Rheumatoid Arthritis
Conditions
Brief summary
There are two main aims of this study. First aim is to compare the risk of cardiovascular events (including myocardial infarction or stroke), between patients treated with tofacitinib and patients treated with TNF inhibitors (TNFi) for rheumatoid arthritis (RA) among, 1) real world evidence (RWE) cohorts including routine care patient population from the US and, 2) Randomized controlled trial (RCT) DUPLICATE cohorts including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis (ORAL Surveillance, NCT02092467) clinical trial. Second aim is to examine the risk of myocardial infarction, stroke, heart failure hospitalization, coronary revascularization, and all-cause mortality as separate endpoints when comparing tofacitinib with TNFi in patients with RA among, 1) real world evidence (RWE) cohort including routine care patient population from the US and, 2) Randomized controlled trial (RCT) DUPLICATE cohort including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis (ORAL Surveillance, NCT02092467) clinical trial.
Interventions
DRUGTofacitinib
First eligible prescription for treating rheumatoid arthritis (RA)
DRUGTNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria: Please see https://www.bwhprime.org/resources.html for full code and algorithm definitions. Eligible cohort entry dates: * For US MarketScan, 2012-2018 * For Optum, 2012-2020 * For Medicare Claims Database (Parts A, B and D), 2012-2017 Cohort entry date: * First TNFi or tofacitinib dispensation/administration date Inclusion and
Exclusion criteria
Common to RWE and RCT-duplicate Cohorts: 1. Inclusion Criteria * Patients treated with tofacitinib or TNF inhibitors in IBM MarketScan, Optum, and Medicare fee-for-service * A minimum of 365 days of continuous enrollment in health plan prior to (and including) the cohort entry date * Two diagnosis codes for RA in any setting in 365 days baseline period (diagnosis codes between 7 and 365 days apart) 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke | Through study time period (2012-2020) | Myocardial infarction OR Stroke |
Secondary
| Measure | Time frame |
|---|---|
| Time to myocardial infarction | Through study time period (2012-2020) |
| Time to stroke | Through study time period (2012-2020) |
| Time to heart failure hospitalization | Through study time period (2012-2020) |
| Time to coronary revascularization | Through study time period (2012-2020) |
| Time to all-cause mortality | Through study time period (2012-2020) |
Countries
United States
Outcome results
None listed