Vedolizumab MLN002 Trial Success

[oregon]

Hello everyone

I am now 10 months into the Vedolizumab trial and I am doing really well on it.

I have been flaring for 7 years and have been on prednisolone for the whole of that time (yes I know, it has been a disaster side-effect wise).

I am now almost in remission for the first time since 2003. I am off steroids!!! Which in itself is amazing for me, as I was completely steroid dependent (secondary addisons). My BMs are down from an average of 8 a day to 2 or 3. My only remaining problem is urgency in the morning, but I am told this is probably due to years of scar tissue.

So, it has been a real success for me. I was wondering how other people on the trial are doing?

Best wishes

 

[Stacyface]

Hello everyone

I am now 10 months into the Vedolizumab trial and I am doing really well on it.

I have been flaring for 7 years and have been on prednisolone for the whole of that time (yes I know, it has been a disaster side-effect wise).

I am now almost in remission for the first time since 2003. I am off steroids!!! Which in itself is amazing for me, as I was completely steroid dependent (secondary addisons). My BMs are down from an average of 8 a day to 2 or 3. My only remaining problem is urgency in the morning, but I am told this is probably due to years of scar tissue.

So, it has been a real success for me. I was wondering how other people on the trial are doing?

Best wishes

So you have been on only Prednisone in all these years? You have never tried any of the other TNF blockers? Interesting...when did this trial start? What is the makeup of this new one?...I haven't seen much on it...thanks.

 

[oregon]

Hi Stacy

I have been on imuran and asacol for the whole time too. I did try Remicade but it had no effect on me...

I believe the trial started around 1 year ago. Quite a few hospitals are doing it I think. The company is called Millenium Pharmaceuticals.

Hope this helps!

 

[Rob]

Hey oregon

I've been on the trial for about the same time as you
things have been great with it
I'm still not 100% but slowly gettin there
I was literally goin every 5-10mins a day I barely slept an so much blood it wasn't funny
i was so sore I couldn't sit or lay on my back etc
I barely made it onto the trial as they thought I wouldn't last an need surgery
well I'm now off pred was on it for about 2.5yrs at fairly high doses
an my symptoms are alot better
I'm now down to about 8bm's a day an slowly improving
hopefully I'll be on the path to gettin back to normal soon an maybe drop back on some of my other meds too

like you my worst time is the morning, that an wen I'm tryin to go to sleep
- still it's better than livin on my loo like I was lol

good luck hope things continue improving for ya

 

[My Butt Hurts]

Thanks for doing the trial, Oregon - and you too Rob.
It's nice to know that other options are out there still since I have been on most everything and Remicade will surely fail me sooner or later.
Hope you keep feeling well, congrats on getting off the pred!
MBH

 

[glum chump]

I'm really glad it worked for both of you, Oregon and Rob. I started on the study as well back in April of this year, and had three infusions, but there was no discernible difference and I was placed in the non-responsive arm of the study. However, I did get some pretty weird/scary side effects (dream-induced night terrors) and so I booted myself out of the trial.

But yeah for those for whom it works...having more options is always a good thing.

 

[tflock]

Vedolizumab is supposed to be the most specific target TNF blocker up to date for Crohns. It is being designed for Crohns so hopefully it gets FDA approved. I have only read encouraging articles on it and want it to get passed so finally there will be a drug engineered for Crohns, not made for something else and then passed onto Crohns.

 

[Mountaingem]

Congrats to you on your sucessful treatment-wishing you long-lasting relief!

 

[Rob]

Actually vedo is a spin off from another drug
initially it was used for ms sufferers but there were severe side effects from it so it was canned
but they split the drug an deleted the part That was in the drug that affected(meant to help) the brain and they concentrated on the part for the gut an came up with vedolizumab
glad they did as so far (touch wood) it seems to be workin lol
I've been able to hav most normal foods at one time or another an not pay the penelty
which is great if you hav a meal somewhere u don't hav to say "o by way waiter, I can't have................... Etc"
I jus choose somethin "easy" on the menu an seem to be ok
even had lettuce an onion an popcorn at times

so fingers crossed it keeps workin

 

[ThanksP]

How is it administered? Is it injection and how often? I'm hoping it's an improvement over the current tnf's

 

[glum chump]

Thanks for providing the clarification, Rob since Vedolizumab was initially an MS drug. And part of the reason it may not have worked for me is because I have MS as a preexisting condition, and going into the study, there was some concern that it might not work. So, in many ways, I may end up skewing the results, while many people who have Crohn's may find it quite a lifesaver.

