Phase III Rituximab Trial - News

It's here https://clinicaltrials.gov/ct2/show/NCT02229942

 

I think that the aim of IiME/UCL was always to identify likely responders. Hopefully, they'll have some great data from Fluge and Mella's trial.

 

Any comments, @Jonathan Edwards?

 

Code:

https://twitter.com/MEAssociation/status/933010166760574976

https://twitter.com/user/status/933010166760574976

 

One good thing is that I do not think that this should be used against us - fortunately lots of patients stayed relatively cautious. [edit: Not that this will necessarily stop unscrupulous spin - but at least we didn't give them an open goal.]

It's obviously disappointing, as this seemed like our best chance of an imminent treatment, but it looks like we're just going to have to keep slogging on. Better to have rigorous research that reveals a disappointing result than poorly conducted research that leads to a misleading positive result. Very grateful to Mella and Fluge for all the work they've put in, regardless of the result.

IMO: At the moment the priority for us should be to keep pushing for high quality research, keep fighting against poorly conducted research with spun results. Maybe we'll get lucky with something else, but our best shot for genuinely useful interventions is to do what we can to pick apart the continuing flow of junk-science imo.

 

Statement from Invest in ME


For us we have invited the Haukeland team to Norwich to discuss the way forward.

We remain positive. Another setback, another day.

We have already been in discussion with our advisors and with the Norwegian team and we will meet to clarify the best way forward in the near future with our major funder and researchers.

We still have much good research being funded and being planned and feel our stategy is, and will pay off and lead to most rapid route to finding cause(s) of ME and effective treatments.

In another age, and in a struggle which has some parallels to that which is forced upon people with ME, these words strike a chord -


“ We must accept finite disappointment, but never lose infinite hope. ”

- Dr Martin Luther King

 

A more emotional response: Realistically, this was my last chance of an effective treatment while still able to pass as anything but middle-aged. So long healthy-youth, you were briefly quite fun!

 

Oh dear. Hope for this as future treatment had been keeping going in the back of my mind too (I don’t mean in a dramatic way, I’m upset not suicidal). But potential treatment around the corner takes away the dread of unrelenting crap ness. Literally

We should probably keep an eye out for pwme friends over the next week or so. Chase up anyone who isn’t online as much etc. I imagine I’m not the only one rituximab had this psychological function for.

There is this. I appreciate that they aren’t spinning this into a victory it isn’t. It shows integrity.

What I want to know is what is so different from stage two? Is it a different criteria? Different outcome measures?

 

Thanks for posting the news!

This is quite disappointing.
Although there were hints.

I also wish the very best for the researchers - I imagine this outcome may be frustrating for them, too - and I hope they will keep on doing real science on ME.

 

http://www.investinme.org/IIMER-Newslet-1711-03.shtml

Above is full statement from IiME

 

The primary outcome measure certainly looks very similar to the method they used for the phase II.

I'm not (yet) despondent about the news because all we know until publication is that rituximab "failed to be clinically effective" (quoting Marky90 at PR). It doesn't mean that rituximab is not effective for everyone with ME/CFS. We'll need to wait and see just how many people responded, who didn't and who got worse.

We always suspected that ME/CFS comprised several diseases. Clearly, phase III failed to reproduce the high responder rate in the earlier trials but many people always thought that would be too much to hope for. (Not me, I'm stupidly naïve and optimistic!)

 

Wasn't the dosages of Rituximab in the phase III trial a tad smaller than in the previous ones? Don't know what importance that has, though.

 

I'm assuming that there will still be responders, the question is how many.

What this phase III news means in practical terms is that we'll have more accurate knowledge of the proportion of responders than we did before. It means that the price of rituximab per response has just gone up. In the absence of being able to predict a response, the odds have worsened.

 

That made me cry. I am so depressed from this terrible outcome.

 

Yes, you're right. The follow up doses were fixed at 500mg, rather than being 500mg/m2 up to a maximum of 1000mg. Also the maintenance period was 'stretched out' slightly.

Phase II 'Materials and Methods
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129898

Phase III protocol
https://clinicaltrials.gov/ct2/show/NCT02229942

 

Sorry to bring you down! I'm basically middle-aged now, so it's not saying much. I looked back and thought my first post on this look irritatingly calm and positive about the bad news, so thought I should add in a little heart-ache too.

It's bad news, but we're still in a better position with research than we were five yeas ago. We're just going to have to keep slogging away.

 

ahhh - nothing makes me feel better than a good old fashioned slog......oh...wait

 

I think we need to allow ourselves to feel the disappointment but this quote in the Invest in ME response is one to remember



One day the research will get there but ok to today because it isn’t imminent

Re different phases:
Do we think there’s a placebo/demand characteristic type thing going on? If they were expecting positive results up until the unblinding it perhaps points to that? Did people in the placebo arm also respond?

But I always thought placebo was unlikely in the first two phases because of the weird delayed response, which I don’t think participants would know to expect. Need to wait for more info.

I guess my question is: does this work at a biological level for fewer pwme than we hoped OR was it a false positive that it worked in the previous studies?

Will other studies now not go ahead? @Jonathan Edwards @Jo Best

 

I have suffered from ME for over 20 years. It was first when Fluge/Mella published their small Rituximab-trial back in 2011 that I started to develop a sincere hope for a better life - to receive a cure, or at least treatments, sometime in the future.

The news today are disheartening indeed, but there is so much going on now when it comes to ME-research, that even though I am disappointed of course, my hope at least isn't shattered.