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Objective  Tofacitinib is an oral  JAK  inhibitor for the treatment of rheumatoid arthritis ( RA ). This study was undertaken to evaluate the risk of major adverse cardiovascular events ( MACE ) in patients with  RA  receiving tofacitinib.    Methods  Data were pooled from patients with moderately to severely active  RA  receiving ≥1 tofacitinib dose in 6 phase  III  and 2 long‐term extension studies over 7 years.  MACE  (myocardial infarction, stroke, cardiovascular death) were independently adjudicated. Cox regression models were used to evaluate associations between baseline variables and time to first  MACE . Following 24 weeks of tofacitinib, changes in variables and time to future  MACE  were evaluated after adjusment for age, baseline values, and time‐varying tofacitinib dose. Hazard ratios and 95% confidence intervals were calculated.    Results  Fifty‐two  MACE  occurred in 4,076 patients over 12,873 patient‐years of exposure (incidence rate 0.4 patients with events per 100 patient‐years). In univariable analyses of baseline variables, traditional cardiovascular risk factors and glucocorticoid and statin use were associated with  MACE  risk; disease activity and inflammation measures were not. In subsequent multivariable analyses, baseline age, hypertension, and the total cholesterol to high‐density lipoprotein ( HDL ) cholesterol ratio remained significantly associated with risk of  MACE . After 24 weeks of treatment, an increase in  HDL  cholesterol and a decrease in the total to  HDL  cholesterol were associated with decreased  MACE  risk; changes in total cholesterol, low‐density lipoprotein ( LDL ) cholesterol, and disease activity measures were not. Increased erythrocyte sedimentation rates trended with increased future  MACE  risk.    Conclusion  In this post hoc analysis, after 24 weeks of tofacitinib treatment, increased  HDL  cholesterol, but not increased  LDL  cholesterol or total cholesterol, appeared to be associated with lower future  MACE  risk. Further data are needed to test the cardiovascular safety of tofacitinib.

arthritis and rheumatology

Risk Factors for Major Adverse Cardiovascular Events in Phase  III  and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis