Safety, Efficacy and Clinical Outcome of the Immunosorba® and GLOBAFFIN® System
- Conditions
- HLA-ImmunisationMedDRA - 10000206: AB0 inkompability in transplantationL10.0G70.0G04.8Pemphigus vulgarisFailure and rejection of unspecified transplanted organ and tissueG61.0T86.9Other encephalitis, myelitis and encephalomyelitisGuillain-Barré syndrome
- Registration Number
- DRKS00005097
- Lead Sponsor
- Fresenius Medical Care Deutschland GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 81
Signed informed consent and treatment with Immunosorba®- bzw. GLOBAFFIN®-system
Patient unable to consent or patients less than 18 years
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of IgG-concentration in blood during one apheresis session, pre,post<br>
- Secondary Outcome Measures
Name Time Method Immunglobulin (IgM, IgA) reduction, Reduction of specific antibodies (as measured)during one apheresis session, pre,post;<br>Indication of immune apheresis ; clinical outcome using disease-specific questionnaire from start of apheresis treatment until 12 months later.<br>