forget about Adalimumab, that's just Humira which was approved for U.C. last September.
Posted 1/29/2013 1:37 AM (GMT 0)
I thought entocort (budesonide) was enteric coated?

In any case, it does cause adrenal suppression from my experience.

Not sure about this new mmx one.
Posted 1/29/2013 2:16 AM (GMT 0)
Good post.

And stealth I beleive it is (if its the latest one that was approved).
Posted 1/29/2013 2:39 AM (GMT 0)
I wonder if the Budesonide meds are very expensive? I think entocort is out of range to people without insurance. It's such a shame that we would have to opt for prednisone because of money when something safer with less side effects is available.
Posted 1/29/2013 3:53 AM (GMT 0)
Budesonide is outrageously expensive. Even now that entocort tabs have gone generic, the cost is sky high.

As for adrenal suppression, here is what they said about Budesonide MMX:

From here: www.ncbi.nlm.nih.gov/pubmed/21122499
"Neither morning cortisol nor pituitary-adrenal axis was more frequently suppressed with Budesonide tablets than with placebo."

Efficacy:

Medscape Article said...
Budesonide MMX induced a rapid and significant clinical improvement in patients with left-sided UC.

As for maintenance of remission:
(From Medscape)
"budesonide MMX significantly prolonged the time to relapse. The median time to clinical relapse was more than 1 year in the budesonide MMX group compared with 182 days in patients who received placebo. Given that no other corticosteroid has been definitively shown to have a role in maintenance of remission in IBD, this data will need confirmation."
Posted 1/29/2013 2:51 PM (GMT 0)
I got a names of the two doctors doing it the area I would drive to, (two hours away) they are to call me back. I'm wondering so what if I get the drug and I go into remission, will they let me continue it or I have to get off of it because it's a study? Anyone know?
Posted 1/29/2013 3:06 PM (GMT 0)
 

Shan2013 said...
Do you have any knowledge of the side effect of Vendolizumab?

It's basically a reconfigured version of Tysabri that is allegedly safer. Tysabri is the drug that has killed many CD'ers and folks with MS during it's trials. But, the problems with Tysabri weren't discovered until a later point in testing than the vedo is at now, yet they know the vedo is safe? I wouldn't be convinced. Sounds like to me they want to get it to market. If that is what they are trying to do and just trying to lock in profits as soon as possible and they end up killing more people, here's to hoping they rot in hell.

Here's a negative endorsement of vedo from a researcher:

http://onlinelibrary.wiley.com/doi/10.1002/ibd.21078/pdf

Posted 1/29/2013 3:58 PM (GMT 0)
Sadly all biologics have potentially serious, even fatal side effects. That story about Vedo is from 2008, so not sure how relevant it is now.
Posted 1/29/2013 4:25 PM (GMT 0)
I talked to the nurse in the study for Budesonide MMX and she said she has to talk to the doctor who's running it because it's for those who are in remission and have a flare currently and on a 5ASA so she said I might not qualify since I've never been in remission.

Its a med you take only for 8 weeks no more and then it gets you into remission and you take the 5 asa after that and 5asa never really did work for me anyways.

I would have to go down state (2 hours away) 7 times in the morning and on a empty stomach they said.

Most reported no side effects if they did it was nausea, headache, diaareah and that good stuff and it was very mild.

I hope the doc makes an exception for me. OH I have to be off Humira 8 weeks so February 28th I can try if they accept me into the study. They are on phase three. The first is try the drug, second phase is safety and third another report study of those it helped compared to placebo.

Posted 1/29/2013 4:58 PM (GMT 0)
Miracles,

It's frustrating that we can't get our hands on these new drugs. Budesonide has been around for a long time, so it's not like it's a big unknown safety issue.

Sounds like the study has a lot of restrictions, hopefully they can squeeze you in somehow. Is your U.C. mostly left-sided?
Posted 1/29/2013 5:53 PM (GMT 0)
Yes left sided and last scope showed some by the cecum. I called her back because in 2005 my doc said I was in remission and no sign of ulcers when I was on asacol and rowasa, but I was pooping my pants everywhere! There is something in 5 asa that make me poop urgently and make me very uptight. Like my teeth clinch so hard and I don't even know I'm doing it I get a headache. I'm have bad axiety on them, that I can't control.

However right now I'm barely on colazal right now. Not at the dose my doc wants me at. I know you have to be on 5asa to be part of the study. They won't even consider me until 2/28 when I'm 8 weeks of Humira. That drug was mean to me and I would never take it again!
Posted 1/29/2013 8:15 PM (GMT 0)
Uceris should be available soon in any case. If you can't get into the trial, hopefully you could give Uceris a shot.

The thing about the trial is you could be given placebo and just waste your time anyway. That's the thing that's always bugged me about getting into drug trials.
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