| Project/Area Number |
25860390
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Applied pharmacology
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| Research Institution | Tokyo Medical and Dental University |
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Principal Investigator |
SAKAI Ryoko 東京医科歯科大学, 医歯(薬)学総合研究科, 助教 (30631981)
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| Project Period (FY) |
2013-04-01 – 2015-03-31
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| Project Status |
Completed (Fiscal Year 2014)
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| Budget Amount *help |
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2014: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2013: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
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| Keywords | 薬剤疫学 / 関節リウマチ / 分子標的薬 / 安全性 / 感染症 / 合併症 / 生物学的製剤 / レジストリ / 保険データベース / レジストリー / 前向きコホート研究 / 抗リウマチ薬 |
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| Outline of Final Research Achievements |
We assessed the risk for serious adverse events (SAE) and serious infections (SI) during first year of the treatment in patients with RA starting tocilizumab or TNF inhibitor using the REAL. The multivariate analysis revealed that treatment with TCZ was not associated with higher risk for SAE [hazard ratio (HR) 1.3, 95% CI 0.8-2.2] or SI (HR 2.2, 95% CI 0.9-5.4).
In the REAL, we evaluated effect of disease duration on safety of biologics in patients with RA. The multivariate analysis showed that HR (long-standing RA vs. early RA) was not significantly associated with SI (HR 1.2 [0.7-2.3]).
We compared the prevalence of comorbidities between RA cases and non-RA cases using Japanese health insurance database. We found that prevalence of all the investigated comorbidities in the RA group was significantly higher compared to the non-RA group and that RA was significantly associated with cardiovascular comorbidities after adjusting for covariates.
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