European biologics registers

Abstract

Over the last 15 years, the European biologics registers have greatly increased our knowledge of the safety and effectiveness of biologic therapies in daily practice. They have convincingly shown that tumour necrosis factor (TNF) inhibitors do not increase the overall risk of solid or lymphoproliferative tumours. However, a slight increase in the risk of skin cancer cannot be ruled out. A higher risk of serious infections compared to csDMARDs has been identified which has to be taken into account in clinical care. The registers have identified the great impact of uncontrolled high disease activity on the risks of myocardial infarction, stroke, and overall mortality which underlines the importance of tight disease control. By their clinical effectiveness, the biologic agents therefore have the potential to prevent adverse outcomes. Overall, a favourable benefit-risk profile of TNFi and other biological agents has been observed, with some specific precautions in defined patient groups.