Kenji Nagasaka1,2, Masayoshi Harigai3, Noboru Hagino4, Akinori Hara5, Tetsuya Horita6, Taichi Hayashi7, Mitsuyo Itabashi8, Satoshi Ito9, Yasuhiro Katsumata10, Soko Kawashima11, Taio Naniwa12, Ken-Ei Sada13, Eishu Nango14, Takeo Nakayama15, Michi Tsutsumino10, Kunihiro Yamagata16, Sakae Homma17, Yoshihiro Arimura11. 1. a Department of Rheumatology , Ome Municipal General Hospital , Tokyo , Japan. 2. b Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences , Tokyo Medical and Dental University , Tokyo , Japan. 3. c Division of Epidemiology and Pharmacoepidemiology, Department of Rheumatology, School of Medicine , Tokyo Women's Medical University , Tokyo , Japan. 4. d Division of Hematology and Rheumatology , Teikyo University Chiba Medical Center , Chiba , Japan. 5. e Department of Environmental and Preventive Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences , Kanazawa University , Ishikawa , Japan. 6. f Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine , Hokkaido University , Hokkaido , Japan. 7. g Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Ibaraki , Japan. 8. h Department of Nephrology , Tokyo Metropolitan Geriatric Hospital , Tokyo , Japan. 9. i Department of Rheumatology , Niigata Rheumatic Center , Niigata , Japan. 10. j Department of Rheumatology, School of Medicine , Tokyo Women's Medical University , Tokyo , Japan. 11. k Department of Nephrology and Rheumatology, First Department of Internal Medicine , Kyorin University School of Medicine , Tokyo , Japan. 12. l Department of Respiratory Medicine, Allergy and Clinical Immunology , Nagoya City University Graduate School of Medical Sciences , Nagoya , Japan. 13. m Department of Nephrology, Rheumatology, Endocrinology and Metabolism , Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences , Okayama , Japan. 14. n Department of General Medicine , Tokyo Kita Medical Center , Tokyo , Japan. 15. o Department of Health Informatics, Graduate School of Medicine and Public Health , Kyoto University , Kyoto , Japan. 16. p Department of Nephrology, Faculty of Medicine , University of Tsukuba , Ibaraki , Japan. 17. q Department of Respiratory Medicine , Toho University Omori Medical Center , Tokyo , Japan.
Abstract
OBJECTIVES: To provide evidence for the revision of clinical practice guideline (CPG) for the management of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) by the Japan Research Committee for Intractable Vasculitis. METHODS: PubMed, CENTRAL, and the Japan Medical Abstracts Society were searched for articles published between January 1994 and January 2015 to conduct systematic review (SR), and the quality of evidence was assessed with GRADE approach. RESULTS: Nine randomized controlled trials (RCTs) and two non-RCTs were adopted for remission induction therapy, three RCTs and two non-RCTs for plasma exchange, and five RCTs and one non-RCT for remission maintenance therapy. A significant difference was found in efficacy and safety for the following comparisons. In the non-RCT adopted for remission induction therapy, glucocorticoid (GC) + cyclophosphamide (CY) was significantly superior to GC monotherapy regarding remission. GC + intravenous CY for remission induction therapy was superior to GC + oral CY regarding death at one year, serious adverse events, and serious infection. Concomitant use of plasma exchange for remission induction therapy of AAV with severe renal dysfunction reduced risk of end-stage renal disease versus non-users at month 3. CONCLUSION: This SR provided necessary evidence for developing CPG for the management of ANCA-associated vasculitis.
OBJECTIVES: To provide evidence for the revision of clinical practice guideline (CPG) for the management of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) by the Japan Research Committee for Intractable Vasculitis. METHODS: PubMed, CENTRAL, and the Japan Medical Abstracts Society were searched for articles published between January 1994 and January 2015 to conduct systematic review (SR), and the quality of evidence was assessed with GRADE approach. RESULTS: Nine randomized controlled trials (RCTs) and two non-RCTs were adopted for remission induction therapy, three RCTs and two non-RCTs for plasma exchange, and five RCTs and one non-RCT for remission maintenance therapy. A significant difference was found in efficacy and safety for the following comparisons. In the non-RCT adopted for remission induction therapy, glucocorticoid (GC) + cyclophosphamide (CY) was significantly superior to GC monotherapy regarding remission. GC + intravenous CY for remission induction therapy was superior to GC + oral CY regarding death at one year, serious adverse events, and serious infection. Concomitant use of plasma exchange for remission induction therapy of AAV with severe renal dysfunction reduced risk of end-stage renal disease versus non-users at month 3. CONCLUSION: This SR provided necessary evidence for developing CPG for the management of ANCA-associated vasculitis.