Phase III Rituximab Trial - News

Daisymay said:
Or could it be one disease which manifests differently according to people's genetic make up/environmental exposure/initiating infection?
Click to expand...
Personally, I have no idea. But Lipkin's direct quote is
I think that ME/CFS is not one disease. There's going to be sub-types within it, and there will be a subtype who will respond to drugs that are directed against viruses, there's going to be microbiome focused efforts, there are things that will effect neurotransmitters
Click to expand...
Code: 
https://youtu.be/Rz9jaz350AI?t=11m43s
- copy and paste the link to be taken straight to the beginning of the quote in the video.
 
I think PEM is a term/symptom that we latch on to a little bit. I also think this can be present for other diseases (mitochondrial diseases? PA?). Crushing debilitating fatigue delayed following exertion can't be unique to one disease just doesn't seem logical (well to me anyway)

I also think that PEM means different things to different people and that this probably varies from person to person in terms of how it manifests itself.

I have the delayed sort 24-48 Hr and it has changed how it manifests itself (mainly cognitive now as oppose to crippling joint pain in the early days) and is much shorter lived than it used to be. I certainly haven't sprawled on a porch...but I haven't forced myself to crawl upstairs either? I think our stories are quite personal due to the nature of the disease but equally valid.
 
Jenny TipsforME said:
For example, when my body switches to fighting a new virus I get an unusual brainfog holiday just before the virus symptoms.

This could well be an entirely flawed perception but my experience is as if my body is mistaking part of me as a threat, until a more urgent threat is perceived and immune system attention is directed elsewhere.

That’s definitely not saying that viruses are a good thing for me. I’m sick longer than other people and my ME relapses have always been post viral (sometimes combined with too much activity).
Click to expand...
Just wanted to chime in to say I experience exactly the same thing, with a transitory reduction in symptoms before getting hit with full impact of a viral infection, I mean stuff like coughs and colds. Like you say, it is an improvement in cognitive function and sense of wellbeing, I’m more articulate in conversation, more likely to make social arrangements to catch up with friends or venture out of the house, which caught me out a few times before I recognised the pattern.

I too thought this might suggest some autoimmune or other aberrant immune activation process could be producing symptoms, which is temporarily interrupted by the immune system scrambling to deal with a new viral infection...

I also get everything going round, they are debilitating and last for weeks. The net effect is very much bad, but the prodrome is interesting and might lead to some insights into what’s going on, if anyone can work it out!
 
ivorin said:
As long as they understand who it was helping, it may prove useful none the less - just hope it doesn't scare off other researchers.
Click to expand...
I would have thought real dedicated researchers fully appreciate that's the name of the game they have chosen. They now know one route to not waste their time on, thanks to good scientists honestly reporting their findings.
 
BurnA said:
It's bizarre the way the first phase II trial had responders who relapsed shortly afterwards. And then in the second (unblinded) phase II the response duration increased after the maintenance doses.
So there was a link between dose and duration of response. Hard to believe it wasn't a genuine response.
Click to expand...
Be interesting to know in due course if anyone comes up with a reason for this. Seems clear now there was no hoped-for causal link. Was it just pure chance? Was there some other correlation hidden within the trial's method or application, that gave the illusion of a causal link?

Do trials like this do any follow up, to try and understand such things, and maybe everyone benefit from further understanding of tenuous false positives? Or is that not usually viable?
 
MErmaid said:
After watching Unrest, it was crystal clear to me that I experienced everything Jen did. This is what made it almost unbearable to watch, because it was too real, and a phase of my life I would rather forget. But I survived it all alone, I did not have an “Omar”, as Jen was fortunate to partner with. And I doubt I was the only person who had Jen’s version of ME, that survived in solo mode. I feel the true ME warriors are NOT the ones depicted in Jen or Ryan’s films, but the ones that survived and or continue to survive a version of hell in ME solitary confinement.

