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Vedolizumab

So I was browsing around the internet today, and I noticed that a new drug called vedolizumab is entering phase III clinical trials. This drug isn't a new anti-TNF, which I suppose is a good thing, as we already have at least three of those on the market, and we need to break some new ground. Instead, it's more of an improved version of Tysabri. Supposedly, since vedolizumab targets the alpha4beta7 integrin rather than just the alpha4 integrin like Tysabri, it can "modulate inflammation specifically in the GI tract without systemic immunosuppression", thus making it able to "confer efficacy in IBD with an improved safety profile and risk-to-benefit ratio".

Science babble here. Hopefully it'll be as good of a drug as the article makes out, and work for people that anti-TNFa's were ineffective for, minus risk factors like Tysabri's PML. And so long as it survives its phase III trials it could be on the market soon, I'd think. Keep your eyes peeled. :)
 
Thanks, Procycon, for posting this. I have never heard of it before. We definitely need some new treatments for Crohn's!! My doctor wants me to try Tysabri, but I am so scared of the PML possible side effect. Hopefully vedolizumab will pass the tests and be available soon.
 
Almost in remission myself, but I'm excited about this prospect, as I've liquidated just about all other options except for Tysabri and a colectomy....I don't want surgery if I can avoid it, and I wouldn't trust Tysabri with my life (oh wait, that's why I won't take it! Because nobody seems capable of preventing/understanding PML!)

Hopefully I'll never need to consider another solution, but statistically, flareups just seem to happen. :confused2:

What'd really be nice is a cure being in phase III. :)
 
Today was my first day of clinical study for Vedolizumab aka MLN0002. I had the infusion at 1:00 stayed for the 2 hour observation and I'm home searching the net as much as I did before the trial!
 
shmooda said:
Today was my first day of clinical study for Vedolizumab aka MLN0002. I had the infusion at 1:00 stayed for the 2 hour observation and I'm home searching the net as much as I did before the trial!
I am interested in hearing about how things are progressing with the Vedolizumab...
 
Hey there kjeanb and :welcome:. Unfortunately we haven't heard from Shmooda in quite a while. Just didn't want you to think no one was responding to you. Take a peek around the forum - if you have any other questions - let us know!
 
I start the trial tomorrow. I'll let you know how it goes. Might be the drug, might be placebo. Fingers crossed for the drug, and toes crossed that it works!
 
well, i had infusion number 1 today. It went well- no reactions, no nothing really. If I were a betting girl, I think it's placebo for me... but the good news is I am on the double blind part of the trial for only 6 weeks then they move me to the drug for certain. I'll keep you all posted. So glad to have found this site to share and learn... thanks!
 
Hello everyone

I have been on the trial for 18 months, so I thought I would post my story.

I have tried every drug out there and nothing has ever worked for me. Not Imuran, Remicade, all the 5asa, Tacrolimus, etc... I was on pred for 8 years straight! Totally steroid-dependent. A lot of that time, I was on pretty high doses.

This was a last resort for me. And it has been a miracle.

I had my first infusion in January 2010, and within 3 months, I saw an improvement. Bleeding stopped, and the number of BMs went down from 7 to 3.

I came off steroids for the first time in November 2010 and everything has been fine (was a super slow taper over a long time, as I had developed secondary addisons disease due to long term pred use). My adrenals have finally started working again..

There are 2 other patients in the study at my hospital in the UK, and they are also doing good. However, I know of a few people who did not respond, and they left the trial.

It has been a life saver for me, and I really hope it gets approved. I was double blinded for the first 12 months, so in theory, I could have gotten placebo, but I know I didnt as I got a few side-effects, nothing major though.

Im on open label now for 2 years now (6 months in).

I have 2 BMs a day, with no bleeding, or pain. Can eat most things. Still have some urgency in the morning, but I can live with that.

Hope this is useful. Happy to help with any queries.

