Dataset Information

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

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-naïve 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.

SUBMITTER: Harigai M

PROVIDER: S-EPMC4898160 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Harigai Masayoshi M Ishiguro Naoki N Inokuma Shigeko S Mimori Tsuneyo T Ryu Junnosuke J Takei Syuji S Takeuchi Tsutomu T Tanaka Yoshiya Y Takasaki Yoshinari Y Yamanaka Hisashi H Watanabe Masahiko M Tamada Hiroshi H Koike Takao T

Modern rheumatology 20160108 4

<h4>Objective</h4>To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA).<h4>Methods</h4>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 ...[more]

PMID: 26635183

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Dataset Information

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

Objective

Methods

Results

Conclusions

Publications

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

Similar Datasets

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