Phase III Rituximab Trial - News

[Jenny TipsforME]

@Kalliope 20 years for me this winter. And it was the first thing that seemed plausible to me too

I’m in the process of getting my whole genome analysis. Might pin my provisional hopes of a healthy future on ME being a misdiagnosis and having something treatable instead

 

[Gingergrrl]

We always suspected that ME/CFS comprised several diseases.

I absolutely believe this as well.

Wasn't the dosages of Rituximab in the phase III trial a tad smaller than in the previous ones?

From one of the posts above, it looks like the patients in the study received 500 mg of Ritux (regardless of BSA formula used in autoimmune dosing) and this seems like a low dose to me. It is lower than what I received and I am a relatively small person. I am not saying a higher dose would have changed the results but it is interesting to me.

 

[dannybex]

I'm not sure if this question has been asked and answered, but I thought there was a gag order or some such restriction against talking about the study until it is published next spring.

???

 

[TigerLilea]

That made me cry. I am so depressed from this terrible outcome.

I'm actually not surprised by the outcome. I had read that at least some of the responders got worse again once they stopped taking Rituximab.

 

[Gingergrrl]

I'm not sure if this question has been asked and answered, but I thought there was a gag order or some such restriction against talking about the study until it is published next spring.

???

I thought that too and am kind of surprised but I know nothing about how these studies work!

 

[Barry]

Overall, I'm grateful to Fluge and Mella's honesty. They've never tried to spin their results. I hope they'll keep researching ME.

Exactly. They've clearly identified that way out of the maze is blocked, and saved any further resources being diverted in that direction. Good scientists doing good science - identifying blind alleys is part and parcel of finding the right path.

If only the PACE authors had been the same, let alone those who still divert and waste resources down alleys most people recognise to be dead ends.

 

[Pibee]

I had read that at least some of the responders got worse again once they stopped taking Rituximab.

I don't think this would affect outcome , it is expected to get worse when stopped. It still counts as success

 

[BurnA]

It's bizarre the way the first phase II trial had responders who relapsed shortly afterwards. And then in the second (unblinded) phase II the response duration increased after the maintenance doses.
So there was a link between dose and duration of response. Hard to believe it wasn't a genuine response.

Perhaps the patient pool in the phase II trials wasn't broad enough.
Best to wait for the results to be published now.

 

[Trish]

I'm not sure if this question has been asked and answered, but I thought there was a gag order or some such restriction against talking about the study until it is published next spring.

???

I think that was a self imposed gag by the researchers. I guess they were hoping for a positive outcome, so thought they would have the best chance of a big publication and publicity splash once they got their paper published. I guess having found out the disappointing news once they unblinded the data and analysed it, they thought wasn't fair to patients to leave us hoping for another 6 months.

 

[Simone]

This was not news I had anticipated waking up to! I feel so deflated.

I am so grateful to Fluge & Mella for their dedication to good science, and the work they have already to contributed to this field. I'm also feeling despondent. I think many of us have been holding our breath for the results of the Phase III trial, not necessarily in the hope of a cure, but perhaps in the hope of some treatment in the near future, and of legitimacy (the deconditioning hypothesis would have been very difficult to reconcile with successful treatment with a monoclonal antibody!).

Alas! One again, we must wait! But how long for?

Science is just too slow.

 

[Kalliope]

And so it begins..
I notice likes from both Michael Sharpe and the LP-coach Live Landmark

 

[Kalliope]

Author and journalist Jørgen Jelstad with a blog post today about the news. He has written a book about ME and held a pre-conference dinner speech for Invest in ME a few years ago.

ME-studien på rituximab er negativ

Google translation: The ME Study on Rituximab is negative

In such moments it is important to hold on to the big picture - much more is happening within ME research now than ever before in history - and it will lead to more knowledge and better treatment. I know it is a very poor comfort, but the hope is that after all it is a kind of comfort for patients who have lived for a number of decades where nobody has cared much about them. Now it's actually more and more that really care.

