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Interesting blog post regarding Norwegian ME/CFS developments. (Mella&Fluge research)

Discussion in 'Rituximab: News and Research' started by FancyMyBlood, May 6, 2012.

  1. FancyMyBlood

    FancyMyBlood Senior Member

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    I just stumbled on this Norwegian blog that talks about ME/CFS research. Unfortunately, Google Translate is still far away from perfect translations but this is what I got out of it:

    - Mella and Fluge are doing an new trial with etanercept (a TNF-inhibitor). They're giving 50mg injections weekly for 52 weeks. 15 non-responders will be recruited out of earlier rituximab studies. After 12 months there will be a follow-up, so the study ends in 2014. Unfortunately it doesn't seem to be placebo-controlled. They hypothesize that the amount of auto-antibodies in the rituximab trial was too high and etanercept may be a alternative treatment. As a second hypothesis they believe that activated T-cells play an important role in symptoms maintenance. Etanercept will 'hit' other facets of autoimmunity, not related to B-cells. At last they hypothesize that some non-responders do fulfill ME/CFS diagnostic criteria but don't have an immunological mediated profile. So a psychological condition with fatigue symptoms.

    - The Norwegian health authorities have written an annual report about research projects. Olav Mella was a research director and it states that the rituximab trial supports the hypothesis that ME/CFS is an illness with immune dysregulation, probably caused by auto-immune mechanism(s). The clinical results with a 3-8 month delay seem to indicate a gradually elimination of auto-antibodies. The clinical picture suggests involvement of the nervous system, probably a malfunction is neurotransmission. They then talk about systematically mapping auto-antibodies in sera of patients in their clinical studies and then Google Translate makes it gibberish. It seems to say something about cDNA expression, rat brains, West-immunoblot and immunohistology. Then it get's even more gibberish, which is very unfortunate because it looks like interesting new information (it's about advanced proteomic analysis, 2D electoblabla).
    It becomes readable again when they say they have analysis of 50 cytokines in 2011 sera samples of patients pre-treatment. These samples will be used as a basis for the analysis of selected cytokines at a 12 month follow-up after B-cell depletion. They've also started with measuring lymphocytes gene expression after a standarized physical stress test in patient with mild to moderate ME/CFS. They're using RT-PCR - Taqman and the same technique is also used for measure EBV in patients. In collaboration with a Berlin university they measured immunoreactivity against EBV (several and epitopes on the virus), before and after 8 months of rituximab treatment. Both responders and non-responders participated in this. Thanks to the Kavli foundation the search for mechanism and biomarkers will be intensivated in 2012!

    There is more on the blog, but it's too much effort to type it all out ATM (reading takes about 5 minutes, typing it out about half an hour!). I hope I translated it alright, if not hopefully a Norwegian patient can correct me and complement the gibberish translations :D
     
    merylg, Tito, Bob and 8 others like this.
  2. mhj

    mhj

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    Norwegian Science trials Etanercept as treatment for chronic fatigue syndrome (CFS/ME

    Norwegian Science trials Etanercept as treatment for chronic fatigue syndrome (CFS/ME)

    A short introduction of the studyprotocol to the Dept. of Oncology, Haukeland University Hospital, Bergen, Norway by Olav Mella and ystein Fluge named: English Tumor necrosis factor-alpha inhibitor etanercept as treatment for chronic fatigue syndrome/ myalgic encephalopathy (CFS/ME), including for patients with no response to treatment with the anti-CD20 antibody Rituximab

    The open single trial is ongoing and ends in 2014 after the last patient 24 moths follow-up. This study has to be viewed as a pilot study. Data from this study can form the basis for future studies and treatment aimed at confirming possible findings. The study protocol is released and supervised by Norwegian National Committee for Ethics in Medical Research (REK). EudraCT number: 2011-006069-16.

    The pathophysiology of CFS is not clear and highly debated. Studies aimed at identifying biomarkers for CFS patients may greatly benefit the identification of patients. Furthermore, insights into the pathophysiology of disease may facilitate novel therapies. This trial is aimed for patients that did not respond (non-responders) to the Rituximab treatment.

