PMID- 27538706 OWN - NLM STAT- MEDLINE DCOM- 20180326 LR - 20191210 IS - 1439-7609 (Electronic) IS - 1439-7595 (Linking) VI - 27 IP - 4 DP - 2017 Jul TI - 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. PG - 646-651 LID - 10.1080/14397595.2016.1226468 [doi] AB - 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. FAU - Watanabe-Imai, Kaori AU - Watanabe-Imai K AD - a Department of Pharmacovigilance. AD - b Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical Dental University , Bunkyo-ku , Tokyo , Japan. FAU - Harigai, Masayoshi AU - Harigai M AD - a Department of Pharmacovigilance. AD - b Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical Dental University , Bunkyo-ku , Tokyo , Japan. FAU - Sada, Ken-Ei AU - Sada KE AD - c Department of Nephrology, Rheumatology, Endocrinology and Metabolism , Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences , Kita-ku , Okayama , Japan. FAU - Yamamura, Masahiro AU - Yamamura M AD - d Centor for Rheumatology, Okayama Saiseikai Hospital , Kita-ku , Okayama , Japan. FAU - Fujii, Takao AU - Fujii T AD - e Department of the Control for Rheumatic Diseases , Graduate School of Medicine, Kyoto University , Kyoto , Japan. FAU - Dobashi, Hiroaki AU - Dobashi H AD - f Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine , Kagawa University , Kida-gun , Kagawa , Japan. FAU - Amano, Koichi AU - Amano K AD - g Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Kawagoe, Saitama , Japan. FAU - Ito, Satoshi AU - Ito S AD - h Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba , Ibaraki , Japan. FAU - Homma, Sakae AU - Homma S AD - i Department of Respiratory Medicine , Toho University Omori Medical Center , Ota-ku , Tokyo , Japan. FAU - Kumagai, Shunichi AU - Kumagai S AD - j Department of Clinical Pathology and Immunology, Graduate School of Medicine , Kobe University , Kobe , Hyogo , Japan. FAU - Banno, Shogo AU - Banno S AD - k Division of Rheumatology and Nephrology , Aichi Medical University School of Medicine , Nagakute , Aichi , Japan. FAU - Arimura, Yoshihiro AU - Arimura Y AD - l Nephrology and Rheumatology, First Department of Internal Medicine , Kyorin University School of Medicine , Mitaka, Tokyo , Japan , and. FAU - Makino, Hirofumi AU - Makino H AD - m Okayama University Hospital , Kita-ku, Okayama , Japan. CN - Research Committee on Intractable Vasculitides, the Ministry of Health, Labor and Welfare of Japan LA - eng PT - Journal Article DEP - 20161010 PL - England TA - Mod Rheumatol JT - Modern rheumatology JID - 100959226 RN - 0 (Immunosuppressive Agents) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/*drug therapy MH - Cohort Studies MH - Female MH - Humans MH - Immunosuppressive Agents/*adverse effects/therapeutic use MH - Incidence MH - Infections/*diagnosis/epidemiology/etiology MH - Male MH - Middle Aged MH - Prognosis MH - Prospective Studies MH - Registries MH - Remission Induction MH - Risk Factors MH - Young Adult OTO - NOTNLM OT - Antineutrophil cytoplasmic antibody-associated vasculitis OT - Corticosteroid OT - Inception cohort study OT - Risk factors OT - Safety OT - Serious infection EDAT- 2016/08/20 06:00 MHDA- 2018/03/27 06:00 CRDT- 2016/08/20 06:00 PHST- 2016/08/20 06:00 [pubmed] PHST- 2018/03/27 06:00 [medline] PHST- 2016/08/20 06:00 [entrez] AID - 10.1080/14397595.2016.1226468 [doi] PST - ppublish SO - Mod Rheumatol. 2017 Jul;27(4):646-651. doi: 10.1080/14397595.2016.1226468. Epub 2016 Oct 10.