title: Effectiveness and safety of tocilizumab in achieving clinical and functional remission, and sustaining efficacy in biologics-naive patients with rheumatoid arthritis: The FIRST Bio study.
abstract: OBJECTIVE
  To evaluate effectiveness and safety of tocilizumab (TCZ) in biologic-naive Japanese patients with rheumatoid arthritis (RA) in real-world settings, and to analyze the relationship between disease duration and clinical outcomes.
  
  
  METHODS
  The FIRST Bio study was a postmarketing surveillance study of intravenous TCZ in biologics-naive patients who had a prior inadequate response or were intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Effectiveness, safety, and concomitant csDMARD administration were assessed.
  
  
  RESULTS
  Of the 839 patients analyzed, 72.3% completed 52 weeks of treatment. The Clinical Disease Activity Index (CDAI) remission rate at week 52 was 36.8%. Contributing factors for CDAI remission were younger age, early disease stage, and no comorbidities. Health Assessment Questionnaire Disability Index ≤0.5 was achieved in 65.1% of patients, and was significantly associated with disease duration. Discontinuation of concomitant methotrexate (MTX) and glucocorticoids (GCs) was possible in 19.3% and 34.1% of patients, respectively, without decreasing remission rate. The incidence (events/100 patient-years) of serious adverse events was 18.09, the most common being infection.
  
  
  CONCLUSIONS
  These data validate the importance of TCZ treatment in the early stages of RA in biologic-naive patients to achieve increased effectiveness. The safety profile of TCZ was reconfirmed. Furthermore, TCZ therapy may allow discontinuation of concomitant MTX and GCs without affecting remission.
authors.affiliation: a Department of Orthopedic Surgery , Nagoya University Graduate School & Faculty of Medicine , Nagoya , Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.affiliation: b Hokkaido University Graduate School of Medicine , Sapporo , Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Atsumi
authors.affiliation: c Department of Pharmacovigilance , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.affiliation: d Department of Rheumatology and Clinical Immunology , Kyoto University , Kyoto , Japan.
authors.forename: Tsuneyo
authors.initials: T
authors.lastname: Mimori
authors.affiliation: e Osaka Rheumatology Clinic, Tokyo Medical University , Osaka , Japan.
authors.forename: Norihiro
authors.initials: N
authors.lastname: Nishimoto
authors.affiliation: f Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba , Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sumida
authors.affiliation: g Division of Rheumatology, Department of Internal Medicine , Keio University , Minato , Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: h The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health , Kitakyushu , Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: i Pharmacovigilance Department , Chugai Pharmaceutical Co. Ltd. , Tokyo , Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Nakasone
authors.affiliation: j Medical Science Department , Chugai Pharmaceutical Co. Ltd. , Tokyo , Japan , and.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Takagi
authors.affiliation: k Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D001688:Biological Products; D005938:Glucocorticoids; C502936:tocilizumab; D008727:Methotrexate
keywords: Biologics-naive; Intravenous; Rheumatoid arthritis; Tocilizumab