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
Overview
- Phase
- Not Applicable
- Intervention
- Tocilizumab
- Conditions
- Infection
- Sponsor
- Sungkyunkwan University
- Enrollment
- 9508
- Locations
- 1
- Primary Endpoint
- Hazard ratio for serious infections
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ju-Young Shin
Assistant Professor
Sungkyunkwan University
Eligibility Criteria
Inclusion Criteria
- •Individuals who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) between 2013 and 2018
Exclusion Criteria
- •Individuals less than 18 years of age
- •Having no records of prescription of tocilizumab or TNFi at least once between 2013 and 2018
Arms & Interventions
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.
Intervention: Tocilizumab
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.
Intervention: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
Outcomes
Primary Outcomes
Hazard ratio for serious infections
Time Frame: January 2013 to December 2018
The ratio of the hazard rates of the serious infections in tocilizumab initiators vs. TNFi users
Secondary Outcomes
- Hazard ratio for six subdivided groups of serious infections by organ class(January 2013 to December 2018)