Rituximab Phase III - Negative result

[Cinders66]

This is sad news, some will really struggle with this news.

I personally as severe wasn't expecting the drug to help me as this was something already suggested but we all hoped it would be the game changer and get at least some part of the puzzle fixed.

What is the threshold for a negative result,
I suppose it could still be helping some but 25 % wouldn't be enough?

With what people think on subgroups maybe it's too much to expect a large percentage to improve with it.

Utter blow though, the main treatment hope and a lot of money. I gave a lot to the trial. I don't regret it but now the mountain seems higher to climb.

Thank heavens for the new research on energy coming through which, if it gets more funding for large trials can hopefully take off.

Much thanks to the courage , commitment and honesty from Drs Fluge and Mella and I too hope they continue working in the field. Their metabolism research has been very important too. They must feel disappointed but we are so grateful they took on something few others would have.

 

[MEMum]

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.

From Prof Mella's talk in the summer at IiME (hope I got the right name) he seemed committed to keep trying with different meds. His comment, if I remember correctly was "It would be surprising if the first one or two immune modulators we tried are the ones that end up being the best for ME treatment". He certainly sounded optimistic (for a Norwegian! Don't get me wrong he's a lovely approachable guy as well as all his medical/research skills, but his manner is calm and composed.)

I think that with all their substudies and evaluation of baseline data etc there will be some very useful information for researchers to work on, and fit more pieces into the puzzle that is ME

 

[ukxmrv]

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.

I can feel a "thank you" card coming on. At the moment I need to sit in a corner and weep but a card will definitely be forthcoming in the future.

 

[Nickster]

This is so disappointing. I know this is how science works and we have to look at the truth of what can be used as treatments.

I am so glad that we have many different scientists, doctors and patients trying to find the correct treatments. Glad that we have awareness to this disease and funding.

Ron Davis talked about clinical trials for trying drugs and maybe that will be the golden ticket. He certainly knows a lot about this disease.

 

[Scarecrow]

@deleder2k I don't know if it's still not ok for you to comment on your own response until publication but I just want to say that I hope so much that you got a positive result.

 

[Ben H]

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.

I can't say how sad I am at this initial news, but unfortunately that's good science. My heart is breaking for the wider impact of this but this is what good science does and Fluge and Mella have been extraordinary scientists and I am so grateful for what they have done and continue to do. Would like to see P values etc but , damn damn damn.

EDIT: On a positive note perhaps F and M have elucidated some findings that are important through this research such as PDH, PDK1 etc.....it may still come to fruition.


B

 

[Tally]

As disappointing as this is, there are many positives in this.

We got excellent, honest reserchers in Dr. Fluge and Mella interested in our illness. They collected a lot of important data, started a biobank, are continuing research with different drug etc.

They may still be able to identify subgroups or show that there are no subgroups and that indeed something like Suramin might help us all.

One way or another, we have learned something more about our illness.

 

[deleder2k]

@deleder2k I don't know if it's still not ok for you to comment on your own response until publication but I just want to say that I hope so much that you got a positive result.

Thanks. Non responder. No effect whatsoever. Perhaps I should change my profile picture? To be honest I think that some patients that participated in the study got worse. It is very tough to go back and forth to the hospital. Some had to catch a flight to do it. Lets hope that most patients didn't get permanently worse. It will be interesting to read the study when its published.

Think about where we would be without this research. Many researchers has gotten interested in the field partly due to this research. Another thing is that they see FMD dysfunction as Newton do. We should also remember the interesting PDH research.

 

[Martin aka paused||M.E.]

Thanks. Non responder. No effect whatsoever. Perhaps I should change my profile picture? To be honest I think that some patients that participated in the study got worse. It is very tough to go back and forth to the hospital. Some had to catch a flight to do it. Lets hope that most patients didn't get permanently worse. It will be interesting to read the study when its published.

There is a German doc in Munich who is treating a CFS-patient that got much worse under Rituximab. He is completely disabled due to only one injection. I don't know if he has ever recovered... But I think he did not!

 

[Scarecrow]

Thanks. Non responder. No effect whatsoever.

I'm so sorry.

Think about where we would be without this research. Many researchers has gotten interested in the field partly due to this research. Another thing is that they see FMD dysfunction as Newton do. We should also remember the interesting PDH research.

Absolutely.

