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

Seanko

Senior Member
Messages
119
Location
Swindon, UK
Possibly something lost in translation.... Not vital to have 13page discussion about it (that would give me brain fog & make me flee)

Anyway, alternatives to Rituximab given Fluge/Mella hypothesis is correct? (Blood flow/lactate/antibodies)
 
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jimells

Senior Member
Messages
2,009
Location
northern Maine
I went to a talk given by Dr. David Bell, whom I'm sure you're familiar with, and while he too was excited by the results so far from the Rituximab studies, he thought it might take '20-30' years before it's approved by the FDA here in America.

Maybe he was exaggerating, or just speaking from 30 years experience w/fighting to get ME/CFS taken seriously. I can't imagine it would take that long, but wouldn't be surprised if it takes at least 10-15. Time will tell...

Considering that the CDC is *still* churning out useless studies based on Reeves cohorts and questionnaires, even while collecting data for the multi-site study, I can't help thinking that Dr Bell is correct.
 

A.B.

Senior Member
Messages
3,780
Possibly something lost in translation.... Not vital to have 13page discussion about it...

Anyway, alternatives to Rituximab given Fluge/Mella hypothesis is correct?

Methotrexate. It's cheaper but can also have serious side effects.
 
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EtherSpin

Senior Member
Messages
257
Location
Melbourne , Australia
Going back to the Fluge & Mella hypothesis on how Rituimab could work with ME/CFS...

New Scientist Summary of Paper

His team suspect that these antibodies may stop blood from circulating properly...preventing people from getting enough oxygen, explaining their extreme fatigue...

before getting into muscle stuff and mitochondrial bits, is this antibodies as obstructing alpha receptors or something like... what Im getting at is, is this speculating about orthostatic intolerance as well as all the other implications ?

I have EDS but very much a classical CFS presentation as well with lyme and herpes viruses aplenty - I'm tired of some specialists making out all the problems stem directly from OI as a function of my EDS as their medication and exercise recommendations in line with this have failed spectacularly.
 

Seanko

Senior Member
Messages
119
Location
Swindon, UK
@EtherSpin Asked the question on how Rituximab could work to activate somebody with more expertise eg @Jonathan Edwards

If the Fluge/Mella hypothesis is correct: antibodies starting a chain of events leading to less oxygen reaching muscles..... which could be averted by Rituximab halting the causal antibody production....

Are there alternatives to cancer drugs in the armoury of Rheumatoid Arthritis specialists which could do what Rituximab does but less harshly?

Hope you followed my train of thought!
 

Scarecrow

Revolting Peasant
Messages
1,904
Location
Scotland
@Seanko

In case, you haven't seen them, here are a couple of threads about other treatments Fluge and Mella are investigating:
http://forums.phoenixrising.me/inde...-with-six-intravenous-cyclophosphamide.37723/
http://forums.phoenixrising.me/inde...treatment-of-cfs-with-b-cell-depletion.37815/

The guanylate-cyclase is to provide short term relief, as F&M recognise the need to treat symptoms while waiting for rituximab or cyclophosphamide to take effect.

This is another thread you may like:
http://forums.phoenixrising.me/index.php?threads/rituximab-sub-study-assessment-of-flow-mediated-dilation-and-skin-microcirculation.32540/
 

Jonathan Edwards

"Gibberish"
Messages
5,256
@EtherSpin Asked the question on how Rituximab could work to activate somebody with more expertise eg @Jonathan Edwards

If the Fluge/Mella hypothesis is correct: antibodies starting a chain of events leading to less oxygen reaching muscles..... which could be averted by Rituximab halting the causal antibody production....

Are there alternatives to cancer drugs in the armoury of Rheumatoid Arthritis specialists which could do what Rituximab does but less harshly?

Hope you followed my train of thought!


Why would an anti-cancer drug be 'harsh'? The harshness of most anti-cancer drugs is due to them being very non-secific poisons, like mustine or vincristine. Rituximab is no more a cancer drug than aspirin really. It just blocks a different pathway. It works further upstream than almost anything, which has to be an advantage. The other biological drugs for RA tend to be more troublesome with risk of infection. Rituximab as it is used at present is not ideal for RA but it is close to ideal for autoimmune diseases that go into permanent remission like immune thrombocytopenia. It may be that some ME falls into that category.
 

Seanko

Senior Member
Messages
119
Location
Swindon, UK
@Jonathan Edwards Thanks for your reply.

Many of us have had experiences of relatives receiving chemotherapy as part of cancer treatment. My mother died 18 months ago after sessions of chemotherapy which made her completely bed ridden and prone to secondary infections. Looking back I wonder if her quality of life could have been better in the final few months.

That is why I used the word harsh.The drugs used were certainly much stronger than aspirin.

It was a grim experience for my mother & our family.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
@Jonathan Edwards Thanks for your reply.

Many of us have had experiences of relatives receiving chemotherapy as part of cancer treatment. My mother died 18 months ago after sessions of chemotherapy which made her completely bed ridden and prone to secondary infections. Looking back I wonder if her quality of life could have been better in the final few months.

That is why I used the word harsh.The drugs used were certainly much stronger than aspirin.

It was a grim experience for my mother & our family.

Yes, but rituximab has nothing to do with drugs like that. My rituximab patients generally felt no effects from it whatever. The dissolving of the B cells can produce a prickling feeling in the lymphoid tissue for about half an hour but that is about all.

I am sorry to hear your mother had a difficult time. I often wonder whether cytotoxic drugs are given at times when it would be better to allow the person to enjoy what they have left in the way of time without the effects of drugs. On the other hand my wife had chemotherapy for inoperable cancer forty years ago and it cured her so that she is still very well. She felt terrible one day a week for a year but it was worth it. The difficulty for the doctor is knowing how to make a judgement.
 

