TY - JOUR
T1 - Severity-based treatment for Japanese patients with MPO-ANCA-associated vasculitis
T2 - The JMAAV study
AU - Ozaki, Shoichi
AU - Atsumi, Tatsuya
AU - Hayashi, Taichi
AU - Ishizu, Akihiro
AU - Kobayashi, Shigeto
AU - Kumagai, Shunichi
AU - Kurihara, Yasuyuki
AU - Kurokawa, Manae S.
AU - Makino, Hirofumi
AU - Nagafuchi, Hiroko
AU - Nakabayashi, Kimimasa
AU - Nishimoto, Norihiro
AU - Suka, Machi
AU - Tomino, Yasuhiko
AU - Yamada, Hidehiro
AU - Yamagata, Kunihiro
AU - Yoshida, Masaharu
AU - Yumura, Wako
N1 - Funding Information:
Acknowledgments This study was supported by a grant-in-aid from the Ministry of Health, Labor, and Welfare of Japan. We thank Professor Loic Guillevin, Department of Internal Medicine, Hôspital Cochin, Paris, for critical reading of the manuscript and advice. The physicians participating in this study other than the authors were as follows: K. Amano (Saitama Medical Center, Kawagoe), Y. Arimura (Kyorin University, Mitaka), K. Hatta (Tenri Hospital, Tenri), S. Ito (Tsukuba University, Tsukuba), H. Kikuchi (Teikyo University, Tokyo), E. Muso (Kitano Hospital, Osaka), H. Nakashima (Fukuoka University, Fukuoka), Y. Ohsone (Kawasaki Municipal Kawasaki Hospital, Kawasaki), and Y. Suzuki (Tokai University, Isehara). The other members of the JMAAV Study Group included H. Hashimoto (Department of Internal Medicine and Rheumatology, Juntendo University), A. Koyama (Department of Nephrology, Graduate School of Comprehensive Human Sciences, University of Tsukuba), S. Matsuo (Department of Nephrology, Nagoya University Graduate School of Medicine), and H. Kato (Division of Clinical Proteomics and Molecular Medicine, St. Marianna University Graduate School of Medicine).
PY - 2012/6
Y1 - 2012/6
N2 - We (JMAAV [Japanese patients with MPOANCA- associated vasculitis] Study Group) performed a prospective, open-label, multi-center trial to evaluate the usefulness of severity-based treatment in Japanese patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA)-associated vasculitis. Patients with MPO-ANCA-associated vasculitis received a severitybased regimen according to the appropriate protocol: lowdose corticosteroid and, if necessary, cyclophosphamide or azathioprine in patients with mild form; high-dose corticosteroid and cyclophosphamide in those with severe form; and the severe-form regimen plus plasmapheresis in those with the most severe form. We followed up the patients for 18 months. The primary end points were the induction of remission, death, and end-stage renal disease (ESRD). Fifty-two patients were registered, and 48 patients were enrolled in this study (mild form, n = 23; severe form, n = 23; most severe form, n = 2). Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD. Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period. The JMAAV trial is the first prospective trial for MPO-ANCA-associated vasculitis to be performed in Japan. The remission and death rates were comparable to those in several previous clinical trials performed in western counties. The regimen employed in this trial was tailor-made based on patients' disease severity and disease type, and it seems that standardization can be consistent with treatment choices made according to severity.
AB - We (JMAAV [Japanese patients with MPOANCA- associated vasculitis] Study Group) performed a prospective, open-label, multi-center trial to evaluate the usefulness of severity-based treatment in Japanese patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies (MPO-ANCA)-associated vasculitis. Patients with MPO-ANCA-associated vasculitis received a severitybased regimen according to the appropriate protocol: lowdose corticosteroid and, if necessary, cyclophosphamide or azathioprine in patients with mild form; high-dose corticosteroid and cyclophosphamide in those with severe form; and the severe-form regimen plus plasmapheresis in those with the most severe form. We followed up the patients for 18 months. The primary end points were the induction of remission, death, and end-stage renal disease (ESRD). Fifty-two patients were registered, and 48 patients were enrolled in this study (mild form, n = 23; severe form, n = 23; most severe form, n = 2). Among the 47 patients who received the predefined therapies, 42 achieved remission within 6 months, 5 died, and 1 developed ESRD. Disease flared up in 8 of the 42 patients with remission during the 18-month follow-up period. The JMAAV trial is the first prospective trial for MPO-ANCA-associated vasculitis to be performed in Japan. The remission and death rates were comparable to those in several previous clinical trials performed in western counties. The regimen employed in this trial was tailor-made based on patients' disease severity and disease type, and it seems that standardization can be consistent with treatment choices made according to severity.
KW - Anti-neutrophil cytoplasmic antibody
KW - Microscopic polyangiitis
KW - Prophylaxis
KW - Pulmonary-limited vasculitis
KW - Severity-based treatment
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UR - http://www.scopus.com/inward/citedby.url?scp=84865392910&partnerID=8YFLogxK
U2 - 10.1007/s10165-011-0525-5
DO - 10.1007/s10165-011-0525-5
M3 - Article
C2 - 21928092
AN - SCOPUS:84865392910
SN - 1439-7595
VL - 22
SP - 394
EP - 404
JO - Modern Rheumatology
JF - Modern Rheumatology
IS - 3
ER -