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. 2023 Oct 9;12(19):6428.
doi: 10.3390/jcm12196428.

Observational Study of Repeat Immunoadsorption (RIA) in Post-COVID ME/CFS Patients with Elevated ß2-Adrenergic Receptor Autoantibodies-An Interim Report

Elisa Stein  1 , Cornelia Heindrich  1 , Kirsten Wittke  1 , Claudia Kedor  1 , Laura Kim  1 , Helma Freitag  1 , Anne Krüger  2 , Markus Tölle  2 , Carmen Scheibenbogen  1
Affiliations

Observational Study of Repeat Immunoadsorption (RIA) in Post-COVID ME/CFS Patients with Elevated ß2-Adrenergic Receptor Autoantibodies-An Interim Report

Elisa Stein et al. J Clin Med. .

Abstract

There is increasing evidence for an autoimmune aetiology in post-infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). SARS-CoV-2 has now become the main trigger for ME/CFS. We have already conducted two small proof-of-concept studies on IgG depletion by immunoadsorption (IA) in post-infectious ME/CFS, which showed efficacy in most patients. This observational study aims to evaluate the efficacy of IA in patients with post-COVID-19 ME/CFS. The primary objective was to assess the improvement in functional ability. Due to the urgency of finding therapies for post-COVID-Syndrome (PCS), we report here the interim results of the first ten patients, with seven responders defined by an increase of between 10 and 35 points in the Short-Form 36 Physical Function (SF36-PF) at week four after IA. The results of this observational study will provide the basis for patient selection for a randomised controlled trial (RCT), including sham apheresis, and for an RCT combining IA with B-cell depletion therapy. Trial registration number: NCT05629988.

Keywords: GPCR-antibodies; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; SF-36; autoantibodies; immunoadsorption; long COVID; physical function; post-COVID syndrome.

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Conflict of interest statement

Charité holds, together with CellTrend, a patent for the diagnostic use of AABs against ADRB2. CS has a consulting agreement with CellTrend. The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(A) Levels of IgG, IgA, and IgM before IA, the morning before the 5th IA, and 4 weeks after IA. (B) Levels of ADRB2 AAB IgG, ADRB2 AAB IgA, and ADRB2 AAB IgM before IA, the morning before the 5th IA, and one month (M1) after IA. The period of IA treatment is indicated by a yellow area. ADRB2 AABs were determined by CellTrend GmbH, Luckenwalde, Germany, using ELISA technology. Statistics performed by Wilcoxon matched paired-signed rank test, * p < 0.05, ** p < 0.01.
Figure 2
Figure 2
(A) Physical function as assessed by the Short Form-36 (SF-36) in all patients (n = 10) before immunoadsorption (IA) and at months (M) 1, 2, and 3 post-IA. A higher score indicates better health. Statistics performed by Wilcoxon matched paired-signed rank test, * p < 0.05. (B) Physical function as assessed by the SF-36 in responders to IA (n = 7), before IA, and at months 1, 2, and 3 post-IA. Statistics performed by Wilcoxon matched paired-signed rank test, * p < 0.05.
Figure 3
Figure 3
Course of symptoms in responding patients (n = 7): muscle pain, headache, cognitive score, and immune score, as assessed by weighted Canadian Consensus Criteria symptoms. A higher score indicates more severe symptoms. Statistics performed by Wilcoxon matched paired-signed rank test, * p < 0.05.
Figure 4
Figure 4
Fatigue in responding patients (n = 7) was assessed by the Fatigue Severity Scale (FSS) before IA and after months 1, 2, and 3. A higher score indicates more severe fatigue. Statistics performed by Wilcoxon matched paired-signed rank test.
See this image and copyright information in PMC

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