Department of Neurology, University Hospital, Regensburg, Germany.
Institute for Transfusion Medicine, University Hospital, Jena, Germany.
Ther Apher Dial. 2022 Feb;26(1):229-241. doi: 10.1111/1744-9987.13663. Epub 2021 May 6.
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.
免疫吸附法是一种从血浆中选择性去除免疫球蛋白和免疫复合物的方法，已应用于多种自身免疫性疾病，并在器官移植前或急性排斥反应时进行脱敏治疗。本研究旨在评估免疫吸附的性能、安全性和临床疗效。这是一项前瞻性、非干预性、多中心队列研究，纳入了接受免疫吸附（免疫吸附剂或 GLOBAFFIN 吸附剂）治疗的任何适应症患者。在患者个体化治疗方案结束后评估临床疗效。共纳入 81 例患者，69 例接受免疫吸附剂（免疫吸附剂或 GLOBAFFIN 吸附剂）治疗，11 例接受 GLOBAFFIN 治疗，1 例同时接受两种吸附剂治疗。大多数患者因神经疾病、扩张型心肌病、肾或心脏移植前或后接受治疗。免疫吸附剂治疗后 IgG 较治疗前的平均降幅为 69.9%±11.5%，GLOBAFFIN 为 74.1%±5.0%。根据总体治疗时间，免疫吸附剂的 IgG 总体降幅为 68%-93%，GLOBAFFIN 为 62%-90%。免疫吸附治疗结束后，63.0%的患者临床状况改善，29.6%的患者症状稳定，4.9%的患者病情恶化。纤维蛋白原、血小板和白蛋白的变化大多被归类为非危急值。总体而言，治疗效果良好，耐受性好。在常规临床实践中，GLOBAFFIN 和免疫吸附剂均安全有效，可降低免疫球蛋白，改善或维持临床状况，为治疗难治性免疫疾病提供了一种额外的治疗选择。
