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

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Title: Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis
Authors: Harigai, Masayoshi Browse this author →KAKEN DB
Ishiguro, Naoki Browse this author →KAKEN DB
Inokuma, Shigeko Browse this author
Mimori, Tsuneyo Browse this author →KAKEN DB
Ryu, Junnosuke Browse this author →KAKEN DB
Takei, Syuji Browse this author
Takeuchi, Tsutomu Browse this author →KAKEN DB
Tanaka, Yoshiya Browse this author →KAKEN DB
Takasaki, Yoshinari Browse this author →KAKEN DB
Yamanaka, Hisashi Browse this author →KAKEN DB
Watanabe, Masahiko Browse this author
Tamada, Hiroshi Browse this author
Koike, Takao Browse this author →KAKEN DB
Keywords: Abatacept
Rheumatoid arthritis
Issue Date: 2016
Publisher: Taylor & Francis
Journal Title: Modern rheumatology
Volume: 26
Issue: 4
Start Page: 491
End Page: 498
Publisher DOI: 10.3109/14397595.2015.1123211
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-naive 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.
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

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