Ten Year Risk of Cardiovascular Events during anti-TNF Alpha in Rheumatoid Arthritis Patients

Abstract Objective: To analyze the rate of major CV events in 433 patients with longstanding RA, treated for more than 10 years with anti-TNFα or DMARDs. Methods: All RA patients treated with anti-TNF-α from 2000 and 2002 (n. 86; TNF+ group) and a random sample of 258 patients treated with DMARDs out of 829 followed-up in the same period in the same Unit (TNF- group) were analyzed. Myocardial infarction, heart failure, stroke, transient cerebral ischemic attack were considered. Exposure (anti-TNF-α vs. DMARDs) and outcome (CV events) were analyzed by the proportional hazard Cox regression, adjusting for RA duration, DAS 28, seropositivity (RF, anti CCP), treatment and Framingham CV risk factors (adjusted according to EULAR recommendations). Results: CV events were detected in 18.9% of cases with an incidence rate of 2.4% patients/year (95%CI: 1.5-3.7) in TNF+ and 1.3% patients/year (95%CI: 0.9-1.7) in TNF- group. Events occurred after a mean of 8.3 ± 3.6 years of anti-TNF exposure and 13.3 ± 8 years of DMARDs exposure (p: 0.006). Cox analysis, adjusted for sex, age, CV risk factors, DAS28, FR positivity, corticosteroids, anti-inflammatory drugs and methotrexate treatment, showed that only Framingham risk score is slightly associated with CV events (HR: 1.03, 95%CI:1.01-1.06). In addition, diabetes (p: 0.017) and coronary artery disease (p: 0.015) were associated with myocardial infarction, while higher age at RA onset (p: 0.02) and Framingham risk score (p: 0.0008) were associated with heart failure. Conclusions: CV events occurred in 2.4% patient/year during anti-TNF alpha treatment. A strict cardiovascular monitoring was mandatory in order to prevent major CV events.