Tolerability and Efficacy of s.c. IgG Self-Treatment in ME/CFS Patients with IgG/IgG Subclass Deficiency : A Proof-of-Concept Study
BACKGROUND: Chronic fatigue syndrome (ME/CFS) is a complex disease frequently triggered by infections. IgG substitution may have therapeutic effect both by ameliorating susceptibility to infections and due to immunomodulatory effects.
METHODS: We conducted a proof of concept open trial with s.c. IgG in 17 ME/CFS patients suffering from recurrent infections and mild IgG or IgG subclass deficiency to assess tolerability and efficacy. Patients received s.c. IgG therapy of 0.8 g/kg/month for 12 months with an initial 2 months dose escalation phase of 0.2 g and 0.4 g/kg/month.
RESULTS: Primary outcome was improvement of fatigue assessed by Chalder Fatigue Scale (CFQ; decrease ≥ 6 points) and of physical functioning assessed by SF-36 (increase ≥ 25 points) at month 12. Of 12 patients receiving treatment per protocol 5 had a clinical response at month 12. Two additional patients had an improvement according to this definition at months 6 and 9. In four patients treatment was ceased due to adverse events and in one patient due to disease worsening. We identified LDH and soluble IL-2 receptor as potential biomarker for response.
CONCLUSION: Our data indicate that self-administered s.c. IgG treatment is feasible and led to clinical improvement in a subset of ME/CFS patients.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Journal of clinical medicine - 10(2021), 11 vom: 29. Mai |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Scheibenbogen, Carmen [VerfasserIn] |
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| Links: |
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| Themen: |
Autoimmunity |
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| Anmerkungen: |
Date Revised 15.06.2021 published: Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3390/jcm10112420 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM326209867 |
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| 100 | 1 | |a Scheibenbogen, Carmen |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Tolerability and Efficacy of s.c. IgG Self-Treatment in ME/CFS Patients with IgG/IgG Subclass Deficiency |b A Proof-of-Concept Study |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Revised 15.06.2021 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a BACKGROUND: Chronic fatigue syndrome (ME/CFS) is a complex disease frequently triggered by infections. IgG substitution may have therapeutic effect both by ameliorating susceptibility to infections and due to immunomodulatory effects | ||
| 520 | |a METHODS: We conducted a proof of concept open trial with s.c. IgG in 17 ME/CFS patients suffering from recurrent infections and mild IgG or IgG subclass deficiency to assess tolerability and efficacy. Patients received s.c. IgG therapy of 0.8 g/kg/month for 12 months with an initial 2 months dose escalation phase of 0.2 g and 0.4 g/kg/month | ||
| 520 | |a RESULTS: Primary outcome was improvement of fatigue assessed by Chalder Fatigue Scale (CFQ; decrease ≥ 6 points) and of physical functioning assessed by SF-36 (increase ≥ 25 points) at month 12. Of 12 patients receiving treatment per protocol 5 had a clinical response at month 12. Two additional patients had an improvement according to this definition at months 6 and 9. In four patients treatment was ceased due to adverse events and in one patient due to disease worsening. We identified LDH and soluble IL-2 receptor as potential biomarker for response | ||
| 520 | |a CONCLUSION: Our data indicate that self-administered s.c. IgG treatment is feasible and led to clinical improvement in a subset of ME/CFS patients | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a IgG deficiency | |
| 650 | 4 | |a IgG replacement | |
| 650 | 4 | |a autoimmunity | |
| 650 | 4 | |a biomarker | |
| 650 | 4 | |a chronic fatigue syndrome | |
| 650 | 4 | |a immunology | |
| 650 | 4 | |a myalgic encephalomyelitis | |
| 700 | 1 | |a Sotzny, Franziska |e verfasserin |4 aut | |
| 700 | 1 | |a Hartwig, Jelka |e verfasserin |4 aut | |
| 700 | 1 | |a Bauer, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Freitag, Helma |e verfasserin |4 aut | |
| 700 | 1 | |a Wittke, Kirsten |e verfasserin |4 aut | |
| 700 | 1 | |a Doehner, Wolfram |e verfasserin |4 aut | |
| 700 | 1 | |a Scherbakov, Nadja |e verfasserin |4 aut | |
| 700 | 1 | |a Loebel, Madlen |e verfasserin |4 aut | |
| 700 | 1 | |a Grabowski, Patricia |e verfasserin |4 aut | |
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