Postmarketing surveillance of the safety and effectiveness of etanercept in Japan

Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Kazuhiko Inoue, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Koichi Fujii, Bruce Freundlich, Michio Suzukawa

研究成果: Article査読

130 被引用数 (Scopus)

抄録

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%. Conclusion. 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. Trial registration: clinicaltrials.gov identifier NCT00503503. The Journal of Rheumatology

本文言語English
ページ(範囲)898-906
ページ数9
ジャーナルJournal of Rheumatology
36
5
DOI
出版ステータスPublished - 2009 5
外部発表はい

ASJC Scopus subject areas

  • リウマチ学
  • 免疫アレルギー学
  • 免疫学

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