title: Clinical characteristics of and risk factors for serious infection in Japanese patients within six months of remission induction therapy for antineutrophil cytoplasmic antibody-associated vasculitis registered in a nationwide, prospective, inception cohort study.
abstract: OBJECTIVE
  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.
authors.affiliation: a Department of Pharmacovigilance.|b Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical Dental University , Bunkyo-ku , Tokyo , Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Watanabe-Imai
authors.affiliation: a Department of Pharmacovigilance.|b Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical Dental University , Bunkyo-ku , Tokyo , Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.affiliation: c Department of Nephrology, Rheumatology, Endocrinology and Metabolism , Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences , Kita-ku , Okayama , Japan.
authors.forename: Ken-Ei
authors.initials: KE
authors.lastname: Sada
authors.affiliation: d Centor for Rheumatology, Okayama Saiseikai Hospital , Kita-ku , Okayama , Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yamamura
authors.affiliation: e Department of the Control for Rheumatic Diseases , Graduate School of Medicine, Kyoto University , Kyoto , Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Fujii
authors.affiliation: f Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine , Kagawa University , Kida-gun , Kagawa , Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Dobashi
authors.affiliation: g Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Kawagoe, Saitama , Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Amano
authors.affiliation: h Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba , Ibaraki , Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ito
authors.affiliation: i Department of Respiratory Medicine , Toho University Omori Medical Center , Ota-ku , Tokyo , Japan.
authors.forename: Sakae
authors.initials: S
authors.lastname: Homma
authors.affiliation: j Department of Clinical Pathology and Immunology, Graduate School of Medicine , Kobe University , Kobe , Hyogo , Japan.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Kumagai
authors.affiliation: k Division of Rheumatology and Nephrology , Aichi Medical University School of Medicine , Nagakute , Aichi , Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Banno
authors.affiliation: l Nephrology and Rheumatology, First Department of Internal Medicine , Kyorin University School of Medicine , Mitaka, Tokyo , Japan , and.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Arimura
authors.affiliation: m Okayama University Hospital , Kita-ku, Okayama , Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Makino
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D056648:Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / Q000188:drug therapy*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015994:Incidence; D007239:Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012042:Registries; D012074:Remission Induction; D012307:Risk Factors; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents
keywords: Antineutrophil cytoplasmic antibody-associated vasculitis; Corticosteroid; Inception cohort study; Risk factors; Safety; Serious infection