ThanksP, it is administered by infusion. And it doesn't take as long as Remicade to dispense.

 

[Rob]

Yea it's an infussion administered drug which takes about 30mins an about 30mins of prep/paper work for the trial
so once trials are done an it's an approved drug etc I'd say you could be in an out in less than 45mins

you recieve a dose every 4weeks after your third dose
- not sure of long term tho as I'm still on the trial
but once I'm done I'll be opting for the long term trial so I'll see if the time between infussions changes

one thing from it I'm almost (an I do mean almost- not quite yet lol) over my fear of needles now from this trial
lol

I can't remember the name of the original drug that vedo evolved from, I'll have to look thru all my paper work n see if I can find it

 

[oregon]

I'm really glad it worked for both of you, Oregon and Rob. I started on the study as well back in April of this year, and had three infusions, but there was no discernible difference and I was placed in the non-responsive arm of the study. However, I did get some pretty weird/scary side effects (dream-induced night terrors) and so I booted myself out of the trial.

But yeah for those for whom it works...having more options is always a good thing.

Glum Chump - I had a REALLY scary night terror last night and I remembered you saying that you also had them when you were on the trial. Can I ask how many times it happened? Did you feel kind of like you couldnt move during the bad dream? I had a terrible night last night...

Thanks and take care

 

[glum chump]

Hi Oregon:

Yes, absolutely. I think feeling "stuck" in my dream and helpless around being able to get out of the dream was one of the scary things about these night terrors. During my initial three doses, I would get very vivid dreams that were somewhat scary during the first couple of days after getting the infusion. After my third, and more after my fourth dose, I would get the vivid dreams that were slowly escalating to much more negative and nihilistic places. The problem after my fourth infusion was that I couldn't separate my really scary dreams from reality. So even though I would wake myself up from the dream and although on one level I knew i was awake, I couldn't let go of the dream so I would be recreating the scary dream in my awake-world.

I'm not sure if I am describing this in any way that makes sense. I found it really disconcerting. The whole thing lasted a few weeks after my fourth infusion and I didn't have a fifth infusion.

 

[KOB]

Slightly different for me, UC (almost 30 years) and on high dose Pred for 15 years (yes cushings syndrome, cataracts and all the other nasties). Been on three trials (remicade, humira and something I cannot remember). Nil results. Last year very bad, spending 10-12 hours per day on the can. Looking at colon removal early next year. Surgeon says I am well over due.

Went on the Vedolizumab MLN002 Trial about three months ago. The results, given where I was at, are nothing short of amazing. Almost immediate cessation of bleeding and mucous. BMs from 20-40/day down to 6. Some urgency at times, but really a big improvement. No blood for 2 months. Surgeon is also amazed (he even used those words back to my gastroenterologist and suggested I not book surgery - call him next Feb).

Pred being reduced, hope to be off in next 2 months or so. Pretty much in remission, still feel bloated and have wind, but, as surgeon points out, the colon is pretty damaged so will take some time to get over that.

I am constantly reminded by the professionals that this may not continue, but at the moment it quacks, has feathers, a bill and webbed feet so I'm happy to call it a duck.....

Cheers,
KB

 

[oregon]

KOB - Its good to hear you are doing so well on the trial. I have been on it for over 2 years for bad UC and I am also doing great.

I hope it lasts...

Best wishes

 

[Morteza]

Hi. I'm 29 year old. I have IBD UC for 5 years. now I'm on pred 20 mg and Azathioprine 2 tab/day. But I don't have good condition. I have a question from everybody who use vedolizumab LN002. have you seen any side effects of vedolizumab? and I'm living in Iran. how can I participate in vedolizumab trial?
I will glad if anybody answer me. Thanks a lot

 

[oregon]

Hi Morteza

Sorry to hear your UC is flaring,

I have been on Vedoluzumab trial for almost 4 years now, and I am still doing good. I have not any side effects now. I had a few in the first few months - bad dreams, and night sweats. But, they have now stopped

I believe the trial is now closed, and the results are out. The drug does work, and the company is the process of obtaining a drug license.

Hopefully, you can get onto a different trial. There are usually new ones starting all the time.

