Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGOther Biologics
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.
DRUGTocilizumab
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 or Stroke with Tocilizumab Versus Non-TNFi Therapies | 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 |
| Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS | Up to approximately 1 year from index date |
Outcome results
None listed