1. Safety and effectiveness of abatacept in Japanese non-elderly and elderly patients with rheumatoid arthritis in an all-cases post-marketing surveillance.
- Author
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Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Tsuneyo Mimori, Junnosuke Ryu, Syuji Takei, Tsutomu Takeuchi, Yoshiya Tanaka, Yoshinari Takasaki, Hisashi Yamanaka, Yuri Yoshizawa, Ichino Chinen, Toru Nakao, and Takao Koike
- Subjects
ABATACEPT ,RHEUMATOID arthritis ,OLDER people ,GLUCOCORTICOIDS ,ADVERSE health care events ,METHOTREXATE - Abstract
Objectives: To investigate the safety, effectiveness, and risk-benefit balance of intravenous abatacept (ABA) in non-elderly (<65 years: NEG) and elderly (-65 years: EG) rheumatoid arthritis patients. Methods: This sub-analysis of an all-cases postmarketing surveillance in Japan assessed safety in all enrolled patients and effectiveness in those with Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) measurements at -2 time points including baseline. Risk-benefit was evaluated based on infections and DAS28-CRP improvement >1.2. Results: The NEG and EG of the safety analysis set comprised 2,170 and 1,712 patients, respectively; corresponding 6-month ABA retention rates were 80.2% and 77.1%. The NEG had fewer adverse drug reactions (14.5% vs. 17.2%, p¼.021) and infections (4.8% vs. 7.2%, p¼.002) than the EG. DAS28-CRP changed similarly between groups. The proportion of patients with low-risk/high-benefit and high-risk/low-benefit were 33.1% and 6.9% (NEG) and 29.7% and 9.0% (EG). Low-risk/high-benefit patients were younger, had shorter disease duration and fewer comorbidities, and were with less use of oral glucocorticoid and prior biologics, more use of methotrexate and higher DAS28-CRP than high-risk/lowbenefit patients at baseline. Conclusion: ABA was well tolerated and similarly efficacious in the EG and NEG. Identification of factors related to low-risk/high-benefit may aid appropriate patient selection. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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