Rituximab Phase III - Negative result

Marky90

Marky90

Science breeds knowledge, opinion breeds ignorance
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Hey everyone,
I know this is tough news, but it is what it is..

It became known today that rituximab failed to be clinically effective in the treatment of ME/CFS.
This was confirmed in a letter to the participants from Fluge & Mella.

They emphasized that regardless of the negative result, they now have good data, which will be analyzed for publication in a proper medical journal, and they did not rule out future clinical studies either.

Today they are having a presentation in Oslo. It is being videotaped, so maybe more will be said when that surface.

Updates from Oslo (PS: by word of mouth):

- Cyclo-study looking "positive", but larger studies
problematic due to side effects.
- They don`t know if they will study Rituximab more, if they would they probably have to identify the subgroup.
- Didn`t say more then that the rituximab-study was negative.
 
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Scarecrow

Scarecrow

Revolting Peasant
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Marky90 said:
- They don`t know if they will study Rituximab more, if they would they probably have to identify the subgroup.
Click to expand...
Overall, such disappointing news but there does seem to be a suggestion that it's effective in a minority group. And if that's true, it's still something positive to take from the trials. Fingers crossed that UCL can elucidate what's going on.
 
Marky90

Marky90

Science breeds knowledge, opinion breeds ignorance
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MartinDH said:
Tough!

Maybe identifying the subgroups is much more important than I thought. Because: I don't think that a total remission in CFS due to RTX treatment (which occurred in Phase II) can be placebo.

Or they really messed up diagnostic criteria ;-)
Click to expand...
It`s anyone's guess.. Maybe the use of activity trackers played a role
 
BS3boy

BS3boy

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I really think they need to subgroup seriously for this sort of thing, and do that with a rigorous battery of tests & also detailed interviews on illness history, and illness pathway patterns, for the trial participants. Maybe even using genetic information. Otherwise, you get a homogenous group of people with general symptoms that come under the CFS umbrella, and it's hardly surprising that a drug is shown to not work on all of them .

Sad news , and I worry the BPS bridage will be feeling a little more smug that yet more targeted bio / drug research has, apparently, failed to produce a positive result for us.
 
Martin aka paused||M.E.

Martin aka paused||M.E.

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perrier said:
It's just awful news, just so drenching, so demoralizing.
But now more and more I'm starting to wonder maybe folks don't all have the same illness at all.
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That would be bad news. Because if they find sth. for one group..........
But I think that the underlying cause has to be the same since Dr. Davis nano-chip seems to work on all CFS patients...
 
Simon

Simon

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Well, it’s certainly disappointing news.

But I think we should all be grateful to Fluge and Mella for their excellent work, from following up promising chance findings in the clinic, to the first pilots trial and small study and then to organising a large clinical trial. Then for acknowledging a negative result for what it is, rather than trying to spin it as something different.

Good science looks like this.

I hope they will continue their work in the field.
 
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