Cardiac safety of TNF inhibitors in rheumatologic diseases: a one year-follow-up pilot study

Objective:TNF-aappears to play a role in Inflammatory Rheumatologic Diseases as well as in Heart Failure; some data in the literature alerted about the safety of TNF-ainhibitors in patients with concomitant overt heart failure, then leading even to a warning in NYHA class I and II patients. The aim of this study was to assess the cardiovascular safety of TNF-antagonism in patients with inflammatory rheumatic diseases based on a 1 year follow-up pilot study. Methods:20 consecutive patients (9 males) affected by inflammatory rheumatic diseases, starting treatment with TNF- aantagonists were studied at the enrolment (T0); ten were treated with Infliximab and ten with Etanercept. Exclusion criteria were: previous cardiovascular disease, heart failure, ischemic heart disease, dyslipidemia, hypertension, cigarette smoking, diabetes mellitus, family history of heart disease, other comorbidities (i.e. respiratory/renal diseases). Physical examination, blood pressure measurement, ECG and a complete echocardiographic assessment were obtained at T0 and at 3 (T3), 6 (T6) and 12 (T12) months. Disease activity was determined by DAS-28 index. All variables were compared with paired ‘‘Student’s’’ t test. Results:At baseline pts mean age was 45.8 (SD 8.15), years; mean disease duration was 14.4 (SD 8.876) years; mean DAS-28 score was 3.66 (SD 1.49); mean left ventricle diastolic diameter (LVDD) was 4.87 (SD 0.34) cm; mean interventricular septum thickness (ISVT) was 0.77 (SD 0.11) cm; mean left ventricle posterior wall thickness (LVPWT) was 0.79 (SD 0.11) cm; mean left atrium (LA) craniocaudal diameter was 4.7 (SD 0.29) cm; mean LV ejection fraction (EF) was 54.65 (SD 4.534) %; mitral E/A was 0.98 (SD 0.32); mean mitral deceleration time (M DT) 0.12 (SD 0.012) s; mean mitral isovolumetric relaxation time (M IRT) 0.14 (SD 0.018) s; mean systolic blood pressure (SBP) was 128.5 (SD 10.7) mmHg; mean diastolic blood pressure (DBP) was 81.65 (SD 6.9) mmHg; mean heart rate (HR) was 82.8 (SD 9.7) beat per minute (bpm). No statistically significant differences were observed for all parameters when comparing 3, 6 and 12 months values versus T0. There was a mildly positive, though non significant, trend in LVEF. Furthermore, during the follow up period no minor or major cardiovascular events were observed. Conclusion:Based on our preliminary data, Infliximab and Etanercept showed a satisfactory cardiovascular safety profile, according to both clinical and echocardiographic parameters. Further investigations could confirm these findings