New interim phase 3 maintenance data support the long-term efficacy of vedolizumab

Takeda Pharmaceuticals International GmbH ("Takeda") have announced that new data from GEMINI LTS (Long-Term Safety), a Phase 3, ongoing, open-label extension study of Entyvio® (vedolizumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) will be presented as oral presentations during the 21st United European Gastroenterology Week (UEGW) in Vienna, Austria.

Two of the abstracts demonstrate that the efficacy observed in vedolizumab Phase 3 induction and maintenance trials of 52 weeks was maintained over the course of an additional 52 weeks of open label follow up.

Patients who completed or withdrew early from the double-blind, randomized, placebo-controlled maintenance studies GEMINI 1 and 2 were eligible to enrol in GEMINI LTS. Patients included in the Efficacy Population (GEMINI completers) received vedolizumab 300 mg IV doses every four weeks (Q4W).* Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS, 66 percent were in clinical remission at week 52 and 73 percent were in clinical remission at week 104. In addition, 79 percent had clinical response at week 52 and 80 percent had clinical response at week 104.

Of the CD patients who completed GEMINI 2 and enrolled in GEMINI LTS, 57 percent were in clinical remission at week 52 and 61 percent were in clinical remission at week 104. In addition, 81 percent had clinical response at week 52 and 74 percent had clinical response at week 104. Although open-label, these data add to the evidence bank of vedolizumab, supporting the positive findings of the pivotal Phase 3 GEMINI 1 and 2 studies, which assessed the efficacy and safety of adult patients with moderately to severely active UC and CD, respectively, over 52 weeks.

"Ulcerative colitis and Crohn's disease are chronic diseases that can have a serious impact on patients. As physicians, our aim is to help patients achieve and maintain disease remission," said Prof. Dr. Severine Vermeire, University Hospitals Leuven, Belgium. "Current findings from the long-term extension study add to the evidence bank of vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn's disease."

Vedolizumab is a gut-selective humanized monoclonal antibody that has recently been made available in the United States and the European Union, and has also received approval in Australia, under the trade name Entyvio® (vedolizumab). It is the first and only biologic therapy to be approved in the European Union simultaneously for the treatment of adults with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha antagonist.

http://www.medicalnewstoday.com/releases/283466.php

Someone wake me when the endpoint is mucosal healing instead of clinical remission. Or that data is at least presented.

So sick of news sites and people being paid by that company promoting this. Vedoluzimab DOES NOT work for crohn's disease. It's on it's 4th failed trial.

"Vedolizumab was not more effective than placebo"

http://www.ncbi.nlm.nih.gov/pubmed/24859203

From may 2014.

This is AFTER GI from hospitals saying they would veto it because it was not effective in trials for CD.

http://www.ncbi.nlm.nih.gov/pubmed/?term=veto+vedoluzimab

kiny said:

So sick of news sites and people being paid by that company promoting this. Vedoluzimab DOES NOT work for crohn's disease. It's on it's 4th failed trial.

"Vedolizumab was not more effective than placebo"

http://www.ncbi.nlm.nih.gov/pubmed/24859203

Click to expand...

CONCLUSIONS:

Vedolizumab was not more effective than placebo in inducing clinical remission at week 6 among patients with CD in whom previous treatment with TNF antagonists had failed. The therapeutic benefits of vedolizumab in these patients were detectable at week 10. ClinicalTrials.gov number: NCT01224171.

Click to expand...

At week 6, yes. But it appears at week 10 clinical remission rates were higher than placebo.

With that said, I'm still not all that excited about Vedolizumab.

http://www.ncbi.nlm.nih.gov/pubmed/23964933

14% remission rate, 7% placebo. That's lower than studies for pentasa.

15.2% of those given vedolizumab and 12.1% of those given placebo were in remission at week 6.

3% higher reimission rate than placebo, Vedoluzimab DOES NOT work for crohn's disease, in the hospital I go to, doctors said they refuse to trial.

It has failed In 4 trials.

I was looking at this study: http://www.ncbi.nlm.nih.gov/pubmed/24859203

Among patients who had experienced previous TNF antagonist failure, 15.2% of those given vedolizumab and 12.1% of those given placebo were in remission at week 6 (P = .433). At week 10, a higher proportion of this population given vedolizumab was in remission (26.6%) than those given placebo (12.1%) (nominal P = .001; relative risk, 2.2; 95% confidence interval, 1.3-3.6). A higher proportion of patients with previous TNF antagonist failure given vedolizumab also had a CDAI-100 response (≥100-point decrease in CDAI score from baseline) at week 6 than those given placebo (39.2% vs 22.3%; nominal P = .001; relative risk, 1.8; 95% confidence interval, 1.2-2.5). Adverse event results were similar among all groups.

Click to expand...

Still unimpressive though. Clinical remission, especially rates that low, does not excite me.

If it was not a biologic, that doctor would have not veto'd it, pentasa is harmless, vedoluzimab is a high risk medication. I realize people need medication, but they can't do this kind of stuff.

I wouldn't say Pentasa is harmless, but overall, I agree with your sentiment.

yes

(I don't mean Dusty when I said I don't like the news about it, I meant the company people behind this product claiming it works wonder for crohn's and promoting it like crazy, I like Dusty's posts)

Did they differentiate for different types of crohns?
I.e. Small vs. lg bowel.
I am at week 4of vedolimunab. Nothing much as far as improvement yet.
They tell you 6-10 weeks or more to see results and then it isn't even 50/50 but if you're ne of he lucky ones meanwhile I sometimes feel like its a con job to keep you or someone paying big time for the hope. How long do I give it and then what?
MTX, LDN? That's all I got left unless remi somehow works again!

