Vedolizumab Trial

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njprrogers

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Hey Everyone,

I just started the Vedolizumab trial yesterday.

I got my first infusion and other than losing a bit of sleep last night I haven't noticed too much in the way of side effects.

I'll keep you up to date with my progression on this thread. I know we all want to hear some good news. Also, if you're on Vedo, I'd love to hear how you're doing.

Thanks,

Nick
 
Hi Nick

just read ya post an noticed pretty much same as myself,
my crohns has affected me in same area as yourself

I'm sittin in hospital right as we speak attempting too sort it out

I've been trying immuran 200mg a day , mesalazine (salafalk) 1500 mg orally an 4g enima a day , and 50 mg predniscone daily along with multi vitamins etc etc. Also was on remicade trial but that proved fruitless ( infact I'd feel worse than ever for about 4-5 days after the infussion so we stopped that

so now in here at hospital they've stopped my predniscone an put my on hydraquaterzone ( how ever it spelt) injections 4 times a day an anti biotic and a blood thinning injection too avoid clotting
slowly slowly I've been getting better (been here a week now) but can't stay on these meds as gotta stay on hospital too recieve them

so my specialist has done all the tests an given me the choice
surgery with a bag, usteki drug trial , or this one mln0002

decission time in bout 8hrs

so at this point. I'm looking at joining you on the trial
love too hear how you goin along with it over next few days/ weeks etc

Rob
 
I googled it sue
plus my drs gave me some paper work too read
I'll try typin some info up in a min once they put the room lights on
 
Hey Rob,

Sounds like you're not in a great place at the moment. I really hope you feel well soon.

The Vedo is definitely worth trying but it might take a couple of weeks to get on it.

As ever with these things, it is very difficult to work out how successful it has been up to now. Hopefully, we might get some anecdotal evidence support of it here on this forum.

I hope you feel better soon... Good Luck!

Nick
 
Cheers mate

be good too hear some information about this drug

hope it works for you
 
Vedo Update - two weeks in!

Hi,

Just thought I'd give you an update on how I am feeling on the Vedolimuzab.

I got my first infusion 13 days ago - I am in again tomorrow for no. 2.

I had no allergic reactions to the initial infusion.

For the first week I was pretty exhausted. I also started to get what I would think of as constipated. The second week I am feeling much brighter... there was definitely major changes going on in my body that first week.

So, now for the good news. I think this stuff might be working. In the ten days up to the infusion I had 3 days of 18-20 bm's. The worst day so far on vedo was a week ago with 5 bm's. (I'm having to count for the trial. I'm not that obsessed!)

I have felt pretty constipated throughout - and as a result have had a lot of mouth ulcers - so I haven't always felt great but this is gonna take a while. And I think that that is a positive start.

I'm really looking forward to seeing how I get on in the next couple of weeks. I'll be in better condition going in tomorrow for my second infusion so we'll see!

Nick
 
That is HUGE! From 18 BMs down to 5?? That's a good sign!
Thank you from all of us for doing a trial. We all may need it in the future.
Hope you feel better and better each day!
 
That's *incredible* Nick! Sounds very promising. Can you talk to your doc and get something for the mouth ulcers? I know those can be no fun. Thanks for the update - keep 'em coming!!
 
Hey everyone,

Just going to temper the optimism of my last post a little bit. I've had a couple of bad days in between ... 20 bm's followed by 10 bm's.

Not great really but I had been feeling constipated and I suppose it had to break some time. The only positive is I hate that constipated feeling ... I instantly get lots of mouth ulcers and go off my food. I'm now back on my food and the mouth ulcers have receded a bit.

As for the Vedo... I'm now feeling a little bit more pessimistic for obvious reasons. I'll just have to see how I bear up over the weekend.

It's never plain sailing, is it?

Nick
 
Hey Nick thanks for the update

I'm seein the trial nurse this week about starting this myself
so hopefully 2-3 weeks time I'll be testing it out
readin ya signiture i see ur crohns is pretty much same as where mine is

I'm hopin this drug will work for me as my specialist says there's not many more options left apart from surgery
 
Hey Rob,

Fingers crossed the you get on the Vedo and it works for you. I've tried Humira which had no effect really whereas Vedo has been up and down but it has definitely had an effect. I just have to wait and see.

