Date published: 01.09.08 - not release date

Thousands to Benefit from Launch of Novel Rheumatoid Arthritis Therapy

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

MabThera®, the 1st 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 1000's 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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For further info or interview requests, contact:

Red Door Communications
Caroline Tatum / Rachel Bannister
Telephone: 020 8392 8040
Email: ctatum@rdcomms.com / rbannister@rdcomms.com

Roche
Teva Dawson
Telephone: 01707 366861
Email: teva.dawson@roche.com

Editor’s Notes:

About Rheumatoid Arthritis and MabThera®
Rheumatoid arthritis is an autoimmune disease characterised by inflammation that leads to painful, stiff and swollen joints. Current treatments include disease-modifying drugs (DMARDS) and biologic therapy such as the anti-TNF drugs.

MabThera® is a first-in-class therapy that selectively targets B-cells early in the inflammatory cascade of rheumatoid arthritis. B-cells are known to play a key role in the inflammation associated with rheumatoid arthritis.

REFLEX (Randomised Evaluation oF Long-term Efficacy of RituXimab in RA) is a pivotal Phase III study evaluating the efficacy and safety of rituximab in combination with methotrexate (MTX) in patients with the most difficult-to-treat RA – those with long-standing, severe disease who have failed to respond or are intolerant to anti-TNF therapy.9

Over a six month period, more than 50% of patients showed a 20% improvement in signs and symptoms of RA, compared to less than a fifth of patients treated with MTX and placebo. 9

About Roche in the UK:

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world’s leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology.

Find out more at www.rocheuk.com.

References:

Hyrich KL, Silman Aj, Lunt M et al. Influence of Response and Adverse Events Rates to a First Anti-TNF Agent on the Outcome from Switching to a Second Agent: Results from the British Society of Rheumatology Biologics Register. Arthritis and Rheumatism 2005; 52(9): 857 (S339)

MabThera RA Summary of Product Characteristics, July 2006
Department of Works and Pensions. Analytical Services Division www.dwp.gov.uk

In Arthritis Research Campaign (ARC) Arthritis: the big picture 2002 [Online] http://www.arc.org.uk/about_arth/BigPic.pdf [Accessed
16/06/2006]

McIntosh E. The cost of rheumatoid arthritis. Brit J Rheumatol 1996; 35: 781-790.

Rheumatoid Arthritis – anti TNF treatments. Market research conducted by Hall and Partners, January 2006
Symmons DPM , Turner G, Webb R et al. The prevalence of rheumatoid arthritis in the United Kingdom - new estimates for a new century. Rheumatology 2002; 41:793–800.

Arthritis Research Campaign. Rheumatoid Arthritis: An Information Booklet. http://www.arc.org.uk/about_arth/booklets/6033/6033.htm#body

Textbook of Medicine. Third Edition, Edited Souhami and Moxham, Churchill Livingstone, Second Reprint, 1998, page 922.

Cohen SB, et al. Efficacy and Safety of Rituximab in Active RA Patients who Experienced an Inadequate Response to One or More Anti-TNFα Therapies (REFLEX Study). Presented at the American College of Rheumatology congress, 12th – 17th November, 2005.
Data on File. Rituximab PSUR 1018466