RITUXME phase III study--flow mediated dilation

Hi,

From the other forum, Marky posted the text below about the phase III study from an F&M slide from their recent presentation. Does @Jonathan Edwards or anyone knows what this means? Where these difference between RTX treated patients and controls or baseline measurements?

Also I wanted to try to parse @Jonathan Edwards thoughts on the Phase III study--these are found in some other threads but I wanted to try to summarize in place if possible--also with the caveat that the study is not yet published.

1. There is no indication that rituximab is a useful treatment for CFS/ME
2. Earlier positive responses to rituximab were likely due to a placebo effect (2015 study) or maybe due to not a large enough sample (2011 study)
3. There is currently no indication that there are "subgroups" that would respond to rituximab

But if information posted below indicated that there was a decrease in flow mediated dilation, then maybe there is some benefit of rituximab for CFS?

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Some good news though...
A slide showed they found p-001 decreases in flow mediated dilation in both RITUXME-baseline patients and pilot patients, and also a prolonged systemic hyperemia response after a POHR-test (http://www.perimed-instruments.com/post-occlusive-reactive-hyperemia)

They ask why? This is normally seen in patients with severe hypertension. Is the NO-production compromised? And by what? Autoantibodies? (which still is possible, there are other autoantibody-producing cells, and it might be going on in tissue too). Other negative bloodflow-regulators in bloodstream? And how does these findings relate with exercise or brain activity, e.g. reading).

Findings yet to be published..

View attachment 25178

 

Endothelial function was one of the objective outcome measures in the RituxME trial. It was tested at baseline and then several times after Rituximab or the placebo was given. Mella talked about it during his Invest in ME presentation (available on DVD).
Endothelial function in ME/CFS is listed as "substudy" on the RituxME website: https://helse-bergen.no/en/avdeling...sinsk-fysikk/research-and-development/rituxme

 

I reckon there was a diagnostic criteria problem or the like with this study.

I’ll bet there were people with chronic fatigue rather than ME/CFS

 

I think it is hard to think that is the case. The diagnostic criteria used were, as far as I know, the same as for the study (by the same group) that suggested that rituximab might have a beneficial effect. So we would have to argue that that study told us nothing either. Which would mean there is no reason to be surprised that it had no effect in the second study.

 

No, they used Canadian Consensus Criteria - http://me-pedia.org/wiki/Canadian_Consensus_Criteria

Source: https://clinicaltrials.gov/ct2/show/NCT02229942