Entyvio and biologics clinical trial data: where is the efficacy?...

Having gotten nothing out of FMT, the remaining options look like Entyvio or colectomy. I decided to have a read through pubmed of the clinical trials. Let's take a few stats from a study which compiled all Entyvio (vedolizumab) data from its beginning to June 2014 (release).

"After 4 to 6 weeks of therapy 77% (293/382) of vedolizumab patients failed to enter clinical remission compared to 92% (205/224) of placebo patients "

"After 52 weeks of therapy, 54% of vedolizumab patients had a clinical relapse compared to 84% of placebo patients"

So, only 23% of Entyvio patients as opposed to 8% placebo achieved remission... that seems terrible. Additionally, it's more likely than not I'll relapse within a year of starting Entyvio. I understand statistics, but I don't understand how these "wonder drugs" are considered as changing the treatment landscape.

I thought "maybe they just needed to monitor at 10 weeks or 14 weeks to see the good results?" Not so.
"At every assessment from day 29 through day 253, over 50% of vedolizumab-treated patients were in clinical response, while placebo response rates generally ranged between 22% and 33%"

Only 50% are responding (while about half as many are doing so on placebo)? How can that be?

So I decided to look at Remicaid to get some context. Long term response 53% and 24% in the infliximab and placebo groups... clinical remission was not statistically significant between the two.

I asked my GI about this yesterday, and he says that clinical experience suggests they work more often than what is suggested in the trials... but the trials are very discouraging.

What do you guys make of this? If this is true, I don't see the use in trying Entyvio.

I think you have discovered the truth behind UC in general. NO treatments have great success rates. That's why many posters here talk about the biologics as if they were candy. Remicade doesn't work? Try Humira. If that doesn't work try Simponi. If that doesn't work try Cimzia. If that doesn't work try Entivyo. If that doesn't work..............That's just talking about the biologics. You can say the same thing about all of other treatments options as well, including the alternative. When you add all of these success rates together (as in if one doesn't work another might) you might reach a very high percentage (let's say 75%) of remissions and yet probably at some point 25% of all patients will eventually need surgery.

Yeah, sad but true, no single treatment for uc works for all patients. It's part of the reason combination therapy is used (I.e. multiple drugs are taken simultaneously). However, don't let it discourage you. I recommend you try entvyio as it might work for you.

Some notes:

The maximum length of the clinical studies is a year. For some, it takes longer than that time period to achieve remission. It took roughly a year for remicade to give me remission.

Regarding placebo patients, uc can spontaneously go into remission on it's own. Also, people in the study are allowed to be on other uc drugs simultaneously with the one being studied. So the placebo didn't put them into remission, but the imuran they were on did.

I don't believe that UC can go into remission "on its own" - there always has to be some catalyst for it... be it meds or just the belief that you are taking something that can help you (sugar pill).

Please do note that the placebo effect isn't just limited to UC studies, but in a broad range of studies covering all conditions. It is still a million dollar question that needs further investigation.

On the topic of biologics, some study arms exclude those taking other medications. The thing is that if mesalamines/immunosuppresants aren't putting people in remission (which would explain why they entered the trial in the first place), but the combination of that and the sugar pill "coincidentally" does, then it does warrant further study on what is happening. Depending on the type of study it is, there is almost always exclusion criteria for medications.

Unfortunately, I feel this falls beyond what our current scientific realm has to offer... there is tremendous bias, as data is often influenced by the funding pharmaceutical company, and as such, we should expect the results to be cooked in many ways.

Best.

To me it is a very simple question and answer.

I am very attached to my colon and the rest of my body. I DO NOT plan on losing anything I do not absolutely have to. So in the case of UC I am going to try every drug on the market and see what works for me. I also have a pretty high threshold I am going to have to cross before I consider more drastic actions.

Just to play devil's advocate, several UC treatments can have very serious and even life threatening side effects that can be far worse than colon removal surgery. There have been many who lived a life of pure hell, sometimes for decades, finally accepting surgery and then kicking themselves for being so stubborn and not doing it sooner.

Biologic therapy seems like an ineffective long term plan for how much cost and hype goes into them. From the data and anecdotes I've read, the idea is that you're supposed to take these drugs to maintain remission for life, but it seems like most people get a few months or years before they inevitably fail them or build up antibodies. I know Judy has had 8 years on Remicade, which is amazing and I hope it continues indefinitely, but how often do you hear that?

Tunnelvisionary said...
Biologic therapy seems like an ineffective long term plan for how much cost and hype goes into them. From the data and anecdotes I've read, the idea is that you're supposed to take these drugs to maintain remission for life, but it seems like most people get a few months or years before they inevitably fail them or build up antibodies. I know Judy has had 8 years on Remicade, which is amazing and I hope it continues indefinitely, but how often do you hear that?

Then I suppose nobody should take lialda, apriso or asacol hd either? I mean look at these lousy numbers:Apriso® 1.5g daily was compared to placebo over a 6 month period4. Remission rates at the end of the study were 79% in the Apriso® group and 58% in placebo (P<0.001).

Of course whipworm (trichuris) ..but it will take more research ..hopefully the big pharma will not succeed in blocking or. Confusing these research studies about alternative treatments. Bio logics are billion dollar business ! Whipworm ova are very cheap ! You infect your colon with whipworm once and treatment is over. Let's wait and hope it works.