Immunoadsorption apheresis for severe systemic lupus erythematosus with nephritis: a pivotal study

IMMUNOADSORPTION APHERESIS FOR SEVERE SYSTEMIC LUPUS ERYTHEMATOSUS WITH NEPHRITIS: A PIVOTAL STUDYClaudia Stefanutti, M.D.,Ph.D.Extracorporeal Therapeutic Techniques Unit - Immunohematology and Transfusion Medicine, University of Rome 'La Sapienza', ROME, ItalyIntroduction: The prognosis of patients with severe systemic lupus erythematosus (SLE) who have glomerulonephritis is poor, despite treatment with immunosuppressive therapy. Indications for the use of apheresis technologies in managing SLE have undergone numerous remodelling since the first attempt of treatment in 1974. Once thought to be a promising treatment for SLE, apheresis has been limited as an adjunct in managing the disorder. Immunoadsorption Apheresis (IA) has been only recently used to a wider extent in complicated autoimmune diseases. Aim: Randomized, controlled data related to the treatment of autoimmune diseases with IA and immunosuppressive therapy, are still scarce. To assess effectiveness and safety IA was given in combination with immunosuppressive drugs to five patients with severe complicated SLE in a pivotal open label study.Patients and Methods: Five patients with severe SLE and nephritis, who had not responded to conventional therapy, were submitted to IA (Selesorb®, Kaneka MA-03 System, Osaka-Japan) and subsequent pulse cyclophosphamide. Results:Patient M/F Age Complication IA sessions Remission1 F 44 VasculitisNephritis 18 YesNo2 F 26 Nephritis 12 Yes3 M 28 Nephritis 12 Yes4 F 35 Nephritis 15 Yes5 F 49 Nephritis 17 YesIA in combination with immunosuppressive drugs showed to be effective in 4 patients and of limited efficacy in 1 individual, as reported above. Conclusion: Further investigations, increase in the number of subjects to be studied, a multicenter study approach, and a long-term follow-up are necessary to confirm the advantages of IA. It is to be underlined that adverse events are very rare and advances in apheresis technologies, like immunoadsorption, might, in the future, play a role in the therapeutic approach for severe SLE.References:Stefanutti C et al., Cyclophosphamide and Immunoadsorption Apheresis Treatment of Lupus Nephritis Nonresponsive to Drug Therapy Alone. BioDrugs, 2005; 19(2):129-133.Stefanutti C et al., Immunoadsorption apheresis and immunosuppressive drug therapy in the treatment of complicated HCV-related cryoglobulinemia. J Clin Apher. 2009;24(6):241-6