4.1 Article

Performance, clinical effectiveness, and safety of immunoadsorption in a wide range of indications

Journal

THERAPEUTIC APHERESIS AND DIALYSIS
Volume 26, Issue 1, Pages 229-241

Publisher

WILEY
DOI: 10.1111/1744-9987.13663

Keywords

clinical effectiveness; dilated cardiomyopathy; immunoadsorption; neurology; transplantation

Funding

  1. Fresenius Medical Care Deutschland GmbH

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This study aimed to assess the performance, safety, and clinical effectiveness of immunoadsorption in patients with various autoimmune diseases. The results showed that the treatments with both GLOBAFFIN and Immunosorba were well tolerated, effective in lowering immunoglobulins, and led to clinical improvement or stabilization in the majority of patients.
Immunoadsorption is well known to selectively remove immunoglobulins and immune complexes from plasma and is applied in a variety of autoimmune diseases and for desensitization before, or at acute rejection after organ transplantation. Performance, safety, and clinical effectiveness of immunoadsorption were the aim of this study. This prospective, noninterventional, multicentre cohort study included patients treated with immunoadsorption (Immunosorba or GLOBAFFIN adsorbers) for any indication. Clinical effectiveness was assessed after termination of the patient's individual treatment schedule. Eighty-one patients were included, 69 were treated with Immunosorba, 11 with GLOBAFFIN, one patient with both adsorbers. A majority of patients was treated for neurological indications, dilated cardiomyopathy, and before or after kidney or heart transplantation. Mean IgG reduction from pre- to post-treatment was 69.9% +/- 11.5% for Immunosorba and 74.1% +/- 5.0% for GLOBAFFIN, respectively. The overall IgG reduction over a complete treatment block was 68%-93% with Immunosorba and 62%-90% with GLOBAFFIN depending on the duration of the overall treatment. After termination of the immunoadsorption therapy, an improvement of clinical status was observed in 63.0%, stabilization of symptoms in 29.6%, and a deterioration in 4.9% of patients. Changes in fibrinogen, thrombocytes, and albumin were mostly classified as noncritical. Overall, the treatments were well tolerated. Immunoadsorption in routine clinical practice with both GLOBAFFIN and Immunosorba has been safely performed, was well tolerated by patients, and effective in lowering immunoglobulins with an improvement or maintenance of clinical status, thus represents an additional therapeutic option for therapy refractory immune disorders.

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