I don't know of any trial that differentiated between small or large bowel, the ones I read incorporated CDAI scores instead of endoscopic results which makes them even more unreliable. Which is part of the reason behind the Veto, the fact CDAI scores are unreliable, and even wth CDAI scores, they could barely show an improvement over placebo, in some it did worse than a placebo and some studies were stopped.

There's a thread about this medication, where many people in it say they're still sick. The issue isn't just that this medication has a bad track record, the remission rates are much too low, the issue is that there needs to be honesty about how ineffective this medicaton has been in trials. Many people will deteriorate on this medication instead of improve, since the disease is not under control for those people.

Thanks Kiny. I don't disagree. I've seen that article before. It is 5 yrs old. But nevertheless vedolimunab has not shown compelling results.
And the results we read have probably already been fudged some. There's too much money at stake here and we are now the pawns in this game.
Before starting I did go through all the posts here and elsewhere regarding people's experiences and it wSnt that encouraging.
Anecdotally it seemed that UC and crohns colitis patients had better success than small bowel crohns patients.
I am in the former so with that and my GIs advice I am giving it a try.
Yes I have to use steroids to control the disease and it will be the ability to wean off the steroids that will determine if this drug works for me or not.
Unfortunately I have to give it about another 10 weeks on top of he five already to know.
GI says if we hit a plateau we introduce MTX. I said ok.
Humira for me didn't work after failing remicade after 9 good years on that.
When my former GI switched me over to humira he was quite confident so I spent 6 months getting worse while waiting and hoping for the humira to work. I had to tell him we can't just keep going like this at least lets try some pred. that helped so now I am steroid dependent but still have inflammation in the rectum although quite a bit less.
When the humira failed he referred me to a crohns specialist who is really good but only as good.

Robrich said:

Thanks Kiny. I don't disagree. I've seen that article before. It is 5 yrs old. But nevertheless vedolimunab has not shown compelling results.
And the results we read have probably already been fudged some. There's too much money at stake here and we are now the pawns in this game.
Before starting I did go through all the posts here and elsewhere regarding people's experiences and it wSnt that encouraging.
Anecdotally it seemed that UC and crohns colitis patients had better success than small bowel crohns patients.
I am in the former so with that and my GIs advice I am giving it a try.
Yes I have to use steroids to control the disease and it will be the ability to wean off the steroids that will determine if this drug works for me or not.
Unfortunately I have to give it about another 10 weeks on top of he five already to know.
GI says if we hit a plateau we introduce MTX. I said ok.
Humira for me didn't work after failing remicade after 9 good years on that.
When my former GI switched me over to humira he was quite confident so I spent 6 months getting worse while waiting and hoping for the humira to work. I had to tell him we can't just keep going like this at least lets try some pred. that helped so now I am steroid dependent but still have inflammation in the rectum although quite a bit less.
When the humira failed he referred me to a crohns specialist who is really good but only as good.

Click to expand...

Robeich, where abouts do you live, have you tried anti-map before or thought of it? It's a triple anti-biotic protocol which actually has higher remission rates than biologics... Just thought I'd share w ya

Josh, SoCal, yeah I've thought About the anti map and am watching the red hill study. Doesn't look that promising so far and the triple AB cocktail could be difficult to tolerate. I do think there is some bacterial trigger somehow involved and ABs have been and do help me a lot but can only tolerate them for so long.

Thinking more along the lines of playing out the entyvio for the next 4 mos . Possibly MTX and might go back and try remicade again if entyvio fails. Hoping enough time has passed to allow it to work again.
After that LDN maybe or whatever new treatment comes out.
With all the anti TNF failures there's a scramble for new treatments.
I also think at least for me that after being on anti tnfs for ten yrs once my body defeated them and found its way back to attacking itself it was that much stronger and tougher to fight.
When I started remi 15 years ago the results were so dramatic and so fast and I thought wow they finally figured this disease out and my 35 year ordeal was coming to an end.
Nah can't have that!

Have you had access to the redhill results? The trial doesn't end until late next year and it's double blind so I don't know how can say if it's promising or not? I did recently read a paper saying that patients were recommended to try remicade again after some time offi it. As for anti-map there are only a few people on this forum who are on it afaik but the majority of them that iv talked to have been doing extremely well on it. Whether or not that's because it kills map or just because they're macrophage penetrating I don't know. Either way, I hope you find remission soon!

Kiny- Vedolizumad does work in CD. The studies you are posting show results primarily at 6 weeks and some in week 10. If you move out to the 3 month mark and further the CD remission looks very good at about 50%.

Management doesn't' let newbies post links to studies :eek2: otherwise I would back it up but, take my word.

Christobol said:

Kiny- Vedolizumad does work in CD. The studies you are posting show results primarily at 6 weeks

Click to expand...

No they don't.

Failed in multiple trials at 6 weeks:

Hi Kiny. I am not arguing that vedo doesn't fail at week six. It is a miserable failure at week six. However the data shows that between 3 months and year the response rate is almost equal in CD as it is in UC. That means that people need to be patient on this drug.