Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints

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:

• 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)
• Exclusion Criteria

• Index drug in 365 days prior to cohort entry date (prevalent users)
• Missing data on age or gender
• Admission to nursing facility or hospice on or prior to cohort entry date (ever look-back)
• TNFi users with history of any Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib, or baricitinib) (ever look-back period)
• TNFi users initiating with more than one TNFi on same date
• Tofacitinib users with a prescription of baricitinib, upadacitinib (ever look-back period)
• Tofacitinib users initiating treatment on multiple JAK inhibitors on same day (tofacitinib and baricitinib, tofacitinib and upadacitinib)

Exclusion criteria

specific to RWE cohorts:

• Patients less than 18 years of age (MarketScan and Optum) and 65 years of age (Medicare) at cohort entry

Inclusion criteria

specific to RCT-duplicate cohorts:

• Patients with at least one methotrexate dispensation (six months look-back period)
• Patients with at least one cardiovascular risk factor (including smoking, hypertension, dyslipidemia, diabetes mellitus, ischemic heart disease, family history of ischemic heart disease) (one-year look-back period)

Exclusion criteria

specific to RCT-duplicate cohorts:

• Patients less than 50 years of age (MarketScan and Optum) and 65 years
• Patients recently hospitalized with infections (30-day look-back period)
• Pregnant patients (one year look-back period)