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

[SOC]

Hmmm...I'd like to know what they are (for CC definition ME). And how to disentangle the effects of treatment from natural fluctuations of the illness. But this is getting this thread off topic.

My daughter and I have the ICC defined illness. She has gone from about a 5 to 9.5 on the PR scale. I've gone from 1 or 2 to 6 or 7, both of us under the treatment of ME/CFS specialists. So it's possible for some of us, at least, to get significant improvement. Our improvements were not natural fluctuations in the illness. We were getting worse before treatment, improved with treatment, stay generally improved on treatment, and regress when we stop treatment.

I agree this is OT for the thread, so we can quit here. I just wanted to make sure that other patients know that improvement is possible with the right treatments for the particular patient. There is hope for a better QOL.

 

[jimells]

I´m sorry that they didn´t work, but it just shows what a lottery the NHS is - I have found reports of the NHS treating people with Chronic Yersinosis (my diagnosis), but when I asked my GP about this possibility he said he wouldn´t even know who to refer me too, and it ended there.

It is much the same in the US, even with a very different payment system. A few years ago I took antivirals for 8 months with no effect, including the very-expensive Valcyte. The Medicare prescription drug program paid for them without a peep or any special authorizations, and Medicaid paid most of the out-of-pocket expenses. Of course I did have to travel 1000 miles round trip to find someone to prescribe the drugs, and it was nearly impossible to deal with a physician located so far away, so ultimately I was forced to abandon that line of treatment.

Meanwhile the local primary care physicians will hardly give me the time of day ("Come back in six months so we can continue the non-treatment"), and the current one has refused to write a standing order for IV Saline at home or the cancer infusion clinic (for POTS). Meanwhile the local ER physicians will order IV saline anytime I show up and ask for it. Unfortunately that means going to the ER and maybe getting a bed right away, or maybe waiting a long time.

Half the doctors I have seen tell me they can't help and they don't know who can, like your GP, and the other half tell me I'm not sick - I just need exercise and therapy.

 

[L'engle]

So doe anyone know if the rules of the trial mean we have to wait till 2018 to hear anything at all, or if some information might be legitimately released sooner? (not leaked or rumored but openly reported)

 

[BurnA]

So doe anyone know if the rules of the trial mean we have to wait till 2018 to hear anything at all, or if some information might be legitimately released sooner? (not leaked or rumored but openly reported)

It's blinded until 12 months after the last patient gets the last infusion. I wouldn't expect to hear anything before then, and probably 6 months after that.

 

[L'engle]

Thanks @BurnA So I guess that is next May at the earliest or likely next November. Thanks!

 

[BurnA]

Thanks @BurnA So I guess that is next May at the earliest or likely next November. Thanks!

Sept 17 is approx 12 months after the last patient gets last infusion so I would expect news sometime Q1 or Q2 2018.

 

[L'engle]

@BurnA sept 17 of 2016?

 

[BurnA]

@BurnA sept 17 of 2016?

2017. The study commenced in 2015 but the last patient got their first infusion sometime around September I believe. So 24 months from Sept 2015 to wait for unblinding then add 6 months for write up etc.

 

[L'engle]

Oh OK, for some reason I read last patient's first infusion. OK so basically have to wait out the whole thing. Thanks! 2.5 years of Jeopardy music on loop.

 

[John Mac]

Hopefully we might hear something from the cyclophosphamide trial before then

 

[BurnA]

Hopefully we might hear something from the cyclophosphamide trial before then

Yes we should, this should be complete by end 2016 so publication early 2017.

 

[perrier]

My daughter and I have the ICC defined illness. She has gone from about a 5 to 9.5 on the PR scale. I've gone from 1 or 2 to 6 or 7, both of us under the treatment of ME/CFS specialists. So it's possible for some of us, at least, to get significant improvement. Our improvements were not natural fluctuations in the illness. We were getting worse before treatment, improved with treatment, stay generally improved on treatment, and regress when we stop treatment.

I agree this is OT for the thread, so we can quit here. I just wanted to make sure that other patients know that improvement is possible with the right treatments for the particular patient. There is hope for a better QOL.

This is extraordinary. To go from a 5 to a 9.5 and from a 2 to 7!!! Bravo. Is it possible to let me know the name of your treating physician? Thanks very much!

 

[SOC]

This is extraordinary. To go from a 5 to a 9.5 and from a 2 to 7!!! Bravo. Is it possible to let me know the name of your treating physician? Thanks very much!

