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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 | Japan | PMS | Rheumatoid arthritis | Safety |
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. |
Rights: | https://creativecommons.org/licenses/by-nc-nd/3.0/ |
Type: | article |
URI: | http://hdl.handle.net/2115/62616 |
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)
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Submitter: 小池 隆夫
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