New data reveal first predictive biomarkers to tailor rheumatoid arthritis therapy

New research presented at the British Society of Rheumatology (BSR) annual conference in Birmingham during April 2010 has confirmed what has been known anecdotally through clinical experience.

This data reveals that people with rheumatoid arthritis (RA) who test positive to certain auto-antibodies (these are markers that can indicate the presence of active disease) are more than twice as likely to achieve remission when taking MabThera (rituximab) plus methotrexate (MTX) than those who test negative.  Also, people who are seropositive are three times more likely to get a significant improvement in symptoms with rituximab than people who are seronegative. Approximately 80% of patients with RA are seropositive for one of these auto-antibodies, known as ‘rheumatoid factor’. Until now, no research into the treatment of RA has been able to identify biomarkers to pinpoint which patients would respond better to any specific treatment.

Professor John Isaacs, Professor of Clinical Rheumatology at Newcastle University and lead investigator commented: “This is an important breakthrough in the treatment of this chronic and debilitating condition, heralding the beginning of an exciting new era for patients, physicians and indeed the entire RA community.  Conventional practice is based on treating the patient population as a whole, leading to some patients cycling on ineffective treatments before achieving the optimum response. By identifying in advance which groups are most likely to respond to, or to have an enhanced response to, drugs like rituximab, we can ensure they are treated early enough to prevent irreversible joint damage and disability.  Additionally this will reduce treatment costs by avoiding the use of ineffective drugs”

Tailoring treatments to specific patient populations represents a major step forward in the approach to RA therapy, paving the way for more personalised treatment approaches.  
Ailsa Bosworth, Chief Executive, National Rheumatoid Arthritis Society (NRAS), commented: “What we have come to understand over time is that people are different and treatments that work well for one person will not work for another. The challenge with RA is finding the right therapy quickly, as the longer people linger on ineffective treatments, the more at risk they are of permanent joint damage and disability. Identifying those who are more likely to respond to a specific drug is a huge step forward and will hopefully lead to improved response and quality of life for many patients.”

Personalised healthcare or medicine involves the use of diagnostics and biomarkers to help identify those patients who are most likely to benefit from a drug.  The approach also helps identify those who are least likely to respond, which limits unnecessary treatment and side effects.  Traditionally, practitioners have made decisions on treatment based on patient history, observation, experience and intuition. Personalised medicine seeks to provide a further evidence-based factor to help practitioners decide on the best treatment for their patients.

John Melville, General Manager, Roche Products Limited, commented: “Personalised healthcare is an exciting concept that has the potential to improve the efficacy, safety and cost-effectiveness of treatments.  At Roche we are committed to investigating this approach in a number of disease areas, including RA.  We hope that with a better understanding of patient sub-groups, the right treatment can be matched to the right patient, delivering a much more effective healthcare approach in the future.”

About seropositivity
Serostatus is a term used to refer to the presence or absence of specific substances in the blood serum. Most commonly, this medical test is looking for specific antibodies in an effort to diagnose a particular disease.

About rituximab (MabThera®)
MabThera® (rituximab) is a product sold in the UK by Roche Products Limited. Rituximab is a monoclonal antibody, a type of man-made molecule that targets specific cells, or parts of cells, for destruction.  Rituximab binds to a particular protein, the CD20 antigen, which is expressed on the surface of normal and malignant mature B-cells, a type of white blood cell vital to the body’s immune system. Disruption to the normal function of B-cells is a hallmark of many diseases, including rheumatoid arthritis.