Edit to add:
I led a panel discussion with the researchers at the conference at Rikshospitalet today, and Olav Mella was clear that they wanted to continue the ME research. They do not plan to quit. They also have a host of other exciting findings from the research associated with the major rituximab study, and these will contribute to new and important knowledge in the ME field as they complete the analyzes and publish. The question is of course if they receive funding to continue further studies in the coming years.

 

[TiredSam]

I hope that all the private doctors who were ready to take thousands from ME sufferers in exchange for rituximab, despite being asked by Fluge and Mella not to, will reflect upon their actions. I don't really expect them to, or or offer any refunds.

Peter White and co. don't have much to smile about these days, so they'll be making the most of this, and making fools of themselves acting as if the rituximab result makes any of their ridiculous psychosocial nonsense more likely to be true (spot the logical error there if you can), and as if their theories ever managed to stand up to a trial one tenth as rigorous. There will probably be a vomit-inducing SMC release (they've been rather quiet lately).

But they're finished and the science will continue.

 

[Ysabelle-S]

I haven't been hit by this the way others have. Maybe I didn't have high expectations or it was an 'I'll believe it when I see it' mentality, however on the subject of the SMC, they've been getting a lot of stick on George Monbiot's account recently. I'm sure you've probably had posts on this around here somewhere. What a pathetic shoddy little outfit they are.

Fluge and Mella have done a lot of work for this patient community, and they've still achieved more than White, Wessely and co, all of whom are failures in this field.

 

[Hutan]

I know the following comment falls into the 'clutching at straws' category, but I wonder about the quality of the rituximab used. See for example this thread that reported that some samples of rituximab had no active ingredient - albeit from quite a long time ago.

https://www.s4me.info/index.php?threads/false-rituximab-samples.1066/#post-18328

I expect that the rituximab used by Fluge and Mella was quality checked and stored appropriately. I hope that they can comment on that when they eventually publish on the study.

 

[hinterland]

Yes, you're right. The follow up doses were fixed at 500mg, rather than being 500mg/m2 up to a maximum of 1000mg. Also the maintenance period was 'stretched out' slightly.

Phase II 'Materials and Methods
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129898


Phase III protocol
https://clinicaltrials.gov/ct2/show/NCT02229942

Thanks for confirming that, but unfortunately I think this is clutching at straws. As the authors said, it was a well conducted study of b-cell depletion; they would have been able to measure and monitor levels of b-cells to confirm the Rituximab was technically effective. It did it’s job. Only, the b-cell depletion didn’t bring about the desired improvement in patient’s symptom scores and health outcome data.

 

[Scarecrow]

Thanks for confirming that, but unfortunately I think this is clutching at straws. As the authors said, it was a well conducted study of b-cell depletion; they would have been able to measure and monitor levels if b-cells to confirm the Rituximab was technically effective. It did it’s job. Only, the b-cell depletion didn’t bring about the desired improvement in patient’s symptom scores and health outcome data

I was just noting the differences in response to a question!

 

[Adrian]

It will still be interesting to see their results and they seem to have done a lot of blood analysis along the way,

I'm wondering if they had no real improvements or good improvements in the placebo group.

 

[AndyPandy]

Disappointing news.

I looked at my 23andme results a few weeks ago. I can't remember which company I used to generate the "health report" and I'm not able to check this on my desktop computer right now.

Anyway I'm pretty sure that the list of drugs in the report included Rituximab. I'm pretty sure it indicated that I wouldn't do well on it based on my genes. This would have been based on the uses for Rituximab back then. I had the testing done and report generated around 2013.

I'm not in a position to check this information for a while but thought I'd mention it in the context of the trial results. I was left with the impression that Rituximab probably wasn't for me in terms of treating ME anyway.

Best wishes Andy

 

[Sunshine3]

Everything is not lost....we will stick together and try to keep fighting the good fight. It's a setback but we will get over it. As Carol Head from Solve always says 'Onward'.