EtherSpin

Senior Member
Messages
257
Location
Melbourne , Australia
could we perhaps crowd fund a cruise ship that will stop at some Island that will give us methotrex and Ritux without a prescription so we can all IV up as we bask on the decks ?

Im only 85% kidding but am meaning to allude to the likelihood of CFS patients saving up for several month stints in foreign countries in order to have access to these drugs before their own countries lengthy testing and approval processes occur.
 
Messages
2,087
could we perhaps crowd fund a cruise ship that will stop at some Island that will give us methotrex and Ritux without a prescription so we can all IV up as we bask on the decks ?

Im only 85% kidding but am meaning to allude to the likelihood of CFS patients saving up for several month stints in foreign countries in order to have access to these drugs before their own countries lengthy testing and approval processes occur.

This does beg the question, lets assume a positive phase 3 trial from Normay published in 2018, could doctors prescribe Rituximab then ? If not what is the formal approval process, who makes an application and to what regulatory bodies and how long would it take? If this has already been discussed elsewhere aplogies, just let me know.
 

deleder2k

Senior Member
Messages
1,129
I think each country has a different set of rules. In Norway off label treatment is permitted. That means if a private hospital wants to treat people with Rituximab before it is approved against ME, it is permitted. There are special rules for off label use with respect to follow up, dosing and so on, but as long as a doctor says that there are sufficient evidence to use a medicine he is entitled to do so.


To get Rituximab approved against ME by the FDA and other regulatory bodies would probably take some time. I hope the phase 3 multi-centre study is sufficient, but I do not know. I guess it depends on what the data from the study say when it is published in 2017/2018.
 

heapsreal

iherb 10% discount code OPA989,
Messages
10,089
Location
australia (brisbane)
This does beg the question, lets assume a positive phase 3 trial from Normay published in 2018, could doctors prescribe Rituximab then ? If not what is the formal approval process, who makes an application and to what regulatory bodies and how long would it take? If this has already been discussed elsewhere aplogies, just let me know.


One thing I want to know is what's the diagnostic criteria for positive responders. This has to help prove the benefit to risk ratio of such a treatment . Also help making an economic decision .

Personally i would hate to shell out a small fortune , get side effects and still have ME.
after such studies i would hope they have better diagnostic criteria for rtx than just using something like the CCC criteria , although currently the best we have, its still too broad for this unless under the strict care in a research study.
 
Messages
2,087
Agreed, but a small fortune ( if you have it ) is nothing if it might cure ME. I would take the risk at odds of 60% in my favour.
I think the diagnostic criteria will be better understood by the time the phase 3 trial completes.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
One thing I want to know is what's the diagnostic criteria for positive responders. This has to help prove the benefit to risk ratio of such a treatment . Also help making an economic decision .

Personally i would hate to shell out a small fortune , get side effects and still have ME.
after such studies i would hope they have better diagnostic criteria for rtx than just using something like the CCC criteria , although currently the best we have, its still too broad for this unless under the strict care in a research study.
I think various groups are looking for markers that will indicate who will respond to rituximab. Particularly Fluge & Mella and the UCL group in London. But they haven't found anything yet, as far as we know.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
This does beg the question, lets assume a positive phase 3 trial from Normay published in 2018, could doctors prescribe Rituximab then ? If not what is the formal approval process, who makes an application and to what regulatory bodies and how long would it take? If this has already been discussed elsewhere aplogies, just let me know.

We have discussed it a bit but I am not sure anybody knows all the answers. Doctors can prescribe rituximab for ME in most countries if there is a source of funds and they are prepared to take on the responsibility of off label treatment. They are doing so in the USA and have done so in other countries.

Normally everyone thinks in terms of a licence for a drug for a disease. However, lupus has been treated for decades with all sorts of things and there are no licences for treating lupus (maybe one or two). If a drug company has a licence for a drug so that it can sell the drug to a pharmacy then the only real question is who approves the doctor taking it from the pharmacy and treating something else. In the UK in the NHS it is the body called NICE. Traditionally NICE works like the Medicines Control Agency that gives licences in that it asks the company to justify the treatment. However, this is completely illogical since what matters is not whether the company has a right to sell the medicine but whether patients are entitle to it as part of their public insurance system because it works.

I think that if the Norwegian phase 3 study comes out clearly positive there will be a sort of tsunami effect on decision making that will simply be unblockable. Government run health care systems may still drag their feet as much as possible but eventually they will be swept with the tide, as they have been in RA. If the pennypinching going on in the UK and elsewhere continues to tighten then there may come a time when this sort of thing just gets blocked - and that may be yet another reason to get private insurance as well for those not already daignosed! But as things are I think organisations like NICE will be put in a legal position they have never been in before. They will not be able to say - we will not fund yet because the company has not provided enough data, because the company has nothing to do with it.

Put another way, if the phase 3 study is clearly positive all the regulatory rules are irrelevant. We will be in a new ball park and PWME will be in a totally different position when it comes to pushing for treatment. I think a number of practitioners within government health care systems will make sure they find ways of offering the drug.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
But as things are I think organisations like NICE will be put in a legal position they have never been in before.
That's an interesting point. If the phase iii trial is successful then patients in the UK could seek a high court judgement against NICE if they refuse to license rituximab for ME/CFS, because they'd be denying treatment to patients despite excellent evidence that it's effective. And US patients can probably go through a similar process. I hope it doesn't come to that, but even the threat of legal action might make them sit up and take the situation seriously.