Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme

Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-223406 Epub ahead of print

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

ORAL Surveillance found that patients with RA aged ≥50 years with ≥1 additional CV risk factor had an increased risk of major adverse cardiovascular events (MACE) with tofacitinib vs TNFi. However, excess risk of MACE was not identified in the wider tofacitinib RA clinical trial programme. To help better understand the results from ORAL Surveillance versus the tofacitinib clinical trial programme, Dougados, et al. assess MACE incidence rates in all patients, and separately in patients with and without history of ASCVD, providing important context regarding the CV safety of tofacitinib in patients without a history of ASCVD.