title: Postmarketing surveillance of the safety and effectiveness of etanercept in Japan.
abstract: OBJECTIVE
  Postmarketing surveillance (PMS) was conducted evaluating safety and effectiveness of etanercept (ETN; Enbrel) in Japan, following all patients with rheumatoid arthritis (RA) during the conditional approval period of ETN.
  
  
  METHODS
  Registration of patients from 1,334 medical sites was conducted between March 2005 and April 2007. Patients were followed for 24 weeks; data regarding patients' background, safety, and effectiveness was recorded centrally. Adverse events (AE) and adverse drug reactions (ADR) were coded using the Medical Dictionary for Regulatory Activities. Effectiveness was measured using the Disease Activity Score 28 (DAS28).
  
  
  RESULTS
  Of 14,369 patients registered, data collection and evaluation for 7,091 patients by March 2006 is reported. At least 1 AE was observed for 2,173 patients (30.6%); 60% of AE occurred within 8 weeks of starting ETN. Most frequent AE were injection site reaction (n = 377, 5.3%) and rash (n = 228, 3.2%). Serious AE occurred in 403 patients (5.7%); most frequent were pneumonia (n = 59, 0.8%) and interstitial lung disease (n = 42, 0.6%). Pneumonia was the most common specifically important ADR (n = 102, 1.4%). Mean baseline DAS28 was 6.0, which reduced to 4.4 within 4 weeks, and to 3.9 within 24 weeks. The proportion of patients having good or moderate EULAR response measured by DAS28 was 84.1% at Week 24. Effectiveness rates were more favorable in patients concomitantly using methotrexate. Good or moderate EULAR response rate among patients switched from infliximab was 84.9%.
  
  
  CONCLUSIONS
  This extensive observational trial, including all patients with RA in Japan taking ETN, found ETN to be both effective and well tolerated by Japanese patients with RA.
  
  
  BACKGROUND
  clinicaltrials.gov identifier NCT00503503.
authors.affiliation: Japan College of Rheumatology Etanercept Post-Marketing, Surveillance Committee, Wyeth K.K., Medical Affairs, Osaka, Japan.
authors.forename: Takao
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authors.lastname: Koike
authors.forename: Masayoshi
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authors.lastname: Harigai
authors.forename: Shigeko
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authors.lastname: Inokuma
authors.forename: Kazuhiko
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authors.lastname: Inoue
authors.forename: Naoki
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authors.lastname: Ishiguro
authors.forename: Junnosuke
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authors.forename: Tsutomu
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authors.lastname: Takeuchi
authors.forename: Yoshiya
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authors.lastname: Tanaka
authors.forename: Hisashi
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authors.lastname: Yamanaka
authors.forename: Koichi
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authors.lastname: Fujii
authors.forename: Bruce
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authors.lastname: Freundlich
authors.forename: Michio
authors.initials: M
authors.lastname: Suzukawa