RISK OF EXTENDED MAJOR ADVERSE CARDIOVASCULAR EVENT ENDPOINTS WITH TOFACITINIB VS TNF INHIBITORS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF A PHASE 3B/4 RANDOMIZED SAFETY STUDY
Authors: Paul Emery et al.
This is a detailed sub-analysis of the ORAL Surveillance study. Among others, the study found higher risk of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE) with tofacitinib versus anti-TNFi. This analysis allows to better understand the risk of individual MACE events in pts with RA. In brief,
- Tofacitinib was not associated with an increased risk of stroke or transient ischemic attacks, unstable angina pectoris, heart failure or peripheral vascular disease.
- Tofactinib was not associated with significant increase of MACE in patients with no prior history of atherosclerotic disease
- On the contrary, MACE endpoints were generally higher with tofacitinib in patients with a prior history of atherosclerotic disease
The ORAL Surveillance study has altered the way clinicians use JAK-inhibitors in the clinic. We are now advised by the Swiss health authorities to use JAK-inhibitors «only when no therapeutic alternative is appropriate in elderly patients or in patients with cardiovascular or cancer risk factors». This detailed analysis of cardiovascular outcomes allows to better understand in which patient groups caution is needed when using these therapies. In particular, JAK-inhibitors should probably be used with more caution in patients with a prior history of atherosclerotic disease.