Kaori Watanabe-Imai1,2, Masayoshi Harigai1,2, Ken-Ei Sada3, Masahiro Yamamura4, Takao Fujii5, Hiroaki Dobashi6, Koichi Amano7, Satoshi Ito8, Sakae Homma9, Shunichi Kumagai10, Shogo Banno11, Yoshihiro Arimura12, Hirofumi Makino13. 1. a Department of Pharmacovigilance. 2. b Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical Dental University , Bunkyo-ku , Tokyo , Japan. 3. c Department of Nephrology, Rheumatology, Endocrinology and Metabolism , Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences , Kita-ku , Okayama , Japan. 4. d Centor for Rheumatology, Okayama Saiseikai Hospital , Kita-ku , Okayama , Japan. 5. e Department of the Control for Rheumatic Diseases , Graduate School of Medicine, Kyoto University , Kyoto , Japan. 6. f Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine , Kagawa University , Kida-gun , Kagawa , Japan. 7. g Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Kawagoe, Saitama , Japan. 8. h Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba , Ibaraki , Japan. 9. i Department of Respiratory Medicine , Toho University Omori Medical Center , Ota-ku , Tokyo , Japan. 10. j Department of Clinical Pathology and Immunology, Graduate School of Medicine , Kobe University , Kobe , Hyogo , Japan. 11. k Division of Rheumatology and Nephrology , Aichi Medical University School of Medicine , Nagakute , Aichi , Japan. 12. l Nephrology and Rheumatology, First Department of Internal Medicine , Kyorin University School of Medicine , Mitaka, Tokyo , Japan , and. 13. m Okayama University Hospital , Kita-ku, Okayama , Japan.
Abstract
OBJECTIVES: The purpose of this study was to identify the clinical characteristics and predictors of serious infections (SIs) in the RemIT-JAV, a nationwide, prospective, inception cohort study for Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). METHODS: We analyzed SIs within six months of remission induction therapy in 156 AAV patients. Hazard ratios with 95% confidence intervals (CIs) for SIs were calculated using the COX proportional hazard model. RESULTS: Sixty-three SIs in 42 patients were identified. The incidence rate (IR) of SIs was 87.59/100 patient-years. The median length of time to the onset of first SIs was 54 days. Hazard ratios (95%CI) for SIs were 1.97 (0.99-3.95) for age >65 years, 0.47 (0.25-0.89) for female sex, 2.11 (1.05-4.27) for the severe form of AAV, and 2.88 (1.49-5.88) for initial PSL >0.8 mg/kg/day in the first model, and 2.64 (1.39-5.01) for smoking and 3.27 (1.66-6.45) for initial PSL >0.8 mg/kg/day in the second model. CONCLUSIONS: Lowering the IR of SIs in Japanese AAV patients is mandatory to improve the vital prognosis of these patients. For remission induction therapy of AAV patients with these risk factors, risk management of immunosuppressive treatment should be carefully considered.
OBJECTIVES: The purpose of this study was to identify the clinical characteristics and predictors of serious infections (SIs) in the RemIT-JAV, a nationwide, prospective, inception cohort study for Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). METHODS: We analyzed SIs within six months of remission induction therapy in 156 AAV patients. Hazard ratios with 95% confidence intervals (CIs) for SIs were calculated using the COX proportional hazard model. RESULTS: Sixty-three SIs in 42 patients were identified. The incidence rate (IR) of SIs was 87.59/100 patient-years. The median length of time to the onset of first SIs was 54 days. Hazard ratios (95%CI) for SIs were 1.97 (0.99-3.95) for age >65 years, 0.47 (0.25-0.89) for female sex, 2.11 (1.05-4.27) for the severe form of AAV, and 2.88 (1.49-5.88) for initial PSL >0.8 mg/kg/day in the first model, and 2.64 (1.39-5.01) for smoking and 3.27 (1.66-6.45) for initial PSL >0.8 mg/kg/day in the second model. CONCLUSIONS: Lowering the IR of SIs in Japanese AAV patients is mandatory to improve the vital prognosis of these patients. For remission induction therapy of AAV patients with these risk factors, risk management of immunosuppressive treatment should be carefully considered.