New Rituximab ME/CFS open-label phase II study with rituximab maintenance treatment

[worldbackwards]

What "trials"? There are no ongoing US rituximab trials.

I dunno. It was a brief comment in an article about an "ME Question Time" meeting in Kingston. @charles shepherd was there, so maybe he can help.

 

[BurnA]

Spotted this in the latest "ME Essentials" magazine:

A bit worrying, I thought. Do we have any corroboration of this?

Someone brought this up on a thread recently ...they said they heard it from a doctor of theirs. Bottom line is there are no trials in the us and an e-mail from omi said they were seeing similar results to those in Norway.

For what its worth, I sent an email asking the clinic at Stanford what their results with Rituximab were like, and they responded, "Similar to published data... however it's early and there's a lot of variability across patients."

I thought I deleted their response on accident, so I sent another email asking the same question, and this is how they responded,
"Thanks for your inquiry. Please see Dr. Kogelnik's response below:
This data is very rough, but basically we are seeing results that are on par with the Norwegian published data.
AK"

 

[perrier]

Surely, there must be some word out about how the study is going in Norway. Does anyone have news?

Also, the doctor, who is trying rituximab here in the USA must also have some information about what works and for whom.

Is there no way for us to get some information.

So many folks are suffering horrifically.

Last question: how many IVs did it require for some of the patients to respond favourably?

Please post whatever information about this trial and about USA effort

 

[A.B.]

Surely, there must be some word out about how the study is going in Norway. Does anyone have news?

It's randomized and blinded. Nobody knows how it's going. If somebody knew it would be cause for concern.

 

[BurnA]

Surely, there must be some word out about how the study is going in Norway. Does anyone have news?

Also, the doctor, who is trying rituximab here in the USA must also have some information about what works and for whom.

Is there no way for us to get some information.

So many folks are suffering horrifically.

Last question: how many IVs did it require for some of the patients to respond favourably?

Please post whatever information about this trial and about USA effort

All the information is available on these forums under rituximab. The papers for the phase 2 trials are online.

Unfortunately we will not know about the phase 3 trial result until early 2018 more than likely.

Nobody has identified who will respond or not.
There is research work ongoing in ucl relating to this but so far there is no outcome.

Sorry but there is no more news ...we all want the same but nobody knows.

 

[Research 1st]

It's worth remembering that someone with a clinical diagnosis of 'CFS' may have in addition (or isolation) an undiagnosed POTS or Lyme disorder, and not have the autoimmune subset in CFS at all, or both, or triple conditions all at once.

If and when we hear of people going back to work, or having some kind of life again on Rituximab, be cautious that we don't know yet know how to immunologically select this group of recovered patients as similar or dissimilar to us.

Then add the fact of additional diseases acquired, and longevity. Was the person ill for 5 years or 50 years? It would make sense that overtime, the immune system in some subsets becomes damaged, and that B Cell depletion simply won't work, or is too risky to even attempt if the patient is very weak and/or very chemically sensitive/hyper allergic.

Without wanting to sound dictatorial (apologies if I am) I feel it's worth being realistic over B Cell depletion working for the reason you, personally, are sick rather than getting your hopes up, only for them to be dashed.

Having said that, it's fantastic a subset of patients may be helped significantly or even 'cured' and that is a great moment for the legitimacy of any disease in general, and the folk with forms of the disease who can get some of, or most of their lives back.

Certainly with a subset back on their feet, they will become an effective force for health advocacy also.

 

[Marky90]

Certainly with a subset back on their feet, they will become an effective force for health advocacy also.

Indeed, I have long decided that i will devote my life to fighting for ME-patients when I`m back in the game (I study law).

It will be awesome if we soon find out what`s going on with the subset not responding. I think the hypothesis that in some people the plasma cells aren`t sufficiently cleared out, sounds plausible. And it might be why some only respond in moderate fashion.

Or, it`s something else entirely.

We fill find out.

 

[BurnA]

It's worth remembering that someone with a clinical diagnosis of 'CFS' may have in addition (or isolation) an undiagnosed POTS or Lyme disorder, and not have the autoimmune subset in CFS at all, or both, or triple conditions all at once.

If and when we hear of people going back to work, or having some kind of life again on Rituximab, be cautious that we don't know yet know how to immunologically select this group of recovered patients as similar or dissimilar to us.

