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Despite being effective, the biologics approved for treating rheumatoid arthritis have been associated with serious adverse events. This study is aimed at comparing the safety profiles of adalimumab, etanercept and infliximab by analysing the disproportionalities of the associations between the different adverse events and the different biologics in the Portuguese spontaneous reporting database.

Adverse events spontaneously reported to the Portuguese pharmacovigilance system (PPS) between 2009 and 2011 were included. Adverse events were classified according to MedDRA^® in the primary system organ class. The reporting odds ratio (ROR) and its 95% confidence intervals (CI) were calculated for each biologic regarding the various categories of adverse events. Microsoft Excel^® was used to perform all the calculations.

The PPS received …