ARD: Tofacitinib and Risk of Cardiovascular Outcomes: Results of the Safety of Tofacitinib in Usual Care Patients with Rheumatoid Arthritis (STAR-RA) Study

Objectives: Recent results from the " ORAL Surveillance" trial have raised concerns about the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA.

Objectives: Objectives: Recent results from the " ORAL Surveillance" trial have raised concerns about the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA.

Methods Using claims databases from Optum Clinformatics ( 2012-2020 ), IBM MarketScan ( 2012-2018 ) , and Medicare ( Parts A , B , and D , 2012-2017 ) , two use cases were created using de-identified data Cohorts of RA patients treated with fatinib or a tumor necrosis factor inhibitor (TNFI) : (1) "Real World Evidence (RWE) cohort" of usual care patients and (2) Inclusion and exclusion of trials mimicking " ORAL surveillance" A standard "randomized controlled trial (RCT) -replicate cohort" trial to calibrate results to trial result.

Results In the RWE cohort, 102,263 patients were identified, of whom 12,852 ( 16% ) started tofacitin.

Conclusions This study found no evidence of an increased risk of cardiovascular outcomes in RA patients treated with tofacitinib in the real world ; however, in RA patients with cardiovascular risk factors, tofacitinib was associated with an increased risk of cardiovascular outcomes, although Not statistically significan.

Source: Khosrow-Khavar F, Kim SC, Lee H , et a.

Khosrow-Khavar F, Kim SC, Lee H , et a.
Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) stu.
Annals of the Rheumatic Diseases2022; 81: 798-80 , et al Annals of the Rheumatic Diseases81: leave a message here