Then add the fact of additional diseases acquired, and longevity. Was the person ill for 5 years or 50 years? It would make sense that overtime, the immune system in some subsets becomes damaged, and that B Cell depletion simply won't work, or is too risky to even attempt if the patient is very weak and/or very chemically sensitive/hyper allergic.

Without wanting to sound dictatorial (apologies if I am) I feel it's worth being realistic over B Cell depletion working for the reason you, personally, are sick rather than getting your hopes up, only for them to be dashed.

Having said that, it's fantastic a subset of patients may be helped significantly or even 'cured' and that is a great moment for the legitimacy of any disease in general, and the folk with forms of the disease who can get some of, or most of their lives back.

Certainly with a subset back on their feet, they will become an effective force for health advocacy also.

Yes we will have a lot more able bodied advocates, If I ever get better I can tell you now I will do everything I can to bring the PACE authors to justice and fight for ME research.

However, I agree ...Nobody knows who will respond and I am not expecting anything...

 

[Marky90]

It's worth remembering that someone with a clinical diagnosis of 'CFS' may have in addition (or isolation) an undiagnosed POTS or Lyme disorder, and not have the autoimmune subset in CFS at all, or both, or triple conditions all at once.

Btw new research suggests POTS might be autoimmune, so if you`re misdiagnosed, you might respond rtx anyway.

I think the hard one is that some diagnosed with ME might have lyme, and vica versa. Hopefully the diagnosing of lyme disease will improve in the coming years as research progress.

 

[perrier]

What news is there about folks who have tried rituximab in the USA

 

[perrier]

I've never quite understood why a person would have two horrific illnesses. And the spinal fluid testing showed differentiation between the two conditions. Yes, they can resemble each other. It may be the testing is leading us astray.

 

[perrier]

I recall when several of us sat on the edge of his or her seat when Montoya was doing his valcyte work. My daughter didn't qualify as her viral titters were just a little under their cut off point. Do you think this rituximab excitement is something totally new, something that will help thousands.....I'm still having trouble with the subset issue. When someone has this illness there are basic similar problems.....

 

[BurnA]

I recall when several of us sat on the edge of his or her seat when Montoya was doing his valcyte work. My daughter didn't qualify as her viral titters were just a little under their cut off point. Do you think this rituximab excitement is something totally new, something that will help thousands.....I'm still having trouble with the subset issue. When someone has this illness there are basic similar problems.....

I know you are concerned so I will answer this as best I can however this is just my opinion.

RTX as a treatment for ME is new - it's currently in phase 3 trial and no matter how many questions you ask we won't know any more about this until 2018. However from the phase 2 trials it looks like 50-60% of people get a response. The response is varied from major to moderate and also in duration so there are a lot of unknowns and nobody knows why some people respond better than others.

One theory is that there are subsets of patients - these subsets may all have different underlying diseases - hence the non responders subset. However this is a theory only. It is also possible rtx is not effective in some patients for another reason. We don't know.
You are correct about many of the underlying symptoms being the same across patients so it could easily be that most patients have the same disease but rtx is not effective in everybody. We don't know though.

That's all I can add, but if you search the threads on rtx and also cyclophosphamide you will learn more.

 

[perrier]

I know you are concerned so I will answer this as best I can however this is just my opinion.

RTX as a treatment for ME is new - it's currently in phase 3 trial and no matter how many questions you ask we won't know any more about this until 2018. However from the phase 2 trials it looks like 50-60% of people get a response. The response is varied from major to moderate and also in duration so there are a lot of unknowns and nobody knows why some people respond better than others.

One theory is that there are subsets of patients - these subsets may all have different underlying diseases - hence the non responders subset. However this is a theory only. It is also possible rtx is not effective in some patients for another reason. We don't know.
You are correct about many of the underlying symptoms being the same across patients so it could easily be that most patients have the same disease but rtx is not effective in everybody. We don't know though.

That's all I can add, but if you search the threads on rtx and also cyclophosphamide you will learn more.

