Date: 08 September 2017
Rheumatoid arthritis, an autoimmune disease that causes inflammation and damage in patients’ joints, currently affects around 600,000 people in the UK, with an estimated 20,000 new cases every year. Rheumatoid arthritis is a long-term condition that is estimated to cost the NHS over £560m a year, with societal costs of over £1.5b.
Biologic therapies have had a hugely beneficial impact in treating rheumatoid arthritis, however in real-world studies the response rate has been lower than expected. This coupled with the lack of sustained efficacy has driven the development of therapies aimed at previously unexplored targets. The second part of a Phase II randomised, multicenter clinical trial has opened to recruitment to test the monoclonal antibody RG6125 following the successful completion of the first part of the study that was conducted in the US. This study is a being supported by the NIHR Joint and related inflammatory diseases Translational Research Collaboration and F. Hoffmann-La Roche AG (Roche AG).
The second-line standard-of-care for rheumatoid arthritis is a combination of methotrexate and anti-TNF-alpha therapy; however, approximately 40% of patients do not have an adequate response to this treatment or become resistant within months.
The protein Cadherin-11, found on stromal cells in the joint, has been identified as a novel target for new RA therapies, in this case the monoclonal antibody RG6125 which is being investigated by Roche AG. RG6125 is believed to disrupt immune cell adhesion in a non-immunosuppressive manner and is now being tested in the second part of the Phase II trial for patients who are not responding to second-line standard-of-care treatment. The UK part of this clinical trial will be aiming to recruiting a minimum of 24 patients over the next 10 months who have moderate to severely active rheumatoid arthritis and are unresponsive to standard treatment.
The Roche RA study is being led by Dr Andrew Filer from the Institute of Inflammation and Ageing at the University of Birmingham. “This is the first example of a monoclonal antibody therapy that directly targets stromal cells in rheumatoid arthritis with the potential to control disease without adverse immunosuppressive effects” said Dr Filer, “If successful it will open the door to therapies targeting stromal cells in many more immune-mediated diseases”.
The NIHR Joint and related inflammatory diseases Translational Research Collaboration is where leading hospitals and universities work in partnership with the life sciences industry to carry out pioneering early phase research into potential new treatments. The clinical trial to evaluate RG6125 is taking place in 8 UK centres that are part of the Translational Research Collaboration.
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