    Maximim duration of treatment of a subject according to the protocol:

    etanercept 50 mg injections subcutaneously (SC) once every week, for a maximum of 52 weeks.

    Participations: 15 patients who fulfill Fakuda- criteria recruited from the Rituximab-trial.

    Main objective of the trial:
    Patients self-recording of CFS/ME symptom improvement and quality of life issues during 12 months follow-up. The primary endpoint is selfreported major symptom improvement lasting at least for six consecutive weeks, independent of time after intervention during followup.

    Single such periods of major improvement, and the sum of these during 12 months follow-up, are recorded.
    -Self-reported symptom improvement at 3, 6, 9, 12 months follow-up after start of intervention.
    -Duration of maximal continous major response during follow-up.
    -Toxicity during follow-up.

    Inclusion criteria:
    -CFS/ME according to Fukuda criteria, moderate and serious.
    -Age 18-66 years

    Exclutions criteria:
    -Fatigue not fulfilling criteria for CFS/ME.
    -Pregnancy or lactation.
    -Previous malignancy (except basal cell carcinoma or cervical dysplasia)
    -Previous long-term immunosuppressive treatment (ciclosporin,
    mycophenolate mofetil, azathioprine)
    -demyelination disease
    -cardiac failure
    -endogenous depression
    -lack of ability to adhere to protocol
    -known multi-allergy with risk from etanercept injection
    -reduced liver function or kidney function
    -HIV infection or viral hepatitis. Latent tuberculosis.

    Etanercept (Embrel) is classified as an immunosuppressant drug. A relatively new drug (1988), etanercept blocks the effects of an immune agent called tumor necrosis factor -alpha (TNF-a) by binding to it and stopping it from interacting with bodys cells. TNF-a is an important cytokine the body uses to amplify the inflammatory response produced during infection. It has been called the master regulator of the immune response. TNF-a produces many of the symptoms associated with infection including fever and pain.

    KTS_4_2011_Clinical trial: Link: http://totoneimbehl.wordpress.com/2...udie/kts_4_2011_clinical-trial-soknad-utland/

    Note: This is a new trial to see if Embrel can be an alternative for non-responders. There is some info om this drug in this forum so take a serach.

    --------------
    The second that was mention here were a annual repport from the Univeristy Hospital in Bergen Haukeland that descrebed the reserch om patogenesis og ME called project 911557 where there are hunting for biomarkers. And hopefully they will find the auto-antibody "needle in a haystack"

    In the Fluge et. al (2011) PLosONE study there draw bloodsampels and contiued after in the fallow-up study that still is ongoing.

    I will assume Fluge or Mella will talk about the biobank and this prosject in Invest in ME conferance i May and the way foreward in next Rituximab-trials.

    ;)

    The biobank is starting to look impressing and they do collaborate with A Kogelnick, Klimas and so on - This is gooood stuff folks :D
     
    merylg, Jacque, Sherlock and 5 others like this.
  3. Enid

    Enid Senior Member

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    Good stuff as you say - thanks mhj.
     
  4. Cort

    Cort Phoenix Rising Founder

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    Very nice - great to see that they're moving forward - thanks for the update :
     
  5. taniaaust1

    taniaaust1

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    Happy to hear about treatment studies being done BUT
    I dont know why they dont make it a standard thing in ME/CFS studies to stop just relying on all the "self reporting" stuff and always make it so they are testing activity improvement levels etc as well.

    A good standard needs to be set to be measuring improvement in studies (if the patients are no different to a control group to start with as far as activity levels go.. they shouldnt then be in studies).

    There needs to be a higher standard for ME/CFS studies with always a control group. Till studies start being done better, Im not going to be happy with them.
     
    Tito and alex3619 like this.
  6. redo

    redo Senior Member

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    Here's a patient experience I dug up on Enbrel/Etanercept. Looks like it has potential. Most likely immune modulation for ME patients is like it is for those with e.g. RA/psoriasis/ulcerous colitis; what works for one doesn't necessarily work for all (like others also have pointed out).

    http://chronicfatigue.about.com/b/2008/01/07/17.htm

    If anyone else comes across other patient experiences, positive or negative, than please post them here.
     