I think the common themes in everyone's reactions, despite our disappointment, are gratitude to Fluge and Mella and taking consolation from what they have managed to achieve so far. They have definitely given hope for the future.

they see FMD dysfunction as Newton do

In case anyone is thinking Julia Newton in Newcastle, this is a reference to DJ Newton in Dundee (I am assuming).

 

[Sasha]

Really sorry to hear that, @deleder2k.

 

[Nickster]

Thanks. Non responder. No effect whatsoever. Perhaps I should change my profile picture? To be honest I think that some patients that participated in the study got worse. It is very tough to go back and forth to the hospital. Some had to catch a flight to do it. Lets hope that most patients didn't get permanently worse. It will be interesting to read the study when its published.

Think about where we would be without this research. Many researchers has gotten interested in the field partly due to this research. Another thing is that they see FMD dysfunction as Newton do. We should also remember the interesting PDH research.

I thank you for trying and being a soldier in this disease. Sorry it did not work. That's hard.

Have you heard how the trial is for the cyclo study?

 

[Kati]

Thank you for sharing this news, despite it being a negative study.

I would also like to thank the research subjects who submitted to either receiving the drug or the placebo. I would like to thank Drs Fluge and Mella for giving it a try. I hope they will continue researching us. Only through clinical trials and competent research will we know what will work and what doesn’t work. And as someone mentioned above, we definitly needs objective measures in order to move forward in the science of ME to measure recovery. I am looking forward to read the papers.

Perhaps it would be a good day to make a donation to your favorite researchers.

We cannot go backwards.

 

[TenuousGrip]

Well ... that's definitely a serious sack of Seconal.

But I'm going to do what I've (and I'd guess many others) become so much better at than I once was: I'm going to grieve this as yet another loss, and then go back to living day by day, hour by hour, minute by minute, and second by second.

Yes. Failures teach science almost as much as successes. I will try to remind myself of this.

 

[alex3619]

But I think we should all be grateful to Fluge and Mella for their excellent work

Yes. They explored a very important possibility, and got a result. They also have not stopped yet, though Rituximab looks like being a dead end for now. This is how science is supposed to work. Disappointing results are still a part of the scientific record.

 

[HowToEscape?]

That's very very sad news....

Well conducted research is never bad news. What’s bad news is sloppily conducted research, research that doesn’t distinguish our disease from some other chronic disease such as depression, Or some form of go buzz off disguised as research. Yeah it would’ve been much better if this turned out to be a widely applicable treatment, but reliable data of any kind is valuable.
You probably know the quip from Edison who said he had discovered 997 ways not to invent the lightbulb. That’s how discovery works, except the Publis city afterwards doesn’t mention the 10 years of trying before the 10 seconds of triumph.

 

[Hip]

Odd how this Fluge and Mella phase III trial failed to find any positive effect, yet Kolibri Medical clinic in Norway reported that rituximab treatment cures ⅓ of ME/CFS patients, makes an improvement in another ⅓ of patients, and has no effect in the final ⅓ of patients. Ref: 1

This Kolibri's results are consistent with the phase II study, which found 60% of patients made a major improvement.



Although these phase III negative finding are more in line with Dr Chia's comment:

he [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.

 

[Seven7]

I expected at least to see the 30% of autoimmune as positive results. This is very bizarre disappointing and unexpected, I feel as if my Puppy died.

 

[Martin aka paused||M.E.]

Odd how this Fluge and Mella phase III trial failed to find any positive effect, yet Kolibri Medical clinic in Norway reported that rituximab treatment cures ⅓ of ME/CFS patients, makes an improvement in another ⅓ of patients, and has no effect in the final ⅓ of patients. Ref: 1

This Kolibri's results are consistent with the phase II study, which found 60% of patients made a major improvement.

I think it's all about identifying the subgroups. But as a first step one has to find a general biomarker. Then, maybe, everything and the failure of this Phase III study will make sense...

I am excited what the echo will be. Hopefully it's no wind in the sails of the CBT community...

 

[Ben H]

I think it's all about identifying the subgroups. But as a first step one has to find a general biomarker. Then, maybe, everything and the failure of this Phase III study will make sense...

I am excited what the echo will be. Hopefully it's no wind in the sails of the CBT community...

Yep, we need a biomarker.

And the sails of the CBT crew have so many holes in them, they could only dream of conducting such thorough, rigourous research. Let alone understanding it...

But im pretty sure we will get a 'This is why Phase III trials are so important' from them (despite not adhering to that themselves ofcourse, or accepting null results, or managing to design a study without a plethora of flaws etc etc).


B