Phase III Rituximab Trial - News

BurnA said:
I think the key information we are missing is the placebo response rate.

The 30% response rate suggested in the ritux arm is also meaningless until we know placebo response rate. If that is also 30% then...
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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.
 
TiredSam said:
Where can I buy this placebo that has a 30% response rate?
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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.
 
Jonathan Edwards said:
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.
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Were patients getting care/advice in the trial in addition to the rtx/placebo infusions?
 
TiredSam said:
Where can I buy this placebo that has a 30% response rate?

EDIT: In fact, I think I'll buy three of them.
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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.
 
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:
[Dr Chia] believes the positive response to RTX in Norway is due to regional homogeneous genetics, and that he has not heard good results from his American patients who have tried RTX.
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Kalliope said:
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.
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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...
 
Jonathan Edwards said:
There are lots of things in the air. I would keep an eye on Baraniuk's brain studies, T cell conality and mitochondria.
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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.
 
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?
 
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