Studying the Safety of Biotech Products Using Registries
Traditionally, medicines are based on small molecules, but over the last decade an increasing proportion of new drugs in development are so-called “biotech” or “biological” products. Such products are based on molecules or cells that are naturally found in the body, and include, among others, monoclonal antibodies, vaccines (including DNA vaccines), growth factors and cytokines. The majority of biotech products are monoclonal antibodies and most are used to treat cancer or rheumatic disease. Examples include Rituximab for non-Hodgkin’s lymphoma, and Etanercept for rheumatoid arthritis.
At the DSRU we would like to expand our research capabilities to study the safety of these products. Biotech products are generally not prescribed by GPs, but are administered in a hospital or clinic by specialists. These products tend to be much more costly than traditional medicines, and they are consequently only given to the proportion of patients with a certain type or severity of disease. Thus patient numbers are often low. These features will present particular challenges for the DSRU in monitoring the safety of biotech products.
One approach to facilitate data gathering on the use of biotech products is to establish a registry. The British Society for Rhuematology Biologics Register (http://www.medicine.manchester.ac.uk/arc/BSRBR/) is well-established and aims to monitor the long-term safety profile of anti-TNFα therapy. The register includes data on over 15,000 patients receiving biologic treatment (etanercept, infliximab, adalimumab and anakinra) for rheumatoid arthritis, ankylosing spondilitis, psoriatic arthritis and other rheumatological conditions.