ASSOCIATION BETWEEN BASELINE CARDIOVASCULAR RISK AND INCIDENCE RATES OF MAJOR ADVERSE CARDIOVASCULAR EVENTS AND MALIGNANCIES IN PATIENTS WITH PSORIATIC ARTHRITIS AND PSORIASIS RECEIVING TOFACITINIB
Authors: Kristensen LE et al
The goal of the present analysis was to study baseline CV risk and metabolic syndrome and their association with MACE (major adverse cardiovascular events) and malignancies. Data from tofacitinib studies from the Phase 3 clinical trial program for PsA (n= 783) and PsO (n= 3663) were analysed. Exposures were 2038 PY for PsA and 8950 PY for PsO and the median duration of exposure was 3 years for PsA and 2.4 years for PsO. At baseline, 40.9% of PsA and 32.7% of PsO patients had a metabolic syndrome. A history of coronary artery disease was recorded in 5 and 2.5%. The incidence rate of MACE was highest in patients with PsA and PsO with baseline history of coronary artery disease and a high baseline 10-years atherosclerosis risk profile. Malignancies occurred more frequently in patients with a higher cardiovascular risk profile.
Is it the disease, the comorbidities, a specific drug or drug class? A significant number of ab-stracts at this year’s EULAR are dealing with these questions. Therefore it is of interest to analyse PsA and PsO data from the clinical phase 3 trial program with tofacitinib with a specific focus on this aspect. The findings that a higher cardiovascular risk at baseline is associated with an increased risk for MACE and malignancies seems to be similar to the conclusions drawn from the ORAL SURVEILLANCE study. In conclusion, cardiovascular risk should be assessed and monitored in PsA patients and patients be monitored for malignancies. These data suggest that cautious use of tofacitinib in PsA and PsO patients with additional CV risk factors seems warranted.