Safety of etanercept in elderly subjects with rheumatoid arthritis

Objective: To report side effects seen in a clinical cohort of patients aged <65 years with rheumatoid arthritis (RA) treated with the tumor necrosis factor-alpha TNF-alpha blocker etanercept and to compare the side effects rate with patients aged <65 years. Methods: All patients with RA that started etanercept and who were referred to our rheumatology unit from November 2005 to March 2009 were included in this study and prospectively followed to collect side effects related to therapy. Results: One hundred three patients were enrolled: 41 (37 females, 4 males) aged >65 years and 62 (40 females, 22 males) aged <65 years. In the patients aged >65 years, the safety profile (defined as rate of side effects) of etanercept was similar to that in patients aged <65 years (P > 0.05) and the survival curves between the groups were similar (P > 0.05). Conclusions: In our three-year experience, the anti-TNF alpha agent etanercept has been well tolerated and safe in elderly patients. The risk of side effects in these patients was no greater than in subjects aged <= 65 years. However, such inhibitors are associated with various and numerous side effects and elderly patients with RA should be carefully monitored to limit the risk of side effects during anti-TNF alpha therapy as much as possible.