Phase III Rituximab Trial - News

I am afraid Sasha is right on this. The trial is negative (I have had information via F&M). That means that the number of improvers was the same in both groups. The only legitimate conclusion is that there were no 'responders'. We have to assume that the apparent response at 6 months in phase 2 was a chance event.

Having watched events unfold over the last 3 years I had put the chance of a positive result from this trial at 40%. The jigsaw pieces were not fitting into place covincingly. It is a great credit to F &M that they did the critical trial. They have pursued this with spotless rigour and shown the way to the ME research community. But I do not think there is any reason to do further rituximab trials in ME. We need to follow other leads.

 

Where can I buy this placebo that has a 30% response rate?

EDIT: In fact, I think I'll buy three of them.

 

Straw no longer grasped.

 

Thank you for your frankness. If rtx is a dead-end, we should thank the researchers for looking at it with such care and rigour, and move on.

Any ideas what we should move on to, @Jonathan Edwards?

 

You need to go to Norway and you cannot buy them. The 'placebos' are Oystein Fluge and Olaf Mella. This is the great irony of dedicated scientific physicians. Their humility and honesty is likely to be a hugely powerful placebo. That is why you need properly controlled trials, however good a scientist you are.

If you had been in this study you would have had the 30%chance.

 

Were patients getting care/advice in the trial in addition to the rtx/placebo infusions?

 

Bear in mind that the patients' increased scores didn't necessarily mean that they were objectively better - only that they were rating themselves as better. That might indicate a shift in their way of thinking about their symptoms, rather than any change in the symptoms themselves.

This kind of thing in an open-label trial is why PACE is shit.

 

There are lots of things in the air. I would keep an eye on Baraniuk's brain studies, T cell conality and mitochondria.

 

So now I just need to find a couple of Fluge and Mella impersonators and hope for a placebo placebo effect.

Do you think it would help if I got one of my kids to wear a white coat and fall off a ladder?

 

Any sense of how far we are from diagnostic tools, treatments?

 

Anyone know how many patients were in the phase III trial?

In Fluge and Mella's doubled-blinded phase II trial (30 patients, 67% response rate) and their open label phase II trial (29 patients, 64% response rate), as well as the anecdotal report from Kolibri Medical clinic in Norway (which reports that rituximab treatment cures ⅓ of ME/CFS patients, makes an improvement in another ⅓, and has no effect in the final ⅓; ref: 1), you are getting around a 67% response rate.

Although in terms of anecdotal reports, these phase III negative finding are more in line with Dr Chia's comment:

 

@Jonathan Edwards Do you recall saying on PR that Jo Cambridge's team had identified an abnormality in B cells that looked like the opposite of autoimmunity?

You weren't able to tell us more at the time but did anything ever come of that?

 

@Jonathan Edwards - are you able to say what this means for the work at UCL?

 

152?

 

Yep, 152.
https://clinicaltrials.gov/ct2/show/NCT02229942

 

From an objective point of view it couldn't hurt, you.

 

Whoop whoop! If true - great news. I always thought there would be a third who might respond.

Do please Jorgen Jelsted's Blog post about it. He talks about low response rates in Lupus studies, a disease known to involve B cells. It didnt turn out to be the hoped for treatment in Lupus at all. So, it doesnt mean something serious isnt going on, or that we dont have autoimmune issues. It will be interesting to see what they did learn from the study...

 

These are, are they not Dr Edwards, areas of research? Are any meds/ treatments being looked at?
RTX disappointment is huge, as you know, because folks and younger people thought, I'll scrimp my pennies together and get the RTX and get my life back.

 

But there was no difference between the rtx and placebo groups in terms of the number of people who rated themselves better enough to be classed as 'responders'. That is, no one was 'responding' to anything.

 

People must stay positive....think of the party you'll be able to throw with all that money now it's not needed for rtx.......it's a lot of money, what a party, the food, the fine beer/ales/wine, the people, the live music.....

erm.........maybe not

dry rice cracker anyone?