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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105711 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients treated with Tofacitinib

Real-World Evidence (RWE) and RCT-Duplicate

Tofacitinib

Intervention Type DRUG

First eligible prescription for treating rheumatoid arthritis (RA)

Patients treated with TNF inhibitors

Real-World Evidence (RWE) and RCT-Duplicate

TNF Inhibitor

Intervention Type DRUG

First eligible prescription for treating rheumatoid arthritis (RA)

Interventions

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Tofacitinib

First eligible prescription for treating rheumatoid arthritis (RA)

Intervention Type DRUG

TNF Inhibitor

First eligible prescription for treating rheumatoid arthritis (RA)

Intervention Type DRUG

Other Intervention Names

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infliximab adalimumab certolizumab pegol etanercept golimumab

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)

* 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

* 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)

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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No