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Friday 21 July 2006

Thousands to Benefit from Launch of Novel Rheumatoid Arthritis Therapy

By: Caroline Tatum, Rachel Bannister

Current Treatments Failing Nearly 30% of Patients with Severe RA : MabMabThera®(rituximab) Offers New Hope

MabThera®, the first B-cell therapy to treat severe active rheumatoid arthritis (RA), which is now available in the UK, is set to transform the management of this debilitating disease and may make a difference to the lives of thousands of people. MabThera, in combination with methotrexate, a standard RA medicine, has been licensed for the treatment of adults with severe active RA who have failed on the current gold standard anti-TNF therapies.

Adults with severe active RA, many of whom are only in their 30s and 40s, can suffer relentless pain, extreme fatigue and disability. Currently nearly 30% of people who receive the existing anti-TNF treatments for severe active RA do not respond to or cannot tolerate these therapies.1 Until now there have been no effective alternative treatment options for them. MabThera works by directly targeting cells in the immune system, called B-cells, which are known to play a key role in the development and progression of RA. This new therapy, with its innovative mode of action, offers a new approach to the treatment of severe active adult RA and potentially heralds a new era in its management.

Ailsa Bosworth, Chief Executive and founder of the National Rheumatoid Arthritis Society (NRAS), believes the launch of MabThera is very welcome news for people with RA: “This is a cruel disease that often strikes people in their prime and can have a dramatic effect on their quality of life. Sadly, a significant minority of patients do not respond well to existing therapies for severe RA, particularly if they have had the disease for a number of years and have significant joint damage. The availability of MabThera will be extremely important in addressing the unmet needs of these patients.”

Delaying and improving the symptoms of RA will not only benefit patients – it may have a significant beneficial impact on the cost of RA to the wider community. Between 1999-2000, 9.4 million working days were lost in Great Britain due to this disease, the equivalent of £833 million in lost production. The total direct and indirect costs of RA in England alone have been estimated at as much as £1.2 billion per year. In the long-term, MabThera may impact on these costs.

Professor Paul Emery, arc Professor of Rheumatology, Leeds Teaching Hospitals NHS Trust comments, “This is a very exciting time – with the launch of MabThera we have a new approach that has the ability to provide long lasting clinical benefits for patients who do not receive relief from existing treatments.”

MabThera, in combination with methotrexate, is licensed for the treatment of severe active RA in adult patients who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including one or more anti TNF therapies.2 The short course of therapy, two infusions is two weeks apart, with between six to twelve months before further treatment.2 Research has shown that regular infusions place a burden on people with RA.

The disease affects around 387,000 people in the UK alone, and occurs when a person’s immune system attacks their own joints, often causing severe damage to the joints resulting in pain and disability. One in 100 people in the UK will develop RA over their lifetime.6 The disease can affect other organs and people with RA are at greater risk of heart disease and stroke and have a reduced life expectancy.

MabThera, in combination with methotrexate, has shown to be highly effective in controlling the signs and symptoms of severe active RA, its safetly profile has been investigated in the RA population. The majority of side effects were mild to moderate and related to the infusion of the drug but as with all therapies in RA a small proportion of more serious side effects were seen. MabThera already has a well-established safety profile having been prescribed to over 730,000 patients worldwide with non-Hodgkin’s lymphoma (NHL).

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