A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)

Study Overview
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Brief Summary
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This retrospective cohort study will analyze data from multiple large U.S. health insurance claims databases to compare use of tocilizumab to other biologic disease-modifying anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing as the index date, the analysis will compute the time to first event for several cardiovascular outcomes.

Official Title
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Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Other Biologics
* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 1 inpatient or 2 outpatient diagnoses of RA Continuous medical/pharmacy coverage and full claims data available At least 6 months of insurance plan enrollment prior to index date Exclusion Criteria: Nursing home residents Human immunodeficiency virus (HIV) Malignancy Receipt of chemotherapy End-stage renal disease, dialysis, or transplant Use of rituximab Recent cardiovascular event (includes MI, stroke, ACS, or HF) within 90 days prior to index date

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-TNFi Biologics<br>Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included. | Drug: Other Biologics<br>* Exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. There are no protocol-specified biologic agents, although the analyses will be stratified by TNFi and non-TNFi targeted therapies. The drug selection and regimen are at the discretion of the prescribing physician.<br>|
| TNFi Biologics<br>Real world patients with RA with a dispensing history for TNFi biologics will be included. | Drug: Other Biologics<br>* Exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. There are no protocol-specified biologic agents, although the analyses will be stratified by TNFi and non-TNFi targeted therapies. The drug selection and regimen are at the discretion of the prescribing physician.<br>|
| Tocilizumab<br>Real world patients with RA with a dispensing history for tocilizumab will be included. | Drug: Tocilizumab<br>* Tocilizumab exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. The regimen is at the discretion of the prescribing physician.<br>* Other names: Actemra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies |  | Up to approximately 1 year from index date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies |  | Up to approximately 1 year from index date | 
| Time to Hospitalization for Coronary Revascularization Procedure |  | Up to approximately 1 year from index date | 
| Time to Hospitalization for Acute Coronary Syndrome (ACS) |  | Up to approximately 1 year from index date | 
| Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS |  | Up to approximately 1 year from index date | 
| Time to Heart Failure (HF) Requiring Hospitalization |  | Up to approximately 1 year from index date | 
| Time to All-Cause Death |  | Up to approximately 1 year from index date |