Have you tried any foam pred enemas (Predfoam here in Ireland) considering the location of your disease? They worked for me over a 3 year period but I had 5 out of 7 years on steroids which I now have to get off. Hence the vedo trial.

Fingers crossed anyway!

Nick
 
I tried mesalazine enimas but they didn't provide much relief
the best thing I found was when in hospital I recieved hydrocortisone injections
which stablised my cd an helped repair some damage, enuff too make life bit more bareable an stopped most of the bleeding

I've been on and off pred for the last 4 yrs for occasional flare ups but I've been on it now for the past 6 months with my current - worst flare

I tried remicade myself but didn't do anything infact I felt worse after my infussions so I stopped after the third one

with the vedolizumab I'll be on an open label trial so I know I'll get the drug for atleast the first 6-8 weeks after that it will go into a placebo trial where I may get it or I may not
stil 6 weeks od getting it is better than none
so fingers crossed the trial nurse agrees it's a good idea
 
Sorry to hear the Vedo is rocky for you Nick - I hope you will start getting more relief buddy!

Rob- good luck! It will be interesting to see how the open label part goes for you!
 
Hey there,

Just thought I would give you an update after my flare last week.

I was pretty constipated when I started the Vedo and then spectacularly not! 35 trips to the toilet over a 36 hour period.

I have definitely levelled out now and I'm feeling generally well. The drug is definitely having an effect. I've decided to take lactulose when I feel constipation coming on to avoid last week's flare.

It feels weird taking a laxative with Crohn's but hey, whatever gets you through.

Hope you're doing well, Rob - I took those mesalazine enemas lots over the years - I found them very limited. Whereas the Predfoam enemas gave me a lot of relief... and the good thing about them is that they are not nearly as harmful as taking steroids orally. Might be worth asking about but I suspect your doctor would have suggested them if they were appropriate. A little bit more positive on the Vedo this time so I hope you get on. I'm at the same trial stage as you, the first two shots were open label followed by being randomized into a placebo and two possible doses.

Cheers,

Nick
 
Good news for you!!! I keep lurking around to see how you are doing. I am glad you are welll. It is always good to hear some good news...Sue
 
Well got my first meetin with trial nurse in about 4?hours
can't wait
got some blood tests, ECG an possibly somethin else

hopin goes well
 
Hey everyone, just letting you know I started the trial yesterday and got my first dose. Everything went well but I felt a little tired afterward...although, i did forget my pred yesterday morning so that may be why too. I'm not feeling a difference yet as far as my inflammation and i'm sure its too early but I have had a ton of energy today which has been my biggest battle. I've got another infusion March 10th. Thanks to everyone on this forum for providing a place for us Crohnies to come and talk about the three biggest things in a Chronies life....Medication, Food, and Poo :p

I'll keep you guys up to date :D
 
Good luck with the trial an keep us posted

I've started my phone diary but hav a week b4 I can get my first infusion
done my blood tests, ECG, chest exray and pysical
jus waitin on he blood test results

so fingers crossed I'll be able to report back here with news soon
 
ThatGuy2006 said:
Everything went well but I felt a little tired afterward...although, i did forget my pred yesterday morning so that may be why too.

I'll keep you guys up to date :D
Click to expand...

Hey there... I felt tired as well after both doses so I think it maybe a reaction of some sort. There's gonna be something happening anyway!

I'm 2 weeks into my second dose. I feel o.k... A little bit constipated again which I don't enjoy because it always ends badly! I still think I am getting some relief but the drug is not a 'silver bullet' for me.

That said, I am off the Predfoam for the first time in 3 years and keeping it together so maybe I should get some perspective!
 