Take care
 
That's great news. Hopefully it improves to getting you into 100% remission.
I have UC and am 3 days into 6-MP. After many years on asacol, it stopped working and the Dr put me on the pred. That works but after trailing off, I seem to get back on. I hope to see newer drugs that are more targeted such as this pop up! Good luck to all taking it and please keep us posted.
 
I've been in a vedolizumab study since Dec. 2009 after failing every other med available. My story is like oregon's above in that I was steroid-dependent for years. I'm hoping to find more people who are in a vedo trial to share our stories.

My experience with vedo so far...

I did not respond initially and was moved into an open-label study after two months. I receive infusions every 3-4 weeks. After each infusion, I am very tired for the next two or days. Nausea begins about 24 hours after the infusion and has lasted as long as a week. I would level out for about two weeks between infusions with reduced BMs and a better appetite then start feeling bad again pretty quickly before the next infusion. This pattern lasted for about a year. Now, for the past five or six months, I just feel like hell all the time. I'm losing weight again. I feel anorexic because I look at food as the enemy. It hurts so much to eat and it's the most frustrating experience that only people with IBD can really understand. I'm passing blood again. When I do eat, I go to the bathroom 10 or more times a day and sometimes two or three times at night--when I make it out of bed in time.

I was so hopeful the vedolizumab would put me into remission. I've never experienced remission and assume it means fewer than four BMs per day, no pain, no bleeding, and the ability to eat without pain and nausea.

Having said all of that, I'm not dropping out of the study yet. I haven't hit that place where I think I need to go to the hospital. I have to attribute it to the vedo. I'm in my longest hospital-free run since being diagnosed more than 15 years ago. The side effects from vedo are nothing compared to the damage caused by true immunosuppresants and immunomodulators. With vedo, there's only been the fatigue, nausea, and migraine headaches. If I leave the study, it's back to pred, and I'm not ready for it.

So there's my vedolizumab story. I'm looking forward to hearing from others.
 
Lynne - I am so sorry to hear your story.

I am still on the Vedo trial, and I am still in remission (aside from some morning urgency). But, I really get worried when I read stories such as yours. I have to say, two other patients on the trial ay my hospital have dropped out as they also stopped responding to the drug.

What are the DR's suggesting you do? Which other meds are you on? I don't blame you for not wanting to go back to pred. I dread ever having to go back on it.

Can you try enrolling on a different trial? I don't know what else to suggest.

There are two other patients on the vedo trial at my hospital who are also in remission after long flares in the past. I am constantly asking the GIs how they are getting on. And they seem to be doing good right now....

I really hope you get better soon. Keep us informed of any developments..

Take care
 
Hi all. I have been on the Vedolizumab Trial for over 2 years now and I see a world of change. I have been in remission for over 1 1/2 years now. Went from having 16 bms a day down to 2!!!! Pain rears it's ugly head once in a while, but it's usually my fault for overeating or eating foods that I know I can't tolerate. The drug is going to be up for FDA approval this spring. I recently signed on for another 3 years!
 
Wow... this is very encouraging. Thanks for the update smooda!! So no serious side effects? Does anybody know how long it will take to hit the market after the approval?


Hi all. I have been on the Vedolizumab Trial for over 2 years now and I see a world of change. I have been in remission for over 1 1/2 years now. Went from having 16 bms a day down to 2!!!! Pain rears it's ugly head once in a while, but it's usually my fault for overeating or eating foods that I know I can't tolerate. The drug is going to be up for FDA approval this spring. I recently signed on for another 3 years!
 
I start Vedo on the 6th. Study is now in phase 4. Have been on 4000mg sulfasalizine, 30mg prednisone, 100mg 6-MP for 4 years, with no progress. Have been hospitalized 7 times and received over 10 units of blood. The prednisone has made me insulin dependant. Had very, very bad reaction to Remicade. Am so very much looking forward to trying something that finally works. Will post my progress as each appointment happens.
 
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