Phase III Rituximab Trial - News

[Scarecrow]

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 association with 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

That's exactly how I interpreted the original announcement via Marky90.

Or, is he hinting that they're saving that bit for publication?!

Here's hoping but perhaps a bit too much to expect.

 

[Woolie]

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.

Yes, I'm a bit taken aback by the posts above describing PEM as an energy shutdown, because its nothing like that for me. The experience after exertion is more like I've stirred up a hornet's nest of nasty fluey sickness, aching and soreness.

I'm weird, and don't think I'm a typical case at all. But it just goes to show PEM may be many things to many people.

 

[Woolie]

I think it is important on a forum that is aimed at helping and educating patients that any claims that a particular treatment made us better or worse are done carefully, with the caveat that we can't know whether it was chance variation, part of the natural course of our illness, or a direct effect of that treatment, we can only report the correlation, not the causation.

Presumably, when Fluge and Mella analyse their adverse effects data, they'll be able to tell us if there's any evidence for a subgroup getting worse on ritux. It seems to me its entirely possible, given that ritux is an immune suppressor.

 

[AliceLily]

Yes, I'm a bit taken aback by the posts above describing PEM as an energy shutdown, because its nothing like that for me.

I wonder if it is neuro-immune induced weakness that some of us are feeling as well.

When my ME is severe, or I have accumulated too many "over-doings" over a period of time I experience as part of the PEM experience 'what feels like' a neuro-immune weakness. I barely can look after myself because of the weakness. It feels like a energy shutdown due to the weakness. I can't explain it any better right now. The weakness is dense and it makes one feel very fragile, 120 years old.

I get the flu-like symptoms as well with PEM. The summer months not so bad.

 

[zzz]

Admin edit: Off topic text discussing adverse effects of Rituximab has been moved to this post in a new thread - https://www.s4me.info/index.php?thr...adverse-effects-of-rituximab.1242/#post-20907

I wonder if it is neuro-immune induced weakness that some of us are feeling as well.

I'm sure it is. The ICC definition for ME replaces "PEM" with "PENE" - postexertional neuroimmune exhaustion. As soon as I heard that term, I thought, "Yeah, that's it!" In the ICC, it is the only symptom that is compulsory in order to be diagnosed with ME.

 

[AliceLily]

I'm sure it is. The ICC definition for ME replaces "PEM" with "PENE" - postexertional neuroimmune exhaustion. As soon as I heard that term, I thought, "Yeah, that's it!" In the ICC, it is the only symptom that is compulsory in order to be diagnosed with ME.

Thanks for mentioning this @zzz I must read through the ICC definition again and refresh my memory. Good to see ICC has this 'Pene'.

I hope they describe a weakness + exhaustion but I will check if they do. The weakness part should also be in the description.

 

[Kalliope]

Yes, I'm a bit taken aback by the posts above describing PEM as an energy shutdown, because its nothing like that for me. The experience after exertion is more like I've stirred up a hornet's nest of nasty fluey sickness, aching and soreness.

I'm weird, and don't think I'm a typical case at all. But it just goes to show PEM may be many things to many people.

Yes, same here. I experience it as a flare-up of symptoms. Also, for me, a crash is an extreme version of PEM, but I see others use crash and PEM as the same thing. It is a bit confusing..

---

By the way, thought you guys should see this tweet from Wesseley about RituxME as a response to Henrik Vogt's gloating tweets a couple of days ago.

 

[TiredSam]

Wessely is trying to stop his followers gloating because he's finally realised how counter-productive it is, having ended up with egg on his face every time he's opened his mouth recently. Anything else he or the SMC said would only lead to them being taken apart and made to look as stupid as they are yet again. SMC silent, Wessely careful not to gloat. Who'd have thought that even they would be capable of reviewing their disastrous PR gaffs of late?

Simon Wessely starting a sentence with "No one should mock ...", I've lost count of the amount of times that guy has broken my irony meter. Will he be applying his newfound wisdom "One result rarely settles anything" to the PACE trial?

 

[TiredSam]

Wessely's weasel-words from 2015:

“There is now a strong case to be made for a larger trial,” says Simon Wessely of King’s College London, who has treated people using cognitive behavioural therapy. “The belief that [CFS] is all in the mind has been around since the beginning,” he says. “It’s tragic that it might take a study like this to take sufferers seriously.”

For someone whose ship is such a thing of beauty, he seems remarkably keen to be prepared to jump off it when the time comes.

 

[Valentijn]

For someone whose ship is such a thing of beauty, he seems remarkably keen to be prepared to jump off it when the time comes.

It was a bit odd that he he seemed to be happily sailing along with the rest of the crew for so long after saying "bon voyage" to ME/CFS. Now I realize he'd merely relocated from the captain's seat to an unlaunched life boat to prepare for the inevitable

 

[Skycloud]

SW has his ducks in a row for a happy future. I wouldn't be surprised if from his perspective he can afford to loosen his grip on PACE; his position in the establishment is secure, his image well protected. I expect his income is too.

