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

Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Tsuneyo Mimori, Junnosuke Ryu, Syuji Takei, Tsutomu Takeuchi, Yoshiya Tanaka, Yoshinari Takasaki, Hisashi Yamanaka, Masahiko Watanabe, Hiroshi Tamada, Takao Koike

Research output: Contribution to journalArticle

34 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2016 Jan 6

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Rheumatoid Arthritis
Safety
Drug-Related Side Effects and Adverse Reactions
Product Labeling
Bacterial Pneumonia
Blood Sedimentation
Infection
C-Reactive Protein
Abatacept
Blood Proteins
Multivariate Analysis
Incidence
Therapeutics

Keywords

  • Abatacept
  • Japan
  • PMS
  • Rheumatoid arthritis
  • Safety

ASJC Scopus subject areas

  • Rheumatology

Cite this

Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis. / Harigai, Masayoshi; Ishiguro, Naoki; Inokuma, Shigeko; Mimori, Tsuneyo; Ryu, Junnosuke; Takei, Syuji; Takeuchi, Tsutomu; Tanaka, Yoshiya; Takasaki, Yoshinari; Yamanaka, Hisashi; Watanabe, Masahiko; Tamada, Hiroshi; Koike, Takao.

In: Modern Rheumatology, 06.01.2016, p. 1-8.

Research output: Contribution to journalArticle

Harigai, M, Ishiguro, N, Inokuma, S, Mimori, T, Ryu, J, Takei, S, Takeuchi, T, Tanaka, Y, Takasaki, Y, Yamanaka, H, Watanabe, M, Tamada, H & Koike, T 2016, 'Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis', Modern Rheumatology, pp. 1-8. https://doi.org/10.3109/14397595.2015.1123211
Harigai, Masayoshi ; Ishiguro, Naoki ; Inokuma, Shigeko ; Mimori, Tsuneyo ; Ryu, Junnosuke ; Takei, Syuji ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Takasaki, Yoshinari ; Yamanaka, Hisashi ; Watanabe, Masahiko ; Tamada, Hiroshi ; Koike, Takao. / Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis. In: Modern Rheumatology. 2016 ; pp. 1-8.
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