Phase III Rituximab Trial - News

I saw now the reason for it. Dr. Scheibenbogen said in a video taped talk last summer, the dosing of Rituximab had to be halved compared to the more success trial, due to financial reasons.

 

This still seems unlikely?

 

It seems unlikely that they'd fundamentally change the treatment for their follow-up trial. Maybe there was just some misunderstanding about what actually happened?

 

If THAT is true...

 

That's not true, it's some sort of misunderstanding that seems to be turning into a "truth" - been mentioned before in this thread from other sources.

It was a bit nerve-wrecking before the study got funded, but they got enough money in the end. Patients did a campain and started collecting a pretty big sum, that also got the public attention on the trial. Kavli Trustfund got involved and supported the trial, and finally they got a direct sum via the national budget (something that never happens). Also their hospital covered the cost for Fluge and Mellas time.

It is true, that there was an adjusting of size of doses, number of doses and the intervall between them. But this was based on the observations from the first pilot study, that responders seemed to take longer to get an effect than what is usual in other conditions treated with rituximab. They then did a study to check if this observation held up before planning the larger multicenter study.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4488509/

That second study seemed to confirm that, so that informed their decisions for the larger study. Of course, that also made the overall study a bit cheaper (?) - edit: not sure on this bit actually (cheaper?), and don't have the brains to double check now - and they were abel to start the study sooner instead of waiting for more funding. But that is not the same as to say the desicion was based on not having enough money.

Is this talk online somewhere? There have been a lot of rumours about why the study failed from patients, but if doctors are also making these statements, then perhaps it is something Fluge/Mella should adress.

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Paging @Kalliope and @andypants, as you are the other norwegians I have noticed here - please do correct me, of my recollection of events is inaccurate?

 

This is a misunderstanding. The dose was not halved. Rituximab dosage is probably not very critical anyway.

 

I do not know if what Dr. Scheibenbogen said is the truth or a misunderstanding. It is just what she said in a recorded video talk and probably the source of the rumor. I have seen this video yesterday for the first time. As long as I know it is not on YouTube or something similar.

 

As far as I know, you are right @inox

The 200 people who got treatment privately used the regiment from the phase II study and I think the success rate in the end turned out to be similar to the phase III study, very few people saw actual or lasting improvement.

There are of course no official data on this, but like with everything else we would have heard if 60-120 of those people were suddenly better. Of the 150 in the fb group I was in, only 4 or 5 still count themselves as significantly improved. We were not that surprised when the study came out.

 

I'm glad you shared @cyclamen , it's good to know what is beeing said, and I guess these sort of misunderstandings will be cleared up when the study is published and can be referenced.

Also, it gave me a chance to get to know a bit of Dr. Scheibenbogen work, she was a new name to me. She seems knowledgable, working on immune findings, Ramsay award winner, leader of the EUROMENE's group for working on a biomarker etc.

https://me-pedia.org/wiki/Carmen_Scheibenbogen

 

Where did you see the video? I'd like to watch it.

 

Good morning, it is on this DVD:
https://www.fatigatio.de/shop/?tx_browser_pi1[showUid]=70&cHash=55cc5dbd22

 

Thanks!

 

I lost track of the updates on the Phase III trial results.

Did the investigators publish the results yet?

I could only find this paper:

1. Rituximab Serum Concentrations and Anti-Rituximab Antibodies During B-Cell Depletion Therapy for Myalgic Encephalopathy/Chronic Fatigue Syndrome
   Rekeland, Ingrid G. et al.
   Clinical Therapeutics (in press), published online: November 28, 2018

https://www.s4me.info/threads/clini...therapy-for-cfs-me-rekeland-mella-et-al.6971/

In the abstract, they write ("Implications"):
"Clinical improvement of patients with ME/CFS in the KTS-2-2010 trial was not related to rituximab serum concentrations or ADAs [antidrug antibodies]. This finding is also in line with a recent randomized trial questioning the efficacy of rituximab in ME/CFS."
But also:
"Rituximab concentrations and ADAs still offer supplemental information when interpreting the results of these trials."

Among the references, I can't find a paper on the "recent randomized trial questioning the efficacy of rituximab in ME/CFS", though.

Edit: Found the reference. It's not a paper on the trial, but the Nature article by Amy Maxmen (Jan 2018)

 

Not published yet.

 

Thanks, @andypants !