He's not always right though, is he.

 

[Prairieplant]

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

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

This was a wonderful translation by Anna Mitchell, making it clear to me where this trial stands, as clear as it can be until the paper is published. I wanted to read what was at the second link quoted from her post about the patient who recovered & spent the day making dinner, but it does not work, says the item is not found at aftenposten.no. I figured I could put it through google translate once the right url is available. Thanks!

 

[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.

Apparently this was NOT said after all. No numbers were given, according to another attendee.
Guess we'll have to wait for the publication.

 

[Cheshire]

ME Association Statement: Negative phase III clinical trial result from Norway for Rituximab in ME/CFS

“We also know that the physicians involved in this research – Drs Oystein Fluge and Olav Mella from the Haukeland University Hospital in Norway – have taken great care in the way that they have devised the protocols for the clinical trials that have been carried out and reported.

“Despite the headline negative finding, we believe that this trial will still provide useful insights and contribute to a better understanding of M.E., and we also have the results from the Cyclophosphamide clinical trial to look forward to. We are very pleased that this knowledgeable, and valued, research team will continue with their work, trying to find answers to the M.E. puzzle.

http://www.meassociation.org.uk/201...rway-for-rituximab-in-mecfs-27-november-2017/

 

[Awol]

I wanted to read what was at the second link quoted from her post about the patient who recovered & spent the day making dinner, but it does not work, says the item is not found at aftenposten.no. I figured I could put it through google translate once the right url is available. Thanks!

Thank you @Prairieplant The link doesn't work as it is a copy-and-paste of an insert in the main article, and I don't know what the full link is, but these are the articles on Aftenposten tagged as ME: https://www.aftenposten.no/tag/ME

 

[Kalliope]

One of the biggest newspapers in Denmark, Politiken, writes about RituxME and the negative results

Håb brister for kronisk trætte patienter: Kræftmedicin hjælper ikke
Google translation: Hope fails for chronically tired patients: Cancer medicine does not help

The article also contains a bit on the ME-debate in Denmark and it mentions the IOM-report.

The sick no longer wish that the disorder, as is the case in Denmark, should primarily be remedied by cognitive behavioral therapy and so-called graduated training, in which the sick person should slowly have sustained his physical ability. Especially in England, for a couple of years, there has been a violent showdown with the psycho-somatic approach to suffering, which we also use in Denmark.

Edit to add tweet about the article from the journalist, if anyone wants to "like" or retweet or engage otherwise. He participated on the Europe-premiere of Unrest in Copenhagen and has written a few decent articles on ME. One where Norwegian experts were criticising Denmark for defining ME as psycho-somatic.

 

[Esther12]

One of the biggest newspapers in Denmark, Politiken, writes about RituxME and the negative results

Håb brister for kronisk trætte patienter: Kræftmedicin hjælper ikke
Google translation: Hope fails for chronically tired patients: Cancer medicine does not help

I thought that this bit really reflected the Fink spin on things, but other than that it's not too bad.

In Denmark, chronic fatigue syndrome / ME falls under the category of functional disorders.

It generates a lot of patients severely, as functional disorder is characterized by an unexplained condition in which both the psyche and the body are important for disease. However, patients with chronic fatigue syndrome and patient associations at home and abroad have for several years been fighting for the disorder to be considered a pure biological disease - even though no physician can yet diagnose the disorder from objective tests.

 

[Kalliope]

I thought that this bit really reflected the Fink spin on things, but other than that it's not too bad.

Yes, it isn't perfect, but considering it is from Denmark, this isn't bad.

 

[Inara]

Sounds not so good to me...
"The sick no longer wish...[CBT, GET]" (sounds like patients are little children who should get reasonable at last)
"Tired patients..."

My opinion may be unjust, then I excuse.

 

[Andy]

Comment from Charles Shepherd

“I was disappointed to learn – while at the Royal Society screening of the documentary, Unrest, in London last Thursday – of the preliminary (but unpublished) results from the phase III clinical trial of Rituximab, that has been carried out in Norway.

“This large, multicentre, ‘gold standard’ clinical trial, involved 152 people with ME/CFS receiving either Rituximab or a placebo, with initial treatment followed by maintenance treatments at 3, 6, 9 and 12 months, and a two year follow up.

“The ME Association has consistently taken the position that Rituximab could be one of the most promising developments in the search for a safe and effective drug treatment that is targeted at the underlying disease process in ME/CFS.

“We also know that the physicians involved in this research – Drs Oystein Fluge and Olav Mella from the Haukeland University Hospital in Norway – have taken great care in the way that they have devised the protocols for the clinical trials that have been carried out and reported.

“Despite the headline negative finding, we believe that this trial will still provide useful insights and contribute to a better understanding of M.E., and we also have the results from the Cyclophosphamide clinical trial to look forward to. We are very pleased that this knowledgeable, and valued, research team will continue with their work, trying to find answers to the M.E. puzzle.

http://www.meassociation.org.uk/201...rway-for-rituximab-in-mecfs-27-november-2017/