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1000 Titel
  • Fatigue, depression, and product tolerability during long-term treatment with intravenous immunoglobulin (Gamunex® 10%) in patients with chronic inflammatory demyelinating polyneuropathy
1000 Autor/in
  1. Klehmet, Juliane |
  2. Tackenberg, Björn |
  3. Haas, Judith |
  4. Kieseier, Bernd C. |
1000 Verlag BioMed Central
1000 Erscheinungsjahr 2023
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2023-05-26
1000 Erschienen in
1000 Quellenangabe
  • 23(1):207
1000 Copyrightjahr
  • 2023
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s12883-023-03223-5 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214666/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:sec> <jats:title>Abstract</jats:title> </jats:sec><jats:sec> <jats:title>Introduction/Aims</jats:title> <jats:p>Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is characterized by progressive weakness and sensory loss, often affecting patient’s ability to walk and perform activities of daily living independently. Furthermore, patients often report fatigue and depression which can affect their quality of life. These symptoms were assessed in CIDP patients receiving long-term intravenous immunoglobulin (IVIG) treatment.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>GAMEDIS was a multi-center, prospective, non-interventional study in adult CIDP patients treated with IVIG (10%) and followed for two years. Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Hughes Disability Scale (HDS), Fatigue Severity Scale (FSS), Beck Depression Inventory II (BDI), Short Form-36 health survey (SF-36) and Work Productivity and Activity Impairment Score Attributable to General Health (WPAI-GH) were assessed at baseline and quarterly. Dosing and treatment intervals, changes in outcome parameters, and adverse events (AEs) were analyzed.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>148 evaluable patients were followed for a mean of 83.3 weeks. The mean maintenance IVIG dose was 0.9 g/kg/cycle (mean cycle interval 38 days). Disability and fatigue remained stable throughout the study. Mean INCAT score: 2.4 ± 1.8 at baseline and 2.5 ± 1.9 at study end. HDS: 74.3% healthy/minor symptoms at baseline and 71.6% at study end. Mean FSS: 4.2 ± 1.6 at baseline and 4.1 ± 1.7 at study end. All patients reported minimal/no depression at baseline and throughout. SF-36 and WPAI-GH scores remained stable. Fifteen patients (9.5%) experienced potentially treatment-related AEs. There were no AEs in 99.3% of infusions.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>Long-term treatment of CIDP patients with IVIG 10% in real-world conditions maintained clinical stability on fatigue and depression over 96 weeks. This treatment was well-tolerated and safe.</jats:p> </jats:sec>
1000 Sacherschließung
lokal Adult [MeSH]
lokal Humans [MeSH]
lokal Prospective Studies [MeSH]
lokal Immunoglobulins, Intravenous/adverse effects [MeSH]
lokal Real-world evidence
lokal Treatment Outcome [MeSH]
lokal CIDP
lokal Patient-reported outcome measures
lokal Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/diagnosis [MeSH]
lokal Medical and Health Sciences
lokal Quality of life
lokal IVIG
lokal Quality of Life [MeSH]
lokal Research
lokal Activities of Daily Living [MeSH]
lokal Fatigue/diagnosis [MeSH]
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/uri/S2xlaG1ldCwgSnVsaWFuZQ==|https://frl.publisso.de/adhoc/uri/VGFja2VuYmVyZywgQmrDtnJu|https://frl.publisso.de/adhoc/uri/SGFhcywgSnVkaXRo|https://frl.publisso.de/adhoc/uri/S2llc2VpZXIsIEJlcm5kIEMu
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  1. Grifols |
  2. Universitätsklinikum Düsseldorf. Anstalt öffentlichen Rechts |
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    1000 Förderer Grifols |
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    1000 Förderer Universitätsklinikum Düsseldorf. Anstalt öffentlichen Rechts |
    1000 Förderprogramm -
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