Well I had my first dose of vedolizumab yesterday :)
still early days yet but hopefully it goes well

I did get my first decent nights (unbroken) sleep for ages :) 8hrs worth

keep you all posted
 
Fingers crossed for you Rob...so do you feel like a guinea pig??? I too didnt do well on the other Biologics, so hopefully this one will be THE one. Just hope by the time it gets approved by the FDA here in Canada I wont be too bad off. Glad you finally got some sleep. No one has no idea how much sleep is needed to heal... keep going. Hope you get relief soon!
 
Thanks Pen
hopefully you can find something that works for you soon

yea sleep is very important with this disease and unfortunatly it's something we seem too lack

lol i do feel a bit like a guinee pig, but at same time I'm excited lol
 
Hello everyone

I was wondering how everyone on the trial is doing?

I will be having my 4th infusion on 22 March. I have noticed some improvement, my last scope showed mild inflammation (it was moderate at week 0).

So, not in remission but it does look better.

Take care
 
Rob: Welcome to the gang! Fantastic to hear that you got on board. I really hope it works out for you.

Personally, I am doing well at the moment. Going for my third infusion next wednesday - it could be one of three : my current dose, a lower dose or a placebo.

I'm off the 'roids for the first time in 3 years and I'm now stable. I had a very good week last week and a little flare this week. It wasn't too dramatic and I'm feeling a little better than I was Monday.

All in all, I'm pretty upbeat at the moment about the way it is going.

Oregon - sounds like you're getting similar benefits. It's a slow mover I think. We just have to hang on in. It'd be lovely if after 6 months the trend of improvement continued!
 
Hey Guys,

Just to give you an update on my personal experience with Vedolimuzab.

I felt good for a couple of weeks after my second dose. However, I had a flare then and kinda felt like the drug was wearing off then for the ensuing 10 days.

I got registered as a non-responder with the trial as a result. What that means is that the placebo and lower dosage were eliminated for me and I remain on Vedolimuzab on a monthly basis.

I felt fairly crapola for the last ten days before getting the drug again, I must say. I got it again last Wednesday and I am back to feeling good again now.

I just hope that I get longer than the approx 18 days well being this time.

Thanks!
 
I hope that things improve for ya Nick

I'm headin in for my second dose today, things seemed a little betta after my first dose, but not sure if that was jus a coincidence or not?

Guess time an more doses will tell
 
theend2 said:
Nick what was the average prednisone dose you were on during that 5 to 7 years of being on it?
Click to expand...

I was on 40mg orally for several months and then a maintenace of 10mg for about 2 years.

I took predfoam then for three years - which are 20mg enemas.

Why do you ask?

And Rob - hope it goes well for you. I am definitely improved again after my third dose. I just don't know for how long!
 
Hey Guys, thanks for keeping us posted. I am always lurking :) I am hoping this is the med...For most of us...I am hoping there is something that will have a higher success rate than what they've got out there...And you guys are it... :) Sue
 
I was just wondering because I am also on long term prednisone use. I have been on 40 to 60 mg for the past 2 and 1/2 years or so. Just wondering 5 to 7 years is a long time to be on 40mg so I was just wondering so I see it was around 10 mg for most of that 5 to 7 years. Thanks.
 
Well had my second dose yesterday and so far so good.
Once again I felt fairly tired a few hours later and slept pretty well. (not a bad side effect lol)
glad that ya feelin better again Nick, hope it lasts this time

I've got four weeks now til my next dose so I'll see how long it lasts

I've noticed a lesser amount of bm a day(12-19) still high but far less than my 30-40 times a day, and not as urgent either instead of a 5-10 sec warning sometimes I get a min or two
also less blood, and a firming of my stools
I don't hav the constant stomache cramps either- I stil get some but it's not 24/7 like b4 so I guess they more noticable now wen I do get them if that makes sense
I'm still on my normal meds, and will be for a while, they want too wait for the drug to fully kick in then ween me off the meds if possible

how often do you get your dose Nick? Mine is every four weeks now.
But if I show a huge improvement by dose 3 I could gobon placebo:( but from what trial nurse has said my improvements aren't enough as my bm are stil too high, so hopefully I keep gettin it as I can def say I've noticed a change
plus she said most people notice the biggest change after the 4-5th dose, so fingers crossed

keep ya all posted
 
Hey Rob,

I'm on every 4 weeks as well. Because I got registered as a fail, there was no placebo for me. I reckon you might be the same... I think if they see a full recovery they want to prove that that recovery was from the drug. Hence the placebo.

