Phase III Rituximab Trial - News

Gingergrrl said:
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?
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I could be remembering wrong, but I recall @Jonathan Edwards making a comment on PR a while back about how some with an autoimmune disease (i forget which specific disease he was refering to) seem to describe symptoms that sounded very much like PEM.

I may be remembering wrong though.
 
TrixieStix said:
However doctors now suspect I could have a rare autoimmune disease called "Relapsing Polychondritis" (RP).
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What is "Relapsing Polychondritis" (RP) and how do the symptoms present? (I apologize, I do not have time to Google it right now but plan to later).

TrixieStix said:
I was also just diagnosed with a rare genetic partial Complement C3 deficiency (my C3 is only 30% of normal) and partial C3 deficiency can in some instances cause a "Lupus-like illness".
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I have been so curious what ended up happening with your C3 (and C4?) deficiency? Is that definite and is Plaquenil the main treatment? I plan to re-read your posts later. Does Dr. Chheda feel you have ME/CFS, and these additional diagnoses, or is she not sure at this point? It is so challenging sometimes to sort it all out.

I am keeping you in my thoughts as you proceed and please keep me posted :hug:
 
@Barry - re the battery analogy - I said to my husband that my alternator is faulty! The battery won’t charge up and it won’t stay charged... it doesn’t matter how much I try to recharge, because the alternator is broken, the battery runs down really quickly! (Obviously he is a car nut!)
 
Sorry I haven't the brain power available just now to quote from the thread, but just to add my tuppence about PEM - you know how it is when you do a web search for one thing and happen across other interesting info? I was surprised to find info on rare diseases using the phrase 'exertion intolerance' and other descriptions that sound very like ME/CFS PEM - with the exception of the 'flu-like' flare which I feel is better defined by the ME ICC term PENE (post-exertional neuroimmune exhaustion).

I had always thought it's not specific enough to describe PEM as 'post-exertional pain or fatigue' - I realise that's how some people with ME/CFS experience their PEM as it depends on our own symptom profile, it's just that unless they've been thoroughly investigated for other possible causes such as rare genetic diseases, which may onset in adults, they can't be sure.

I think DNA testing will be really important to people diagnosed with, and researching ME/CFS, and while I don't trust the proposed UK MEGA project, I am hopeful on the ME/CFS Genes project run by Nancy Klimas' team: http://www.nova.edu/nim/research/mecfs-genes.html
 
Rough English translation (courtesy of Anna Mitchell in IiME Research Facebook group) of this article in Aftenposten:
https://www.aftenposten.no/norge/i/dd50mz/Nedslaende-forskningsresultat-for-ME-pasienter

Disappointing Research Outcome for ME Patients

There was great excitement about whether the cancer drug Rituximab would help ME patients. Now the main conclusion is clear.

The whole preliminary findings were presented at an ME conference this week. Researcher Olav Mella at Haukeland University Hospital announced the unpublished findings for the sake of ME patients who were hoping for treatment.

The conclusion is clear: It is not possible to demonstrate the effect of Rituximab on the sample of patients who participated in the multi-center study, called RituxME.

The results will only be published in the spring

The scientific article about the study will probably be published in early 2018, and Mella does not want to comment on the case, or say more about the study now.

Aftenposten has previously written about research that investigates whether cancer medicine can cure chronic fatigue syndrome (ME).

• The patient who recovered: spent a day making dinner for my daughter [ https://www.aftenposten.no/.../For-jeg-fikk-behandling
]

150 patients participated in the study. Half received placebo

- Could not let the patient get excited

- Patients who, after disclosure of the study were found to have received a placebo, received them in the study, indicating that we would try to get a new study with rituximab if rituximab proved to have a safe effect. When this was not the case, we could not let the patient group get out of bed for months and wait for the study to be published, says Olav Mella to Aftenposten

• New Network: Fresh ME patients gather

In order not to prevent the study from being published, he cannot provide further information about the results.

- But I said at the meeting that the study result means that rituximab, as we have said repeatedly before, should not be used at ME outside of approved clinical studies. We are still interested in immunotherapy of ME but will not use rituximab if a subset of patients can not be identified, for example, through a currently unknown biomarker.

The researchers continue

Olav Mella says that the research group is still engaged in ME and will continue with both patient-oriented research and research that reveals underlying disease mechanisms.