  7. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    i just looked up enbrel, its an immune suppressant. Whats the theory of using it for me/cfs? Sounds abit scary in that some patients can get infections from it. one of the warnings is if u think you have an infection or a prone to infections of any kind then this medication shouldnt be started unless your doc says its ok.

    http://www.enbrel.com/what-is-ENBREL.jspx

    Its sounds interesting as it could possibly help us with inflammatory cytokines but lowering our immunity is a concern though.

    cheers!!!
     
    merylg likes this.
  8. ukxmrv

    ukxmrv Senior Member

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    I had a short trial of Humira (similar to Enbrel). Knew other patients who were taking Enbrel.

    The idea was to try and lower the TNF-a. Had tests before and after.

    The Humira did help with the viral symptoms that have been a major part of the ongoing ME for me.

    Dr Kerr was interested in doing a trail of Enbrel (and he had other similar ideas) in the UK before they have him the chop.
     
  9. redo

    redo Senior Member

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    I sent you a PM.

    Yes, I guess there's a risk with it. What I generally think is that if RA patients are using it (have been used for many years), there are bound to be people who both have ME and RA who've used it, as those conditions overlap to a certain degree, so it's been done before. There are some who've written about their experiences, and it didn't help them. But I haven't seen someone who has got a lot worse from it still.
     
  10. Tia

    Tia Senior Member

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    This sounds waaaay better than theother one since this ends in 2014. One year closer to target, muahahaa!
     
  11. Fred1234567

    Fred1234567

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    I mentioned enbrel to my oncologist and he said he thought it was more risky than rituximab?? Dr Don Staines has interesting papers on problems with the vasoactive neuropeptides being the cause of ME problems... his theory seems to explain a lot of the symptoms...
     
  12. currer

    currer Senior Member

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    Looks interesting. bump.
     
  13. natasa778

    natasa778 Senior Member

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    Bradstreet blogged about it a while ago


    also talks about risks and side effects. Few abstracts at the bottom.

    http://drbradstreet.org/2011/03/08/...ole-in-autism-and-more-and-stem-cell-therapy/
     
    currer likes this.
  14. natasa778

    natasa778 Senior Member

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    More on etanercept Alzheimer's study:

    http://www.musclemagfitness.com/dis...verse-alzheimers-symptoms-within-minutes.html


     
    redo and currer like this.
  15. Jacque

    Jacque Senior Member

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    Thank you so much for takin the time to write that out for us! Gives me such HOPE that they are now ON to the malfunctions of this beast of an illness ... and hopefully in time we will all get our answers. I know I am really interested in the Enbrel work in case the Rituxan does not do the job for me.
    Thanks again, Jac
     
  16. Tia

    Tia Senior Member

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    When I hear immune modulation, I think of Judy Mikovitz. Didn't she say the virus XMRV caused immune modulation that led to the fatigue? In that case, se was right!
     
  17. currer

    currer Senior Member

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    The immune system is certainly involved in perpetuating this illness. But we do not understand the trigger for developing this disease yet.
    Why is the immune system dysfunctional?
     
  18. Jacque

    Jacque Senior Member

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    My suspicion...and that is all it is... is LYME DISEASE!!! I had a tick crawl in my ear around age 12 and have been ill since about that time in my life. Coincidence? Lyme is spread by any blood sucking insect (not just ticks) and you don't have to get the rash. I am wondering if all of these autoimmune illnesses are Lyme? Lyme is stealthy... I am gonna post a thread on Lyme... If you have not watched Under Our Skin on Netflix...do it soon and then you will see what I am talking about!
     
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  19. Sherlock

    Sherlock tart cherry etc. for joints, insomnia

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    it has a greater risk of serious infections, probably a greater risk of overall infections, too.
     
  20. taniaaust1

    taniaaust1

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    But there are some places in the world eg Australia in which lyme disease hasnt been officially even found yet eg Australia, so it would be very hard to believe that all the Australian ME/CFS people have lyme. For that reason it has to be something different then actual lyme disease.

    Maybe thou another tick borne disease similar to lyme could be implicated thou. (I had a flea plague in my house and also do have ticks in the place I used to camp, I found one crawling up my shirt one time).
     
    IreneF likes this.

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