Interesting what you say about the 4th or 5th dose seeing the biggest improvement. I am the first to try it in Beaumont Hospital here in Dublin so I aint getting the benefit of any experience... and even so, I think they are reluctant to say anything because of the 'blind' nature of the trial.

Still feeling o.k. now. BM's are definitely down. Just hope it lasts through the four weeks. I was talking to the Gastro today and he said the next step would probably be surgery to give the bowel some rest. I sincerely hope not!

I hope it goes well for you, Rob!
 
Hope things improve for you Nick

my trial nurse said it's fine to use lomotil or imodium too aslong as she knows about it

I found by having two tablets in the morning calms me quite a bit drasticky reducing the number of bm's
also if I do this 3 days in a row then stop the 4th day is same an 5th day starts ramping back up
this is something she said was noticed in some uc cases too
maybe u can ask about using it

don't need heaps of it and it may jus be enough to slow things up enough for the drug to Do it's work
also are you still on any othr drugs?
I'm stil on all mine ATM they won't taper me off til they see vast improvement
but they believe that with my current meds and this new drug that I should get the best benifet
but I only just scrapped into this trial as originally they thought I may be to bad to go on it an need surgery instead
as you need a score around 240 I think and mine was over 500
so they said I may take longer to recover etc as alot to repair/fix etc
could be the same for you perhaps

I know the feeling about wanting to avoid surgery, I had a meeting with a surgeon yesterday about keeping my options open incase this doesn't work, an the news wasn't as good as I'd hoped
originally i was lookin at a colonoscopy if I was to hav surgery, bit now they say I'd hav to hav an illosomy instead as my large bowel and colon and rectum is that bad that they would need to remove the lot

even the surgeon said he hopes that this drug starts working an does it's job

best of luck to you nick and hope things are on the up n up
I'm hopin this drug is just what I need, stil early days for me but it looks promissing so far :)
 
Is this drug Vedolizumab MLN0002 being test specifically for Ulcerative Colitis or Just for Crohns or for both? Reason I ask is because seems that Cimzia is only been tested for Crohns and only approved based on those crohns tests this is why I was denied insurance coverage on getting this drug.
 
Hi the end

from what I've read and have been told this drug was originally tested on uc, and after showing good results it was trialled on cd and has started showing results too

it's still in early days of testing tho

it's not available to the public as such ATM as it's only in trial stage ATM
so ud hav to qualify to meet there requirements etc before getting onto the trial, but once you do the drug is free, which is handy as I heard it's something like $10grand a dose (ouch)
 
Cheers Rob!

I think you're in a lot worse place than me at the moment. I had severe symptoms up to 24 months ago including fistulae but the steroids brought that back to moderate. Just gotta get off the steroids!

Hang in there, buddy. I'm sure that you'll get some relief from Vedo!
 
Hello everyone

Just thought i'd write a quick update on my experience on the trial (I have UC).

I had my 4th infusion this week, and things are going pretty well. I am down from 5 BMs to 2 BMs, with no bleeding. Which I am thrilled about. But - I still have major urgency issues. Got a BAD cold this week even though im super careful about avoiding places where I may pick one up from.

I also have the fatigue after the infusion, but not too bad. Im still the only one enrolled in the trial at my hospital (London).

Take care
 
Fatigue?
As in you feel really tired after you hav the infusion or all the time?

After both my infussions (approx 5-6hrs) I felt really really buggered an slept like a log and the day after was lathargic

my second infusion- just on tues same again except wed I wasn't to bad, but today - thurs I was stuffed, I got up had a shower then went back to bed an slept another 6hrs the rest of day I was flat and now on strugglin keep my eyes open so off to bed early for me

see how I go tomorrow
 
Hey Guys,

I've stopped my involvement with the Vedo trial. I had started to get worse and decided that I would take some Predfoam which took me out of the study.

