title: Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis.
abstract: OBJECTIVE
  To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA).
  
  
  METHODS
  Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations.
  
  
  RESULTS
  Overall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved significantly over 6 months. Separate multivariate analysis identified predictors of severe ADR, and severe infections and factors predictive of clinically meaningful DAS28 improvement after 6 months of treatment with abatacept.
  
  
  CONCLUSIONS
  Abatacept was efficacious and well tolerated in a clinical setting. No new safety concerns were detected.
authors.affiliation: a 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: b Graduate School & Faculty of Medicine , Nagoya University , Nagoya , Japan .
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.affiliation: c Chiba Central Medical Center , Chiba , Japan .
authors.forename: Shigeko
authors.initials: S
authors.lastname: Inokuma
authors.affiliation: d Kyoto University Graduate School of Medicine , Kyoto , Japan .
authors.forename: Tsuneyo
authors.initials: T
authors.lastname: Mimori
authors.affiliation: e Nihon University School of Medicine , Tokyo , Japan .
authors.forename: Junnosuke
authors.initials: J
authors.lastname: Ryu
authors.affiliation: f Faculty of Medicine, School of Health Sciences , Kagoshima University , Kagoshima , Japan .
authors.forename: Syuji
authors.initials: S
authors.lastname: Takei
authors.affiliation: g Keio University School of Medicine , Tokyo , Japan .
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: h University of Occupational and Environmental Health , Fukuoka , Japan .
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: i Juntendo University School of Medicine , Tokyo , Japan .
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Takasaki
authors.affiliation: j Tokyo Women's Medical University , Tokyo , Japan .
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.affiliation: k Bristol-Myers K.K. , Tokyo , Japan .
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: k Bristol-Myers K.K. , Tokyo , Japan .
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tamada
authors.affiliation: l NTT Sapporo Medical Center Minami , Sapporo , Japan , and.|m Hokkaido University Graduate School of Medicine , Sapporo , Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
mesh_terms: D000069594:Abatacept / Q000009:adverse effects* / Q000627:therapeutic use; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001799:Blood Sedimentation; D002097:C-Reactive Protein; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069594:Abatacept; D002097:C-Reactive Protein
keywords: Abatacept; Japan; PMS; Rheumatoid arthritis; Safety