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

Hoffmann-La Roche48,950 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

48,950

Conditions

Rheumatoid Arthritis

Interventions

Other BiologicsDRUG

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.

TocilizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies