A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

• Conditions: Infection; Rheumatoid Arthritis
• Interventions: Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab); Drug: Tocilizumab

• Registration Number: NCT04115423
• Lead Sponsor: Sungkyunkwan University

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.

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Study Start: 2020-04-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9508

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumor necrosis factor inhibitors (TNFi) users	Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)	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.
Tocilizumab initiators	Tocilizumab	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.

Primary Outcome Measures

Name	Time	Method
Hazard ratio for serious infections	January 2013 to December 2018	The ratio of the hazard rates of the serious infections in tocilizumab initiators vs. TNFi users

Secondary Outcome Measures

Name	Time	Method
Hazard ratio for six subdivided groups of serious infections by organ class	January 2013 to December 2018	The ratio of the hazard rates of six subdivided organ-specific serious infections (respiratory tract, gastrointestinal tract, urological and gynecological infections, skin and subcutaneous tissue, sepsis, and others) in tocilizumab initiators vs. TNFi users

Trial Locations

Locations (1)

Sungkyunkwan University; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of