Preprint Efficacy of Repeat Immunoadsorption in Post-COVID ME/CFS Patients with Elevated B2-Adrenergic Receptor Autoantibodies - 2024, Stein, Scheibenbogen

Discussion in 'ME/CFS research' started by Kalliope, Aug 1, 2024.

  1. Kalliope

    Kalliope Senior Member (Voting Rights)

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    The Lancet: Efficacy of Repeat Immunoadsorption in Post-COVID ME/CFS Patients with Elevated B2-Adrenergic Receptor Autoantibodies: A Prospective Cohort Study

    Abstract
    Background: Since the pandemic, SARS-CoV-2 has become the leading trigger for ME/CFS. Evidence indicates autoimmunity plays an important pathophysiological role.

    Methods: This prospective cohort study included 20 post-COVID ME/CFS patients found to have elevated β2 AR-AB between October 2022 and October 2023. They received five immunoadsorption sessions at the Charité Universitätsmedizin Berlin, Germany. Response was defined as ≥ ten-point increase in the SF-36 PF four weeks post immunoadsorption. Key symptoms were assessed via questionnaires over six months. Handgrip strength and EndoPAT measurements were used to evaluate muscle fatigue and vascular dysfunction. Seven out of 14 patients who worsened after initial response received a second cycle.

    Findings: The treatment was generally well tolerated, reducing total IgG by 79·15 % (IQR: 75·47 – 83·19%) and β2 AR-AB by 78·14 % (IQR: 67·06 – 86·18%). 14 out of 20 patients responded to the treatment with an increase in the median SF-36 PF score from 25 to 60. Improvements were reported in fatigue (p = 0·028), post-exertional malaise (p = 0·005), pain (p = 0·007), cognitive (p = 0·010), autonomic (p = 0·004), and immunological (p = 0·001) symptoms. Female patients had increased handgrip strength (p = 0·036). In most patients symptoms worsened again after six months.

    Interpretation: Immunoadsorption can temporarily improve symptoms in post-COVID ME/CFS patients. The beneficial effects of IgG depletion suggest a significant role for autoantibodies and disturbed B-cell function in the condition’s pathophysiology.


    https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4911576
     
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  2. Kalliope

    Kalliope Senior Member (Voting Rights)

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    Scheibenbogen on Twitter:

    Our Charité study on immunoadsorption in post-COVID MECFS as a preprint in Lancet: 14 out of 20 improved, but mostly not long-lasting. We are preparing studies on the combination of immunoadsorption with B cell depletion.

     
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  3. Hutan

    Hutan Moderator Staff Member

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    Please can they blind these future studies?

    Two thirds of patients improving from 25 to 60 on the SF-36 PF score over 6 months in a small unblinded study is interesting, but still within the bounds of a placebo response.
     
    Last edited: Aug 2, 2024
  4. Hutan

    Hutan Moderator Staff Member

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    They don't say that SF-36 was the primary outcome. A lot (really a lot) of other things were measured too, e.g. Fatigue Severity Scale, Bell score, PEM-DSQ.
    It's looking as though the assessment point was actually 4 weeks after treatment. An assessment period that short is especially prone to bias in an unblinded study.

    Also, the 20 participants were noted to want to undergo the treatment - they were selected out of a larger group. The median disease duration was only 22 months, which I guess is unavoidable with the post-Covid selection. And the 20 participants were characterised as having severe disability (usually housebound).
     
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  5. Hutan

    Hutan Moderator Staff Member

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    Screen Shot 2024-08-02 at 5.43.38 pm.png

    Figure 1: a is the responders, b is the non-responders. SF-36 PF
     
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  6. Hutan

    Hutan Moderator Staff Member

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  7. Murph

    Murph Senior Member (Voting Rights)

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    it's not the sort of ultra cure you might hope for when matching a treatment to a defined subset. And with people whose course of illness is short, you'd expect some spontaneous remissions. Definitely ambiguous to me whether they have something there.
     
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  8. Simon M

    Simon M Senior Member (Voting Rights)

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    Thanks for all the great analysis (as usual).

    And yes, I think the Rituximab open label study showed at least as big an effect, while the blinded follow-up showed none.

    This study is similarly unblinded with no control, only this time with very short duration where significant improvement might be expected. A full blinded, controlled study would be interesting.
     
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  9. V.R.T.

    V.R.T. Senior Member (Voting Rights)

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    I'm endlessly frustrated by studies like these! Is the idea just to get funding for a double-blind study

    Because it would be really valuble to know if this stuff actually worked.
     
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  10. Kitty

    Kitty Senior Member (Voting Rights)

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    Or is it to make money selling their treatment to desperate people.
     
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