Objectives: To investigate the efficacy, safety and survival of tumour necrosis factor (TNF) α antagonists in patients with rheumatoid arthritis (RA).
Methods: One hundred and fifty-one RA patients treated with TNF-α inhibitors during the time period 2000 to 2009 were studied. Kaplan-Meier statistic analysis was applied, in which discontinuation from anti-TNF-α therapy was used as the terminal event.
Results: Eighty-two patients received infliximab, 49 adalimumab and 20 etanercept: they were followed up over 7, 5 and 4 years, respectively. Anti-TNF-α therapy resulted in a rapid clinical improvement associated with a reduction in inflammatory markers in the first year of the treatment, which was sustained throughout the following years. Ninety (59.6%) patients were withdrawn during the observational period overall. The patients who discontinued infliximab, adalimumab and etanercept therapy were 55/82 (67.1%), 27/49 (55.1%) and 8/20 (40%) respectively. The main reasons for discontinuation were drug adverse events and inefficacy. According to Kaplan-Meier methods, the 'survival rate' of infliximab after the first year of treatment reached 82.9%, while after 7 years the proportion was 32.9%. With regard to adalimumab, after the first year of treatment its 'survival rate' was 83.7% and after 5 years it reached 44.9%. As far as etanercept is concerned, after the first year of treatment, the 'survival rate' reached 70% and after 4 years it remained 60%.
Conclusions: TNF-α antagonists constitute an effective therapeutic option for patients with RA refractory to disease-modifying anti-rheumatic drugs. They demonstrate an acceptable safety profile. Their survival rate is high in the first years of treatment, while after the fifth year it decreases considerably.