Phase III Rituximab Trial - News

[Gingergrrl]

Everything is not lost....we will stick together and try to keep fighting the good fight. It's a setback but we will get over it. As Carol Head from Solve always says 'Onward'.

Good for you @Sunshine3 and I agree with you that all hope is not lost. "Onward" is the only way to go and I am so proud of you and all you've been through to keep fighting and I really mean this. We are all rock stars!

 

[Alvin]

Very disappointing.
That said i'm not completely surprised, iirc they tried it on Whitney and it didn't work and he got worse shortly after, it may have actually made him worse (complete conjecture). Then i remember that @Gingergrrl saying she has never had PEM but has been a responder and started out with an intolerance (was it mold or is my memeory messed up)? So i expected a subset but it appears to be a very small one which i didn't expect, i assumed a statistically higher percentage
Finally they stumbled on rituximab because some patients did benefit, so the fact it does not work on many is even more perplexing, so it is likely there is a small subset because if it worked for some hence they discovery it has responders, the hard part will be determining why some respond but a majority don't.

 

[Jenny TipsforME]

I’ve woken up thinking about this (well I woke due to throat constriction and I’m now dwelling on it). It’s really winded me.

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.

Yes my partner’s response was that if it wasn’t that it made people worse (thinking of something like GET ) it could still be worth trying. It’s just now a very expensive personal experiment to probably not get a benefit.

but perhaps in the hope of some treatment in the near future, and of legitimacy (the deconditioning hypothesis would have been very difficult to reconcile with successful treatment with a monoclonal antibody!).

And thinking of context like the NICE review, it would have been a lot easier with a positive response (not that I was expecting rituximab on the NHS anytime soon) but it would have helped debunk flawed theories.

Anyway I’m going to turn on a murder mystery audiobook and hopefully go back to sleep (nothing calms me as much as a good murder ).

 

[Diwi9]

I was crushed by this news this morning. What is clear (to me) is that this disease is ill-defined and we are lumped together under the umbrella of "ME/CFS." We are different. Fluge & Mella may publish a paper that in fact helps a percentage of people to so that they do not receive an ME/CFS diagnosis. This group may have a treatment option with rituximab. If we can get a proper diagnostic test for them, it helps this group, and helps us clean-up our research studies. Wow, hope is a powerful thing...hate feeling crushed, again.

 

[Gingergrrl]

Then i remember that @Gingergrrl saying she has never had PEM but has been a responder and started out with an intolerance (was it mold or is my memeory messed up)?

Alvin, you are correct that I have never experienced PEM. I was given a diagnosis of "CFS" by several doctors in 2013 and told there was no treatment and believed this was my fate until I found PR. I used the word "PEM" in posts when I first joined PR in 2014, because I assumed that this was the word that fit with my diagnosis but I truthfully did not understand what it meant at that time. Once I understood it, no matter how hard I tried to make it match with my experience, it did not match. And after watching Jen in "Unrest" experience PEM, it became crystal clear to me that I have never experienced what she did.

Having said that, my daily functioning in 2014, until I began IVIG in 2016, was extremely low. I could not stand for more than 30-60 seconds without a wheelchair and could not take a shower without assistance. And tonight I shopped at two stores for Thanksgiving and walked around quite a bit without the wheelchair (maybe 20% of the trip)? It still boggles my mind. But my severe POTS, breathing issues, and orthostatic intolerance were the same every day. There was no amount of pacing or resting that changed them until I did IVIG and Rituximab.

You are also correct that I had toxic mold exposure in a former rental but I also had severe mono from EBV ten months before moving into the moldy rental (and had a neurotoxic reaction to an antibiotic the year before the Mono/EBV). So I had three hits to the immune system literally back to back and no way to know what caused what. The mold was a huge trigger but if I had not had severe mono ten months before, I might have been able to tolerate the mold better (or not, we'll never know). And then in 2015, I developed severe MCAS/allergic reactions.

What is clear (to me) is that this disease is ill-defined and we are lumped together under the umbrella of "ME/CFS." We are different.

I absolutely could not agree with you more. I almost accepted my fate in 2013 that I had "CFS" and there was no treatment until I found a new doctor who figured out I had Hashimoto's and severe POTS. This led me to keep searching and to find PR and my current doctor.

Fluge & Mella may publish a paper that in fact helps a percentage of people to so that they do not receive an ME/CFS diagnosis. This group may have a treatment option with rituximab. If we can get a proper diagnostic test for them, it helps this group, and helps us clean-up our research studies.

I agree and I think thousands of people are receiving an incorrect "CFS" diagnosis when they really have other medical issues, especially in the UK, but in the US and around the world, too. I think there is a group who can be helped by IVIG and/or Rituximab and this would not only help that group (like me) but would clean-up the research studies like you said.

 

[Alvin]

I agree and I think thousands of people are receiving an incorrect "CFS" diagnosis when they really have other medical issues, especially in the UK, but in the US and around the world, too. I think there is a group who can be helped by IVIG and/or Rituximab and this would not only help that group (like me) but would clean-up the research studies like you said

This is what i am thinking as well, i noticed there seem to be a cohort who have mold intolerance, chemical sensitivities and multiple allergies on the forums, i figured these may be the rituximab responder candidates. I don't have these issues so i'm probably not one of them
I hope Fluge/Mella realize this or someone runs the idea past them (anyone here know how we can make that happen)?

 

[Diwi9]

Well, if researchers don't figure subtypes out soon, one day we'll be called "ME/CFS Spectrum Disorder."