The study initiated in 2015 had 152 patients from five different hospitals to participate. These received either rituximab or placebo, first two infusions at two weeks intervals, then maintenance infusions after 3, 6, 9 and 12 months, and follow-up for 2 years.

The researchers hoped this study would provide a clear answer as to whether the cancer medicine works against ME. The study was national, randomized, double blind and placebo controlled.

Doctor Maria Gjerpe writes in a post on the blog Mariasmetode that it is terribly sad that one does not have a treatment that can help all the millions of sick patients around the world.

She got involved because RituxME was pre-approved from the Research Council, but research on ME was not given priority in the first round.

- Research on ME is underfunded. The study has cost a total of between NOK 20 and 30 million. As the results were promising from the first stages, there was great interest in researching to verify or falsify if Rituximab could have an impact on a larger patient group. "This probably does not", says Gjerpe.

She started a crowdfunding for the study. 5000 donors from more than 49 different countries managed to get 3.1 million research crowns in just over 90 days.

- It was a record. Far from enough money, but it made more balls start rolling and the study was eventually funded, with many different sources, she writes on the blog.
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https://www.aftenposten.no/norge/i/dd50mz/Nedslaende-forskningsresultat-for-ME-pasienter
 
Scarecrow said:
I wish this bit had not been included. We do seem to be getting a slightly mixed message.
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I think this is just because they haven't had a chance to fully analyse the results yet, or to discuss with Jo Cambridge, who's been working on B-cells since 2014 at UCL aiming to see if it's possible to be able to identify a subset of likely responders to rituximab, and I guess they're including the Cyclo-ME study as immunotherapy, and perhaps they're also thinking in terms of the wider groups they're cooperating with internationally.
 
Scarecrow said:
@Joel gif overload, that hurt. :arghh:

I don't understand the last one. Is it a quiz? Any prizes for the first to get it?
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I didn't really have words when I saw this news just reactions I can't actually play out in real life. The dinosaur riding a horse kicking a large football one at the end was just a bit of a "WTF, is this real life?" ending. Also it makes me chuckle. Spoilered below is a fuller video on youtube that it comes from for anyone interested.



Anyway, back on topic...on reflection, although this is not the news we hoped for it is still massively useful because we now know ME/CFS is unlikely to be an autoimmune disease and yet it is still likely there is immune dysfunction so it narrows things down.
 
I only heard about this today. It’s obviously disappointing, but I’ll tell you what — I’m incredibly proud of the response of people in the ME community, here and elsewhere. With this attitude, the disease doesn’t stand a chance. We’ll nail it.
 
Joel said:
Anyway, back on topic...on reflection, although this is not the news we hoped for it is still massively useful because we now know ME/CFS is unlikely to be an autoimmune disease and yet it is still likely there is immune dysfunction so it narrows things down.
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I agree. @Jonathan Edwards, this has the full quote of user @Joel's conclusion.
 
TrixieStix said:
Relapsing Polychondritis
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TrixieStix said:
symptoms that sounded very much like PEM.
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Should there be a new thread with people just posting conditions which are worse with exertion, or have a delayed fatigue? I’m thinking quite brief and to the point, with spin off threads if people are interested in discussing particular conditions.

Did I mention Periodic Paralysis in this thread? From what I’ve learnt about this I feel it must have some relevance to ME (or at least my experience ). It’s one of those things that’s broader than the name suggests.
 
Scarecrow said:
"We are still interested in immunotherapy of ME but will not use rituximab if a subset of patients can not be identified, for example, through a currently unknown biomarker." I wish this bit had not been included. We do seem to be getting a slightly mixed message.
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Yes, it is a little bit tantalizing isn't it... Like when you think the main agonist in a horror movie has been killed off, then they rise from apparent death to stumble about.

I suppose what he is saying, is that, despite the new primary endpoint data being unable to demonstrate an effect beyond placebo (so far as we can tell at this time, based on heresay), he, personally, still believes there is a subgroup who do genuinely respond to Rituximab. Perhaps due to the size of the positive effect and it's temporal association with the mechanics of B-cell depletion. However, more importantly, at this time, in terms of harm reduction, Rituximab cannot be recommended for ME/CFS diagnosed patients in general. Until, and unless, a biomarker for the Ritux subgroup can be found. This suggests that their data mining, so far, has been unable to identify a biomarker in the response group. Or, is he hinting that they're saving that bit for publication?!
 
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