A new clinical research study has been launched that will explore why the current gold standard biological treatment for people with rheumatoid arthritis does not work in around a third of patients. The National Institute for Health Research (NIHR) study in partnership with Janssen will investigate key mechanisms associated with a lack of response to this treatment and its findings should open new routes for developing therapies for these patients.
Run by an NIHR Translational Research Partnership, the study will explore the molecular pathways that determine whether people with rheumatoid arthritis will benefit from treatment with anti-TNF (anti-tumour necrosis factor-alpha) therapies or not.
Anti-TNF therapies are the current gold standard treatment for people with rheumatoid arthritis who do not respond to more widely used anti-rheumatic drugs such as methotrexate. Unfortunately, anti-TNF therapies are not effective in around 30 percent of these patients. This causes a significant health burden. The reason for this lack of response has been unclear. However, the NIHR’s study should provide information that will enable better targeting of anti-TNF therapies and should lead to the development of new and alternative treatments for the up to half a million people in the UK affected by rheumatoid arthritis.
The study, which is led by Professor Costantino Pitzalis from Queen Mary University London is being run by the NIHR Joint and Related Inflammatory Diseases Translational Research Partnership (TRP). It is being funded by Janssen Research & Development and involves scientists from the organisation’s Immunology Therapeutic Area. Set to recruit 50 patients with rheumatoid arthritis from January 2015 over a period of 18 months, this collaborative study will run across seven research centres within the TRP. The NIHR Office for Clinical Research Infrastructure (NOCRI) worked closely with Janssen to provide a single point of access to the research expertise across the TRP.
Life Sciences Minister George Freeman said: “As we embrace the 21st century model of ‘Precision Medicines’, research into how and why existing drugs affect patients in different ways is vital to better targeting drugs and our NHS budgets to maximise benefits for patients.”
Mark Samuels from NOCRI said: “By seeking to understand the biological make-up of patients who respond to anti-TNF treatment, the success of this trial could bring hope to those suffering from the devastating impact of rheumatoid arthritis without treatment options. Providing the right patients with the right drugs at the right time will benefit both patients and the NHS.”
The stratification of patients in this study is not only expected to help define a better approach to experimental medicine in this therapeutic area, but also to support a new way for the pharmaceutical industry to approach early phase drug development. The study is underpinned by a single model agreement between Janssen and twelve of the universities and hospitals that are part of the TRP. This model Industry Collaborative Research Agreement (mICRA) is specifically designed to support multi-centre studies like this innovative rheumatology study. NOCRI has supported the establishment of this collaboration, continuing to engage companies, universities and NHS Trusts with new collaborative models.