In general I think I did get some relief initially from the drug but that after 3 infusions it was working for less time. And I was completely knackered when it did stop working with a big flare up of mouth ulcers.

I know that this drug will work for some - just like Humira and Infliximab which I have failed with - and not for others. I just wish everyone the best who tries it.

Nick
 
Hey Nj, so the trials could mean you are on it for sure or a placebo? I too failed at Remicade and Humira, and Cimzia isnt available here yet. My Gi isn't keen on putting me on Cimzia because he feels the biologics don't work for me, and may not. Frustrating when some are doing so well and others.... I am on Methotrexate and there is some improvement but still need a few more shots to really see if it will work this time around.

So what is up for YOU now?
 
Nick - Sorry to hear that the trial didnt work out for you. I hope something else comes along soon.

Best wishes
 
Just thought I'd bump this thread back up an give an update

I've now had 4 doses of this and continuing to improve
it's not like a sprint race but more like a marathon, if ya get my meaning

I stil hav my up an down days tho the down days aren't as frequent or as bad as before
I think the bad days could be due to me.... seems if in bad or lazy an eat somethin I know I shouldn't that I hav a bad fy the following day

but this also helps in a way cos if I hav something I shouldn't i put it in my trial diary I'm keeping and then I can see what happens etc
if I notice a bad day I don't eat it again or wait an level out an try again to see if was jus a coincidence or not

I've found that possibly garlic bread is one of these foods, which sux as I love it

on my last visit to the hospital for my dose they did a Blood test to see if I could begin to taper my pred
but I failed that as I've improved but not enough yet that I can start to taper
so guess it's gonna be a long journey an I'll jus hav to be patient

bm's are down and no longer as um loose as before an becoming more formed tmi I know sorry
I still get some pains n cramps but nowhere near as bad or regularly as before
an up until other day I'd been blood free for weeks
I'm putting the blood returning down to something I'd eaten - I hope
seems to hav gone again so we will see

also it's not as sore or tender down there now either an I can actually sit down on something that doesn't hav 2 feet of cushion on it lol
so I guess that means it's doin somethin as thts where my biggest prob was

so fingers crossed it keeps headin in this direction and after a few more doses il be well on the road to remission
 
Great news Rob!! I was wondering how you were doing with the trial. I hope you continue to improve :)
 
Hey Rob, glad it is working for ya! I too am in the same boat having good days and bad, and the though of remission is what keeps me positive. Just had my 11th shot of Metho and still having flares. I envy those whose can eat anything and go anywhere at anytime. I am getting there, hope a full remission is in for both of us!
 
Hello:

I've only recently joined this forum and saw this thread so thought I'd add my two cents!

I also started this study and have received three infusions. At my last infusion, I was placed in the "non-respondent" category as there was no detectable difference in my health status (12-15 bm's a day).

I'm strongly considering withdrawing from the study although I feel I should stick it out for at least one more, given some people have noticed an improvement after their fourth and fifth infusion. However, I've been getting incredibly vivid dreams, all of which are fairly negative/nihilistic. The dreams are really "active" and cause anxiety when I wake from them. I also am having a hard time controlling my thoughts and finding it kind of scary.

I haven't noticed that anyone else has these side effects from the Crohn's trials, but the nurse felt that the side effects I'm experiencing might be due to the fact that I also have MS.

Anyways, just thought I'd share my experience...and I'm pretty sure I'll not go for my next infusion which is scheduled for June 18th.
 
Sorry to hear that glum, hope everything calms down an works out for you

being a trial they don't know the full out come of what the drug will do with people etc which is why they need volunteers such as yourself an me etc to trial the drugs an see what happens
unfortunatly not all drugs are going to agree with all people, bit like how some ppl are allergic to penacilan etc

hopefully if you pull out from the trial your problems stop

good luck
 
Hi Rob:

Thanks for your kind words/encouragement. I'm really glad to hear the drug is working for you. I had been hopeful that the drug would work---when I first started, the nurse had mentioned that the one other person taking it was feeling really good, and I had plans/dreams to also be a poster child for these meds (especially given the price of the drug when it came on the market, as you mentioned earlier!).