Thanks ever so much for your time and response. My frustration and anger are shared by many who watch all this and need urgent relief. It's such a horribly long wait. Surely, news must leak out. I'm sure doctors who have contact with Fluge Mella hear stuff. And I can't find out much about what results are with folks trying this in the USA. Non stop I invoke aids. Boy did research ever pull together on that. Here we have thousands upon thousands of broken young lives, and there are still physicians like the one a few weeks ago, a prominent fellow too, who described this as psychosocial. Thanks again

 

[SOC]

Surely, news must leak out. I'm sure doctors who have contact with Fluge Mella hear stuff.

We do not want to encourage information to leak out. Is important that this research is done properly and without being compromised by our understandable wish to have information sooner.

The reality is, we have no solid conclusions about Ritux yet. The research needs to be completed and that's going to take time, whether we like it or not. We just have to be patient about the ongoing research and do the best we can with the treatments that are currently available to us.

 

[ScottTriGuy]

...
The reality is, we have no solid conclusions about Ritux yet. The research needs to be completed and that's going to take time, whether we like it or not. We just have to be patient about the ongoing research and do the best we can with the treatments that are currently available to us.

Patience would not have saved tens of millions of HIV+ people globally.

We don't have to be patient either.

Many of us put handfuls of (barely tested) supplements into our bodies - on our own volition.

We should have the same choice to take Rituximab, with its well known safety profile.

Perhaps we need an ME Buyers Club.

 

[L'engle]

Patience would not have saved tens of millions of HIV+ people globally.

We don't have to be patient either.

Many of us put handfuls of (barely tested) supplements into our bodies - on our own volition.

We should have the same choice to take Rituximab, with its well known safety profile.

Perhaps we need an ME Buyers Club.

SOC was speaking specifically about the need to be patient with regard to finding out about the stage III trial, in the interests of the research trial's integrity.

I feel patient about waiting for research trials. What will make me impatient is if even after the trials are successful (if they are) we still have to wait ages for it to be readily available and affordable. That could potentially be the longer and more infuriating wait, especially for those of us who don't have much money, which is most of us.

I think you can get it now if you are able to pay

 

[ScottTriGuy]

SOC was speaking specifically about the need to be patient with regard to finding out about the stage III trial, in the interests of the research trial's integrity.

I feel patient about waiting for research trials. What will make me impatient is if even after the trials are successful (if they are) we still have to wait ages for it to be readily available and affordable. That could potentially be the longer and more infuriating wait, especially for those of us who don't have much money, which is most of us.

I think you can get it now if you are able to pay

Gotcha, thanks for clarifying @SOC comment intent for me.

I already pay for it - with my taxes - the govt wants us to pay again.

I want Minister of Health Dr Jane Philpott to make Rituximab available to ME patients. She can do that with a flick of her wrist.

If she can show leadership and co-chair the immigration of 25,000 Syrian refugees in 6 weeks, she can take 5 minutes to learn about the dire ME situation in her portfolio and make Rituximab an option for 400,000 Canadians.

 

[perrier]

We do not want to encourage information to leak out. Is important that this research is done properly and without being compromised by our understandable wish to have information sooner.

The reality is, we have no solid conclusions about Ritux yet. The research needs to be completed and that's going to take time, whether we like it or not. We just have to be patient about the ongoing research and do the best we can with the treatments that are currently available to us.

Scientifically I understand. Emotionally and spiritually I don't. The world really moved on aids. There were tests and research projects all over. Here we have two courageous Norwegian fellows. And this is it...

 

[SOC]

Scientifically I understand. Emotionally and spiritually I don't. The world really moved on aids. There were tests and research projects all over. Here we have two courageous Norwegian fellows. And this is it...

AIDS activists will tell you that they had a too long delay before the world took up their cause, just as we are currently experiencing . Even after a big push started, it took years for the science to sort out what was going on and for medications to be developed and tested. It didn't happen overnight for them, either.

It's miserable and unfair to have a serious disease in the pre-acceptance stage. It feels wrong that we have to wait years for big things to happen while we continue to suffer. But that's the way life works. We can't make the Ritux trial happen any faster than it is. All we can do is push to get more research started sooner so that overall the knowledge base increases faster. It's still going to take years to perform the research. In the meantime, we do what AIDS patients did at the same stage, make the most we can of the treatments available to us -- AVs, abx, hormone supplementation, OI treatments, immune modulators, and so on. They're not cures and they're sure as heck not perfect, but they're what we have while we wait for a cure.