I think that’s THE message that needs to be broadcast. ME is not only a health crisis, that’s a hidden epidemic, but it’s also a horrible death row sentence for PwME that have no support at home.
Click to expand...
I ponder this also. My wife, I now realise, is relatively lucky - as lucky as anyone can be having ME :(. She is mild/moderate I think, and has family to support her, emotionally as well as physically. But there are so very many people without that support. It's why I feel so incensed at the naff pseudo-scientists who in a sense are stealing good people's lives; and why I really do believe forum's like ours are so important, for the mutual support, as well as playing our part in striving for good science and good justice. Many people here are clearly very strong inside, survivors, but there must be so many people with little or no support at all, nor even awareness of the possibility of support.
 
Sasha said:
Bear in mind that the patients' increased scores didn't necessarily mean that they were objectively better - only that they were rating themselves as better. That might indicate a shift in their way of thinking about their symptoms, rather than any change in the symptoms themselves.

This kind of thing in an open-label trial is why PACE is shit.
Click to expand...
I think @TiredSam was indulging in his special brand of wry humour.
 
Sunshine3 said:
Isn't PEM exclusive to ME. If you don't get pem, you don't have ME.
Click to expand...
It could conceivably be that only PwME exhibit PEM, but they may be a (majority?) subset, with other PwME still within the broader ME set, not exhibiting PEM.
 
Sasha said:
But there was no difference between the rtx and placebo groups in terms of the number of people who rated themselves better enough to be classed as 'responders'. That is, no one was 'responding' to anything.
Click to expand...

Does anyone know what the placebo was? It seems that since Rituximab is given via an IV, the placebo was probably saline. I personally respond very well to saline and wish I could find a doctor to prescribe it for me regularly (although I know that Dr. Edwards has claimed that there would be no benefit). What if the high placebo response rate had to do with the saline infusions. Do you think the research design accounted for that?

Lynn
 
Barry said:
It could conceivably be that only PwME exhibit PEM, but they may be a (majority?) subset, with other PwME still within the broader ME set, not exhibiting PEM.
Click to expand...

I asked this question a week or so ago: do people with genetic mitochondrial disease experience pem thinking they didn't since exercise seems to be an accepted benefit but I got several responses saying that genetic mitochondrial disease can cause pem... but once again it probably comes down to how people interpret PEM... first of all, in my experience the term should be PES (post exertional shutdown) as for me all systems seem to shutdown to a level that just keeps me alive while trying to conserve as much energy as possible)...and second I am very glad that a lot of research is being aimed at trying to figure out what is causing the obvious mitochondrial disfunction in what appears to be a large subset of sufferers
 
Lynn said:
Does anyone know what the placebo was? It seems that since Rituximab is given via an IV, the placebo was probably saline. I personally respond very well to saline and wish I could find a doctor to prescribe it for me regularly (although I know that Dr. Edwards has claimed that there would be no benefit). What if the high placebo response rate had to do with the saline infusions. Do you think the research design accounted for that?

Lynn
Click to expand...

I think Jo Edwards has previously said that the volume of rtx and therefore of saline is very low.
 
Lynn said:
Does anyone know what the placebo was? It seems that since Rituximab is given via an IV, the placebo was probably saline. I personally respond very well to saline and wish I could find a doctor to prescribe it for me regularly (although I know that Dr. Edwards has claimed that there would be no benefit). What if the high placebo response rate had to do with the saline infusions. Do you think the research design accounted for that?

Lynn
Click to expand...
I agree that the saline infusions could have provided some short-term symptom relief, for 1 or 2 days. But the main endpoint for evaluation of clinical effectiveness was, what was it... at 6 months, or something? So, the way the trial outcome was designed I don’t think that would have been a confounding factor.

I also suspect Rituximab is difficult to blind and most patients would have had an inkling they were on it... Though I’ve not tried it, so don’t really know for sure. Did the placebo patients get exactly the same pretreatment meds to mitigate any infusion related reactions, and all that rigmarole? I guess so.
 
You must log in or register to reply here.
Back
Top Bottom