| 초록 |
Objectives: We evaluated the efficacy and safety of eculizumab in comparison with plasmapheresis (PP) and intravenous immunoglobulin (IVIG) therapy in renal transplant recipients diagnosed with antibody-mediated rejection (AMR).
Methods: This was a multi-center, open-label, prospective, randomized analysis. The patients were randomized as to therapy type (eculizumab infusions or standard of care, SOC: PP/IVIG). The patients were evaluated for the continuing presence of donor-specific antibodies (DSAs) and C4d (staining on biopsy), as well as histological evidence, using repeat renal biopsies after treatment.
Results: The allograft biopsies revealed that eculizumab did not prevent the progression to transplant glomerulopathy. Only 2 patients in the SOC arm experienced rejection reversal, and no graft losses occurred in either group. Following AMR treatment, the DSA titers generally decreased compared to titers taken at the time of AMR diagnosis. There were no serious adverse effects in the eculizumab arm.
Conclusions: Eculizumab alone is not sufficient to treat AMR and does not prevent acute AMR from progressing to chronic AMR or to transplant glomerulopathy. However, it should be considered as a potential alternative therapy because it may be associated with decreased DSA levels. |