Etanercept (one of the Biological Products, Tumor Necrosis Factor (TNF) Inhibitor) is one of the drugs with reinforced control by the Bureau of National Health Insurance (BNHI). The criteria for its usage are very restricted and need a special application. In spite of all this bondages, BNHI medication expense of 2009 still was 7.4 hundred millions in this single drug. The medication expenses are not the most resource consumed item caused by the medication treatment. The expenses caused by medication related diseases and death increased from 766 millions to 1,774 millions (US Dollars) within 5 years. Therefore, to understand and prevent the medication related diseases and death is an urgent and important issue. In a retrospective review of domestic and foreign researches, there are mainly effective researches for the expanding of the medication use market. Research designed to discuss drug safety are few, without mentioning research that discuss the adverse drug event related to malignancies. Once malignancies occurs, it also brings out a lot of personal, familial, social problems, and the problems will not end while withdrawing the causing drugs, the expenses are high. There is an urgent demand to discuss about this issue. The current study discusses the risk of increasing the adverse drug event related to malignancies in the treatment of rheumatoid arthritis using TNF-alpha inhibitors. In the other hand, comparison of the risk difference between two TNF-alpha inhibitors for rheumatoid arthritis approved by BNHI will also be realized. The current study is a cohort study, analyzing the Longitudinal Health Insurance Database 2010 (LHID2010) from 2003 through 2011. Besides the analysis with 2-tailed t tests and χ2 tests, during the follow up period, the total drug exposure time will be also calculated. By using Cox proportional hazards model, the current study also will compare the difference of time-to-event between the adverse drug events occurred in two groups and its risk ratios (RR) and the 95% confidence interval, (CIs).
|Effective start/end date||8/1/13 → 7/31/14|
- Tumor Necrosis Factor-alpha Inhibitor
- National Health Insurance Research Database
- rheumatoid arthritis