If it weren't for the fact that I can't seem to control these nihilistic thoughts/ideations, I would continue with the drugs. At this point, I'm more scared of myself and where these thoughts will lead me in the middle of the night, so I think I will give it a miss.

I wish you the very best success with this drug!
 
glum chump said:
Hello:

I've only recently joined this forum and saw this thread so thought I'd add my two cents!

I also started this study and have received three infusions. At my last infusion, I was placed in the "non-respondent" category as there was no detectable difference in my health status (12-15 bm's a day).

I'm strongly considering withdrawing from the study although I feel I should stick it out for at least one more, given some people have noticed an improvement after their fourth and fifth infusion. However, I've been getting incredibly vivid dreams, all of which are fairly negative/nihilistic. The dreams are really "active" and cause anxiety when I wake from them. I also am having a hard time controlling my thoughts and finding it kind of scary.

I haven't noticed that anyone else has these side effects from the Crohn's trials, but the nurse felt that the side effects I'm experiencing might be due to the fact that I also have MS.

Anyways, just thought I'd share my experience...and I'm pretty sure I'll not go for my next infusion which is scheduled for June 18th.
Click to expand...

Hi glum_chump, I am also in the trial and having the same problems with you as far as very intense/vivid dreams and irrational thoughts. I have told the person running my trial of these problems but so far no one has really helped or thought for these to be associated with the drug although they started after I started the trial (in december). It makes me feel so much better to see that someone else has had these side effects since I was beginning to think I was going crazy, I was considering withdrawl but I thought the issues may just be related to me so I didn't want to. Now that you have also brought up this issue I may consider withdrawing because like you, its getting scary and these thoughts are starting to affect my quality of life.
 
Hi Crohns gleek:

I'm really sorry to hear that you've have these same effects, and at the same time, like you, I'm relieved that there's another person who has experienced the same kinds of issues.

I told the folks at the research centre about the issues I was facing (I sent them an email detailing the effects rather than talking to them so that there would be some kind of written paper trail...having been on several drug trials, I find that study folks are much quicker to either minimize or dismiss my verbal feedback).

The nurse and the research GI met with me and felt that, given the timing of these effects, it would most likely be caused by the drug and agreed I should come off of them. I was to get my next infusion today. I was told that they would be writing this up as a "Significant Event" and send it through to the study monitors.

Yes, these symptoms were quite scary and at first, I thought I was going crazy. And then I realized that if I don't stop these drugs, I might actually get diagnosed with some form of mental illness (just based on the symptoms). And I really don't need yet another diagnosis!

If you'd like me to send the note I sent to the researcher's, I can send it to you off-forum, or if you'd like to chat more, then I'm happy to do that as well. And you're welcome to use me as an example---my research study people kept saying, "We've had no other reports of anyone else experiencing these symptoms."

Cheers
 
Hey guys sorry to hear that you've had such bad luck with the trial
hope things improve for yas soon

I've just had my 5th infussion this week and things are goin well for me so far
it's a slow proccess but I'm happy if it keeps improving

yea still hav up n down days but nowhere near as many down days as I used to
so I'm crossin my fingers an hopin every infussion is a step closer to a normal life again like b4 my current flare
 
Hey Rob:

I will cross my fingers for you as well! I'm so happy to hear that the trial is offering you some relief and some cause for excitement/anticipation.

From what I've heard about others' experience, it does seem that Vedolizumab works itself gradually...here's looking at more 'up' days for you.
 
Rash on face?

New to forum......Very glad to find you all....
I have been a part of the study trial now for awhile, in Seattle Wa., and have developed a rash on my face....
Wondered if anyone else has experienced this ???
On healingwell.com forum I read where one gal had to quit study because of rash on face, diagnosed as Rosacea, caused by the drug.....

Jeff
 
Welcome Jaj :D. Glad you found us here. I hope that you would join us by telling us your journey on a YOUR STORY thread. Rashes are very common with Crohns and UC. Please introduce yourself so we can all welcome you and learn from you too. :)
 

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