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Safety Aspects of Immunoadsorption in IgG Removal Using a Single‐Use, Multiple‐pass Protein A Immunoadsorber (LIGASORB): Clinical Investigation in Healthy Volunteers
Author(s) -
Süfke Sven,
Lehnert Hendrik,
UhlenbuschKörwer Ingrid,
Gebauer Frank
Publication year - 2017
Publication title -
therapeutic apheresis and dialysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.415
H-Index - 53
eISSN - 1744-9987
pISSN - 1744-9979
DOI - 10.1111/1744-9987.12532
Subject(s) - immunoadsorption , medicine , apheresis , autoantibody , single center , immunology , antibody , fibrinogen , immunoglobulin g , prospective cohort study , platelet
Therapeutic apheresis and immunoadsorption are used to deplete efficiently pathogenic autoantibodies in crises in several acute autoimmune driven diseases. This prospective, non‐comparative cohort study was conducted at a single study center under standardized conditions in 10 healthy volunteers. Efficient immunoglobulin G (IgG) removal (−86% versus baseline) was achieved after 3 apheresis treatments on 3 consecutive days. The treatments were well tolerated. Safety laboratory parameters did not show unexpected or pathological changes. The effects were transient, with most parameters exhibiting complete recovery between treatments. Minimal complement activation and moderate transient fibrinogen depletion were observed. Immunoadsorption with LIGASORB® provides a safe and effective treatment alternative to TPE in acute episodes of peripheral neurological diseases mediated by pathogenic IgG autoantibodies.