Nitta Kosaku
   Department   Other, Other
   Position  
Article types Original article
Language English
Peer review Non peer reviewed
Title The efficacy and safety of mizoribine for maintenance therapy in patients with myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA)-associated vasculitis: the usefulness of serum mizoribine monitoring.
Journal Formal name:Clinical and experimental nephrology
Abbreviation:Clin Exp Nephrol
ISSN code:14377799/13421751
Volume, Issue, Page 26(11),pp.1092-1099
Author and coauthor Mase Kaori, Saito Chie, Usui Joichi, Arimura Yoshihiro, Nitta Kosaku, Wada Takashi, Makino Hirofumi, Muso Eri, Hirawa Nobuhito, Kobayashi Masaki, Yumura Wako, Fujimoto Shouichi, Nakagawa Naoki, Ito Takafumi, Yuzawa Yukio, Matsuo Seiichi, Yamagata Kunihiro
Publication date 2022/11
Summary BACKGROUND:The life prognosis of elderly patients with myeloperoxidase-anti-neutrophil cytoplasmic antibodies-associated vasculitis (MPO-AAV) has been improved by reducing the corticosteroid or cyclophosphamide dose to avoid opportunistic infection. However, many elderly MPO-AAV patients experience recurrence and renal death. An effective and safer maintenance treatment method is necessary to improve the renal prognosis of MPO-AAV.METHODS:Patients with MPO-AAV who reached complete or incomplete remission after induction therapy were prospectively and randomly divided into mizoribine (MZR; n = 25) and control (n = 28) groups. The primary endpoint was relapse of MPO-AAV. The patients' serum MZR concentration was measured before (C0) and 3 h after taking the MZR. The maximum drug concentration (Cmax) and the serum MZR concentration curves were determined using population pharmacokinetics parameters. We also assessed the relationship between the MZR concentrations and adverse events. The observation period was 12 months.RESULTS:Fifty-eight MPO-AAV patients from 16 hospitals in Japan were enrolled. Ten patients relapsed (MZR group, n = 6; control group, n = 4; a nonsignificant between-group difference). Changes in the serum MZR concentration could be estimated for 22 of the 25 MZR-treated patients: 2 of the 11 patients who reached a Cmax of 3 μg/mL relapsed, whereas 4 of the 11 patients who did not reach this Cmax relapsed. The treatment of one patient with C0 > 1 μg/mL was discontinued due to adverse events. No serious adverse events occurred.CONCLUSION:There was no significant difference in the recurrence rate of MPO-AAV between treatment with versus without MZR.
DOI 10.1007/s10157-022-02253-6
PMID 35908130