Best wishes

 

[SMSIRL]

I am generally underimpressed by crohn's treatments given their blunderbuss effect on the immune system, surveillence, genome stability, with all the implications from serious infections to cancer. So, I am particularly interested in this drug given its more targeted nature (it is a monoclonal that targets a4b7 integrin). On paper it should have a much better risk-benefit profile. The picture from the tech papers is that this drug will be most effective in colonic disease.
As an aside the a4b7 integrin has a very important role in the establishment of HIV infection, so drugs like this may well have a very important role in the treatment of that disease.
Given what I know at a technical level, this is the first biological that I would "gladly" consider taking. It is the first that makes real sense.

 

[California Crohnie]

Hi Oregon:

Yes, absolutely. I think feeling "stuck" in my dream and helpless around being able to get out of the dream was one of the scary things about these night terrors. During my initial three doses, I would get very vivid dreams that were somewhat scary during the first couple of days after getting the infusion. After my third, and more after my fourth dose, I would get the vivid dreams that were slowly escalating to much more negative and nihilistic places. The problem after my fourth infusion was that I couldn't separate my really scary dreams from reality. So even though I would wake myself up from the dream and although on one level I knew i was awake, I couldn't let go of the dream so I would be recreating the scary dream in my awake-world.

I'm not sure if I am describing this in any way that makes sense. I found it really disconcerting. The whole thing lasted a few weeks after my fourth infusion and I didn't have a fifth infusion.

Found this forum after searching for anything related to Vedo and bad dreams. I too, can relate to both Oregon and Glum Chump! This morning I had my 3rd dose of Vedolizumab. Several hours after the infusion I found myself getting very tired so I took a nap (could be the medication or just the early infusion). In the dream I was paralyzed and extremely confused. I remember trying to let my parents know something was wrong but I just couldn't. I was stuck and couldn't wake up out of it. I feel asleep on the couch and the dream took place in the same exact spot. When I woke up it was very hard to convince myself that it wasn't real. It was all so clear and I was so frozen trying to get out/wake up for such a long time. I even remember trying to scream multiple times for help at one point and I couldn't. This same thing happened in my bed about a month ago(after my last infusion). The setting of where you're "stuck" is the same place you are sleeping so it feels like thats how you woke up. Very scary and very real feeling. I almost wake up wondering if I was ever dreaming or hallucinating because your surroundings and (for me my parents mannerisms) are so on point. I'm not one to ever have nightmares so this is all very new for me.

 

[KOB]

Given what I know at a technical level, this is the first biological that I would "gladly" consider taking. It is the first that makes real sense.

And it may indeed work. For me, see my earlier post, it just stopped working almost 12 months to the day it started working. I must say, other than the monthly infusion which took a couple of hours or so, I had absolutely no side effects and when it was working it was great, complete remission.

After that tried tacrolimus cream to no avail, then there was nowhere to go, no meds left to try etc etc. So Large Intestine removed about 4 weeks ago. It is what it is. I had the JPouch done so hopefully reversal in a few months, but, at best, committed to a life of (predictable) diarrhea.

I note with most of the 'biologicals' and, I suppose, most other treatments, they never seem to last. There doesn't seem to be a solution for UC and/or crohn's that stands the test of time other than surgery.

Cheers
kevin

 

[oregon]

California Chronie - Your nightmares sound exactly like mine did. I was stuck and paralysed too. But, they do eventually stop. I have been on the drug for around 4 years now and I have not had any nightmares for over 3 years.

KOB - I am sorry to hear that the Vedo stopped working for you. I am still in remission and the vedo is, thankfully, still working for me. I had my latest infusion a couple of days ago. I get so scared of reading stories like yours that it might stop working. I hope that doesn't happen to me.

Good luck with your take down. Keep us informed

Best wishes

 

[Patrice]

Oregon if you don't mind me asking do you have crohns or UC? I have crohns & have had 2 infusions & have not seen any improvement. When did you see the pain start to decrease & start to feel better. Thank you

 

[oregon]

Patrice - I have UC. It took around 6 months for me to start to see any major improvement. It was slow progress but the remission has been amazing. Definately worth hanging in there.

My friend who has vedo infusions at the same time as me at my hospital every month has Crohns and she has also been in remission for 3 years now and doing extremely well. Like me, she also had to wait several months before seeing any improvement

Best wishes

 

[Patrice]

Oregon, thank you so much for your reply. I have been waiting with no results & I am on TPN . I felt relieved after seeing your post. I am very happy you & your friend have had good results.

 

[Crohn2357]

oregon, may I ask you, do you use vedolizumab as a monotherapy or do you use it with an immunosuppressant(like 6mp, imuran, mtx)?