The 12th Invest in ME Research Conference June, 2017, Part 2
MEMum presents the second article in a series of three about the recent 12th Invest In ME International Conference (IIMEC12) in London.
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Rituximab Phase III - Negative result

Discussion in 'Latest ME/CFS Research' started by Marky90, Nov 21, 2017.

  1. Marky90

    Marky90 Science breeds knowledge, opinion breeds ignorance

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    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.
     
    Last edited: Nov 21, 2017
  2. shannah

    shannah Senior Member

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    Sorry to be unhelpful here:

    Wow!
    then Sigh...
     
  3. Marky90

    Marky90 Science breeds knowledge, opinion breeds ignorance

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    Basically my response too! Very very disappointing, especially in light of phase 2 who came out so good, and considering so many patients have waited so long for a positive result.
     
    MastBCrazy, simeyss, Orla and 4 others like this.
  4. MartinDH

    MartinDH Senior Member

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    Tough!

    Maybe identifying the subgroups is much more important than I thought. Because: I don't think that a total remission in CFS due to RTX treatment (which occurred in Phase II) can be placebo.

    Or they really messed up diagnostic criteria ;-)
     
    TrixieStix, Learner1, Mary and 12 others like this.
  5. Scarecrow

    Scarecrow Revolting Peasant

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    Overall, such disappointing news but there does seem to be a suggestion that it's effective in a minority group. And if that's true, it's still something positive to take from the trials. Fingers crossed that UCL can elucidate what's going on.
     
    Mel9, Mary, MastBCrazy and 15 others like this.
  6. mattie

    mattie

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    That is seriously bad news. :thumbdown:
     
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  7. Marky90

    Marky90 Science breeds knowledge, opinion breeds ignorance

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    It`s anyone's guess.. Maybe the use of activity trackers played a role
     
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  8. ivorin

    ivorin Senior Member

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    Thank you for sharing this - hopefully they are still able to identify the subgroup it was helping - might proove beneficial going forward.
     
    Mary, andyguitar, Nico and 8 others like this.
  9. BS3boy

    BS3boy

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    I really think they need to subgroup seriously for this sort of thing, and do that with a rigorous battery of tests & also detailed interviews on illness history, and illness pathway patterns, for the trial participants. Maybe even using genetic information. Otherwise, you get a homogenous group of people with general symptoms that come under the CFS umbrella, and it's hardly surprising that a drug is shown to not work on all of them .

    Sad news , and I worry the BPS bridage will be feeling a little more smug that yet more targeted bio / drug research has, apparently, failed to produce a positive result for us.
     
    Countrygirl, Learner1, Mary and 17 others like this.
  10. Grigor

    Grigor Senior Member

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    That's very very sad news....
     
    fireflymd, simeyss, soofke and 7 others like this.
  11. perrier

    perrier Senior Member

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    It's just awful news, just so drenching, so demoralizing.
    But now more and more I'm starting to wonder maybe folks don't all have the same illness at all.
     
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  12. perrier

    perrier Senior Member

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    Is Dr Davis there or not? I read that he was not, then that he was. If anyone knows, please update.
     
  13. Marky90

    Marky90 Science breeds knowledge, opinion breeds ignorance

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    Yep.

    Same here, to some degree. I also suspect however that its a good example of the importance of objective measures in a study.
     
    TrixieStix, simeyss, Kati and 5 others like this.
  14. Marky90

    Marky90 Science breeds knowledge, opinion breeds ignorance

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    He sent a video clip
     
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  15. MartinDH

    MartinDH Senior Member

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    That would be bad news. Because if they find sth. for one group..........
    But I think that the underlying cause has to be the same since Dr. Davis nano-chip seems to work on all CFS patients...
     
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  16. alex3619

    alex3619 Senior Member

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    I was just thinking about Rituximab as I was logging on, then found this thread. Its disappointing news, but not uncommon in phase 3 trials. The BPS crowd shouldn't be smug though, if they tested with this standard of rigour all their treatments would most likely fail. Instead they just don't do sound studies.
     
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  17. Simon

    Simon

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    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.
     
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  18. Londinium

    Londinium Senior Member

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    Well this is a kick to the guts. Main question now is whether negative result was p=0.5 (total failure) or p=0.06 (trend but need to test further / weed out unaffected subgroups).
     
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  19. Vicki Cole

    Vicki Cole

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    I'm left thinking...
    Will there ever be a way out of this damned disease :(

    Feel sad.
     
  20. deleder2k

    deleder2k Senior Member

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    Mel9, merylg, aimossy and 10 others like this.

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