Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long-Term Extension Studies of Tofacitinib in Patients with Rheumatoid Arthritis
Christina Charles-Schoeman, Ryan DeMasi, Hernan Valdez, Koshika Soma, Lie-Ju Hwang, Mary G Boy, Pinaki Biswas, Iain B McInnes. - Arthritis Rheumatol .2019 Sep;71(9):1450-1459. doi: 10.1002/art.40911. Epub 2019 Aug 6.
Post hoc analyses of the six ORAL studies and two LTE’s suggested that after 24 weeks of TOF treatment, increases in HDL-c and decreases in the TC/HDL-c ratio appeared to be associated with reduced future MACE risk in RA patients.
52 MACE occurred in 4076 patients over 12873 patient-years of exposure. Separate Cox regression models were used to evaluate traditional CV risk factors’ association with time to first MACE at baseline and changes in lipid levels with time to future MACE after 24 weeks of TOF treatment. Patients included in the analyses received ≥1 dose of TOF and had exposure after Wk24. MACE events were independently adjudicated by the CV safety event adjudication committee.
At baseline, traditional CV risk factors were associated with increased risk of MACE however, there was no association with disease activity or inflammation measures. After 24 weeks of treatment; HDL-c increases and TC/HDL-c decreases were associated with decreased MACE risk, changes in TC, LDL-c, and disease activity measures were not.