 

[Wolfiness]

Alvin, you are correct that I have never experienced PEM. … I used the word "PEM" in posts when I first joined PR in 2014, because I assumed that this was the word that fit with my diagnosis but I truthfully did not understand what it meant at that time. Once I understood it, no matter how hard I tried to make it match with my experience, it did not match. And after watching Jen in "Unrest" experience PEM, it became crystal clear to me that I have never experienced what she did.

I wonder if this is what's going on in Phil Hammond's GET clinic where he insists everybody has PEM ME.

 

[Gingergrrl]

I wonder if this is what's going on in Phil Hammond's GET clinic where he insists everybody has PEM ME.

I don't know what this means? I meant that each illness has certain unique terminology and when multiple docs told me that I had "CFS" in 2013 and 2014, and I had no idea what was wrong with me, I believed them. When I found PR, I thought "PEM" was the proper term to use until I figured out that it did not match my symptoms by asking tons of questions and doing my own research. Who is Phil Hammond?

 

[Gingergrrl]

This is what i am thinking as well, i noticed there seem to be a cohort who have mold intolerance, chemical sensitivities and multiple allergies on the forums, i figured these may be the rituximab responder candidates. I don't have these issues so i'm probably not one of them
I hope Fluge/Mella realize this or someone runs the idea past them (anyone here know how we can make that happen)?

Alvin, I am still thinking it is the people with auto-antibodies who are the potential responders but I have always wondered what is the overlap between autoimmunity and those with MCAS and/or toxic mold exposure?

 

[Kalliope]

I read in a Facebookthread from someone who attended Mella's lecture yesterday that he said about 30% had responded, not 50% or more, as was the limit for a positive study.

 

[MErmaid]

not match. And after watching Jen in "Unrest" experience PEM, it became crystal clear to me that I have never experienced what she did

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.

 

[adreno]

While this news is sad (as in we still don't have effective treatment), I agree that it is not all that shocking that the results turned out negative. Several important studies lately have found ME to be a metabolic disorder, and it is hard to see how rituximab could remedy that.

 

[Gingergrrl]

I read in a Facebook thread from someone who attended Mella's lecture yesterday that he said about 30% had responded

I don't actually understand what the final statistics are re: the responders but if it is 30% (from the Ritux group and not the placebo group), then I am very interested to learn more about that 30% and what auto-antibodies they had.

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.

When I went to the screening of "Unrest", in the Q&A after the film, Omar said that he and Jen fully understood that they were privileged to have family support, money, resources, etc, and that with great privilege comes great responsibility, and this is why Jen knew she had to make the film, for all of the people who did not have these things and could not make it.

Several important studies lately have found ME to be a metabolic disorder, and it is hard to see how rituximab could remedy that.

I fully agree that if ME/CFS is a metabolic disorder than Rituximab should not have any affect (vs. if it is autoimmune, killing B-Cells and stopping auto-antibody production makes sense). Maybe they did not find the answer for ME/CFS, but they might have found an answer for something, even if we don't know what it is yet.

 

[MErmaid]

When I went to the screening of "Unrest", in the Q&A after the film, Omar said that he and Jen fully understood that they were privileged to have family support, money, resources, etc, and that with great privilege comes great responsibility, and this is why Jen knew she had to make the film, for all of the people who did not have these things and could not make it.

I understand this. My views were not an attack on Jen or Omar, who are both incredible and amazing. It’s just that people who don’t have ME, or know much about it, may ignorantly assume that all PwME have support at home. They may assume we just need more research dollars, reduced stigma, while PwME are all being cared for at home.

It’s almost like playing back Unrest, but this time, watching Jen do it all alone. I think if this could be depicted someone, the outpouring of public support would come much sooner.

Edited to add:

I know this is off topic, but when I find the correct thread, I will move it over.

 

[Trish]

I read in a Facebookthread from someone who attended Mella's lecture yesterday that he said about 30% had responded, not 50% or more, as was the limit for a positive study.

Interesting given that PACE claimed great success for GET with their claimed 20% recovery rate. (which of course turned out to be an insignificant 7% on protocol specified criteria).

I hope we get more details soon.

 

[Kalliope]

Interesting given that PACE claimed great success for GET with their claimed 20% recovery rate. (which of course turned out to be an insignificant 7% on protocol specified criteria).

I hope we get more details soon.

Yes. But these numbers are for now just hearsay, and perhaps the person who attended the lecture misunderstood or remember wrong. We'll have to wait for more details.

 

[lansbergen]

I read in a Facebookthread from someone who attended Mella's lecture yesterday that he said about 30% had responded, not 50% or more, as was the limit for a positive study.

I said Rituximab is not for me and that still stands but a 30% response is not bad. Not good enough but something to look in further.

I asume they gathered lots of data. Maybe something shows up in that.

I am not disappointed. At least now I know it is not the majority that responses.

 

[Gingergrrl]

but a 30% response is not bad.

That was my reaction, too, and I want to learn more about the group who was in the 30%.

 

[Adrian]

Interesting given that PACE claimed great success for GET with their claimed 20% recovery rate. (which of course turned out to be an insignificant 7% on protocol specified criteria).

I hope we get more details soon.

It would depend on the size of the response. If 30% improved massively that would be good but if it was just a small improvement then that would seem less interesting. What seemed interesting from the previous trial was the amount of improvement that some people got but I think the numbers for the big improvements were still low.