Apheresis Therapy for ANCA-associated Vasculitis : Plasma Exchange and Glucocorticoids in Anti-neutrophil Cytoplasm Antibody Associated Vasculitis:A Randomized Controlled Trial (PEXIVAS)

NDL Digital Collections
  • Ito-Ihara,Toshiko
    Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital
  • Fujimoto,Shouichi
    Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
  • Suzuki,Kazuo
    The Institute of Asia International Infectious Disease Control, Teikyo University:Department of Health Protection, Graduate School of Medicine, Teikyo University:Safety Control Department, Teikyo University Hospital
  • Endo,Tomomi
    Division of Nephrology and Dialysis, Center for Nephrology and Dialysis, Kitano Hospital, The Tazuke Kofukai Medical Research Institute
  • Muso,Eri
    Division of Nephrology and Dialysis, Center for Nephrology and Dialysis, Kitano Hospital, The Tazuke Kofukai Medical Research Institute
  • PEXIVAS-JP Group

Bibliographic Information

Other Title
  • ANCA関連血管炎に対するアフェレシス療法 : 抗好中球細胞質抗体関連血管炎に対する血漿交換療法と国際共同臨床試験PEXIVAS(<特集>血管炎症候群とアフェレシス)

Search this article

Description

Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) results in high rates of morbidity and mortality due to uncontrolled disease and treatment toxicity. Randomized trials and a meta-analysis suggest adjunctive plasma exchange may improve disease control, while observational evidence suggests that current oral glucocorticoid doses are associated with severe infections in patients with AAV. A randomized study of both plasma exchange and glucocorticoids is required to evaluate plasma exchange and oral glucocorticoid dosing in patients with AAV. PEXIVAS is a two by two factorial design randomized trial evaluating adjunctive plasma exchange and two oral glucocorticoid regimens in severe AAV. Seven hundred patients are being randomized at centers across Europe, North America, Japan and Australia to receive plasma exchange or no plasma exchange, and to receive standard or reduced oral glucocorticoid dosing. All patients receive immunosuppression with either cyclophosphamide or rituximab. The primary outcome is the time to the composite of all-cause mortality and end-stage renal disease. PEXIVAS is the largest trial in AAV undertaken to date and will inform the future standard of care for patients with severe AAV. Trial Registrations : EudraCT 2009-013220-24, ISRCTN07757949, NCT00987389, UMIN000009523.

Journal

Keywords

Details 詳細情報について

Report a problem

Back to top