Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-TNFi Biologics | Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included. |
| |
| TNFi Biologics | Real world patients with RA with a dispensing history for TNFi biologics will be included. |
| |
| Tocilizumab | Real world patients with RA with a dispensing history for tocilizumab will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other Biologics | Drug | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Real world patients with RA who received tocilizumab or other biologic therapy will be included. Data will be collected from multiple large U.S. health insurance claims databases in this retrospective cohort analysis.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29673963 | Result | Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, Schneeweiss S. No difference in cardiovascular risk of tocilizumab versus abatacept for rheumatoid arthritis: A multi-database cohort study. Semin Arthritis Rheum. 2018 Dec;48(3):399-405. doi: 10.1016/j.semarthrit.2018.03.012. Epub 2018 Mar 22. | |
| 28245350 | Result |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tocilizumab | Drug | 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. |
|
|
| 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 |
| Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, Schneeweiss S. Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients With Rheumatoid Arthritis: A Multi-Database Cohort Study. Arthritis Rheumatol. 2017 Jun;69(6):1154-1164. doi: 10.1002/art.40084. Epub 2017 Apr 28. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |