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Anti-tumour necrosis factor therapy has proven effective as treatment against a series of autoimmune inflammatory diseases, and has displayed a rapidly increasing market penetration. The safety profile of these drugs is, however, both uncertain and debated, in particular with respect to infections and malignancy. Lack of uniform definitions and methods of analysis makes it difficult to directly compare data from randomized controlled trials, meta-analyses of trials, open-label extensions, data from spontaneous reporting, and particularly, observational cohort studies.In this review, we provide a summary of currently published data on infection, malignancy, cardiovascular disease, interstitial lung disease, and death in relation to treatment of rheumatoid arthritis with anti-tumour necrosis factor agents.Superficially contradictory data on infection display a more or less coherent pattern of an increased risk shortly after treatment starts. Available data on malignancy, cardiovascular disease, interstitial lung disease, and death do not exclude clinically important increased risks, nor do they refute beneficial effects. Harmonized methods of reporting safety data would greatly improve the interpretation and comparison of class and drug-specific risks.