We started with Dr Lerner. After several years we switched to Dr Rey, who is Dr Klimas' associate at INIM.

 

[perrier]

We started with Dr Lerner. After several years we switched to Dr Rey, who is Dr Klimas' associate at INIM.

Where is Dr Rey? I'm Canadian. Also, would be too intrusive to inquire what stuff you are on?

 

[perrier]

We started with Dr Lerner. After several years we switched to Dr Rey, who is Dr Klimas' associate at INIM.

And of course, the question becomes: why aren't all folks getting these lifts?

 

[SOC]

And of course, the question becomes: why aren't all folks getting these lifts?

Many who see these doctors and are able to follow their treatment plans are getting substantially improved quality of life. Others don't, however. I doubt all of us have the same illness, so treatment that works for some likely won't work for others. I would guess that those who have a similar pattern of illness to that of my family and are able to tolerate all the treatments would have a similar result, but who knows?

Where is Dr Rey? I'm Canadian. Also, would be too intrusive to inquire what stuff you are on?

Dr Rey is with The Institute of Neuroimmune Medicine (INIM) at NOVA Southeastern University in Miami FL. She is not currently taking new patients, but INIM might have another doctor with a currently open practice. The best specialists fill up fast and have long waiting lists.

I will PM you about the treatments we have taken. Keep in mind this didn't happen overnight. It's necessary to test for abnormalities and try different things to see what works.

 

[RYO]

I think the mitochondrial theory isn't on very solid footing in general. Doctors see fatigue as the defining symptom of ME because of the inappropriate use of the term CFS or even CFIDS. This prevents them from really understanding the disease. If you say there is a problem with fatigue, it's not hard to get to the point of thinking there is a problem with energy production, and of course we all learned in biology 101 that mitochondria are responsible for energy production, so we blame mitochondrial dysfunction.

There are a number of diseases with mitochondrial function (genetic in origin, passed mother to child generally). They do not look much like ME.

I think one possible explanation for reduced exercise capacity and VO2 max may be poor delivery of blood to tissues. There are many possible explanations for this, but endothelial dysfunction (being studied by the Norwegians in the phase III trial) is among them. Some kind of a vasculitis could be involved, as could problems with angiogenesis (there are some small studies showing reduced VEGF in ME patients and quite a few showing reduced plasma volume).

I have often wondered whether a post viral vasculitis could be a potential mechanism to explain the varied manifestations of ME. Myalgia, fatigue, fevers, and arthralgia are all reported symptoms of small vessel vasculitis. My legs chronically ache but much worse with exposure to cold - cryoglobulins?. The skin over my legs more sensitive. After exposure to hot water, there is a transient rash that has the appearance of livedo reticularis.

It feels like PEM is manifestation of exacerbation of reduced plasma volume. ??? pooling of blood in mesenteric vasculature and lower extremities.

However, the usual signs of inflammation such as ESR, CRP, complements levels, RF all normal.

How do we go about identifying the autoimmune antibodies triggering vasculitis or endothelial dysfunction?

 

[halcyon]

I have often wondered whether a post viral vasculitis could be a potential mechanism to explain the varied manifestations of ME.

People like Byron Hyde and Erich Ryall have been saying this for a while.

You might find Ryall's paper on the Sacramento outbreak interesting.

 

[BurnA]

In Dr. Naths recent talk on the NIH study he said the following :

For example two studies from a group in Norway showed delayed clinical improvement in patients following treatment with Rituximab which is a monoclonal antibody that depletes B cells. However these studies were small and the immune profiles were not measured in these patients.

I am surprised to hear him say the immune profiles were not measured in these patients. I would have assumed that between Norway, Germany and UCL, that the immune profile of the rituximab patients was well measured.
Was I wrong to assume this or what was Dr Nath implying ?

 

[Jonathan Edwards]

In Dr. Naths recent talk on the NIH study he said the following :



I am surprised to hear him say the immune profiles were not measured in these patients. I would have assumed that between Norway, Germany and UCL, that the immune profile of the rituximab patients was well measured.
Was I wrong to assume this or what was Dr Nath implying ?

The Norwegians were pretty thorough in their immunology. They may not have published all of it because they found very little. It sounds as if Dr Nath may not have talked to them directly, which I would have thought was essential prior to starting a study like this.