Download This Paper
Preprints with The Lancet is a collaboration between The Lancet Group of journals and SSRN to facilitate the open sharing of preprints for early engagement, community comment, and collaboration. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early-stage research papers that have not been peer-reviewed. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. The findings should not be used for clinical or public health decision-making or presented without highlighting these facts. For more information, please see the FAQs.
Efficacy of Repeat Immunoadsorption in Post-COVID ME/CFS Patients with Elevated Β2-Adrenergic Receptor Autoantibodies: A Prospective Cohort Study
27 Pages Posted: 1 Aug 2024
More...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.
Funding: Funded by The Federal Ministry of Education and Research and the Weidenhammer Zöbele Research Foundation.
Declaration of Interest: Charité holds, together with CellTrend, a patent for the diagnostic use of autoantibodies against β2 AR-AB. CS has a consulting agreement with CellTrend and Berlin Cures. The other authors declare no conflict of interest.
Ethical Approval: The Ethics Committee of the Charité - Universitätsmedizin Berlin approved this study in accordance with the 1964 Declaration of Helsinki and its later amendments (protocol code EA2/134/22, date of approval: 28 July 2022).
Keywords: myalgic encephalomyelitis, chronic fatigue syndrome, COVID-19, SARS-CoV-2, pandemic, post-COVID syndrome, immunoadsorption, plasmapheresis, autoantibodies
Suggested Citation: Suggested Citation