ABSTRACT
Anti-tumour necrosis factor (TNF)-alpha represents a major advance in the treatment of rheumatoid arthritis (RA), ankylosing spondylitis and psoriatic arthritis. It is usually well tolerated, but a potential increase in the incidence of some infections in patients taking anti-TNFalpha agents has been reported. Compared with younger people, elderly patients have more co-morbidities and are likely to be taking more medications. Moreover, the aging process induces an increase in the rate of infections. Nevertheless, in recent studies analysing the databases of etanercept trials, the normalised incidence of adverse events, serious adverse events, medically important infections and deaths was not increased in patients aged >or=65 years. However, these trials included patients who might have been healthier than elderly RA patients in the general population and therefore not truly representative. Conflicting results have been reported in several 'real-life' observational studies. Taken together, the available data are reassuring for carefully selected populations, at least for etanercept, but it is not possible to claim that anti-TNFalpha agents do, or do not, pose a particular risk for the general population of older patients. Additional studies aiming at determining the safety and benefit-risk ratio of anti-TNFalpha agents in elderly patients are needed. In addition, since the benefit-risk ratio of anti-TNFalpha agents might be different in patients aged 65, 75 or >80 years, when possible, subgroup analysis might also be useful.