A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database
试验速览
- 阶段
- 不适用
- 入组人数
- 9,508
- 试验地点
- 1
- 主要终点
- Hazard ratio for serious infections
研究概览
简要总结
The purpose of this study is to evaluate whether the risk of serious infections in rheumatoid arthritis patients with tocilizumab is higher than in those with tumor necrosis factor inhibitors using the nationwide real-world data.
详细描述
This observational, retrospective cohort study using the Korean National Health Insurance (NHI) data will evaluate whether the risk of serious infections (SIs) in rheumatoid arthritis patients treated with tocilizumab is higher than in those with tumor necrosis factor inhibitors. We will compare incidence rates between two groups and estimate relative risks of SIs in tocilizumab users using the time-dependent Cox proportional hazard regression. Various covariates potentially related to RA severity and occurrence of infection will be assessed and used for adjustment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) between 2013 and 2018
排除标准
- •Individuals less than 18 years of age
- •Having no records of prescription of tocilizumab or TNFi at least once between 2013 and 2018
研究组 & 干预措施
Tocilizumab initiators
Patients over 18 years of age with a diagnosis of RA (ICD-10 codes: M05-06) and receiving tocilizumab at least once from January 2013 to December 2018. Tocilizumab initiators are required to have no record of tocilizumab within 1 year prior to the first prescription of tocilizumab.
干预措施: Tocilizumab (Drug)
Tumor necrosis factor inhibitors (TNFi) users
Patients over 18 years of age with a diagnosis of RA (ICD-10 codes: M05-06) and receiving TNFi at least once from January 2013 to December 2018. TNFi users will be patients who had no record of tocilizumab and given specific TNFi during 1 year before the first prescription of TNFi.
干预措施: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab) (Drug)
结局指标
主要结局
Hazard ratio for serious infections
时间窗: January 2013 to December 2018
The ratio of the hazard rates of the serious infections in tocilizumab initiators vs. TNFi users
次要结局
- Hazard ratio for six subdivided groups of serious infections by organ class(January 2013 to December 2018)
研究者
Ju-Young Shin
Assistant Professor
Sungkyunkwan University