Biologics registers in rheumatoid arthritis

Abstract

The introduction of biologic therapies has resulted in improved outcomes in patients with rheumatoid arthritis (RA), although there are concerns about the long-term safety of these drugs, specifically relating to lymphoma and serious infection. Biologics registers have been established worldwide to investigate the long-term safety and effectiveness of biologic drugs in inflammatory conditions such as RA.To date, publications from biologics registers have focused mainly on anti-tumour necrosis factor (TNF) therapy, although reports of outcomes after other biologic classes, such as anti-interleukin-6 and anti-CD20 therapies, are increasing. The reports show that, in general, biologic therapies are effective in treatment of RA. However, registry data have shown that anti-TNF agents and rituximab are also associated with higher rates of serious infection. Lymphoma risk does not appear to increase in patients on anti-TNF therapy up to 5 years compared with patients given conventional synthetic disease-modifying anti-rheumatic drugs, but limited follow-up and numbers of patients taking other classes of biologic agents mean that lymphoma risk calculations are not yet available for those classes.Moving forward, biologics registers will continue to capture long-term follow-up of biologic therapies in RA, as well as to incorporate new classes of biologics and other advanced therapies, such as the new kinase inhibitors. Furthermore, the introduction of biosimilars will require further evaluation of safety and effectiveness. This will extend our knowledge of the long-term safety and effectiveness of biologic drugs when used in ‘real-life’ situations and across conditions.