Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis

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

Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis

Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko et al.

Modern Rheumatology, 2011, 21(4), 343-351

Permalink : https://hdl.handle.net/2115/62836

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アクセス権	open access
URI	https://hdl.handle.net/2115/62836
タイトル	Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis
著者	Koike, Takao ; Harigai, Masayoshi ; Inokuma, Shigeko ; Ishiguro, Naoki ; Ryu, Junnosuke ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Yamanaka, Hisashi ; Fujii, Koichi ; Yoshinaga, Takunari ; Freundlich, Bruce ; Suzukawa, Michio
e-Rad_Researcher 80146795 著者名 Koike, Takao
e-Rad_Researcher 20238207 著者名 Harigai, Masayoshi
著者名 Inokuma, Shigeko
e-Rad_Researcher 20212871 著者名 Ishiguro, Naoki
e-Rad_Researcher 30096854 著者名 Ryu, Junnosuke
e-Rad_Researcher 50179610 著者名 Takeuchi, Tsutomu
e-Rad_Researcher 30248562 著者名 Tanaka, Yoshiya
e-Rad_Researcher 10166754 著者名 Yamanaka, Hisashi
著者名 Fujii, Koichi
著者名 Yoshinaga, Takunari
著者名 Freundlich, Bruce
著者名 Suzukawa, Michio
言語	英語
キーワード	DAS28
	Etanercept
	Postmarketing surveillance study
	Rheumatoid arthritis
発行日	2011
出版者	Springer
収録物名	Modern Rheumatology
巻(号)	21(4)
ページ	343-351
抄録	Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p < 0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p < 0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
権利情報	Creative Commons Attribution 3.0 Unported
PISSN	1439-7595
NCID	AA1157187X
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.1007/s10165-010-0406-3