San Diego, U.S.A.: Roche today announced positive results of the Phase III REFLEX study, evaluating the efficacy and safety of MabThera in patients with rheumatoid arthritis (RA), who have had an inadequate response to anti-TNF biologic therapy. The data were presented today at the American College of Rheumatology meeting in San Diego, California and demonstrate that MabThera (rituximab) significantly improved all efficacy measures of rheumatoid arthritis (RA) for six months following a single course of just two administrations. MabThera provided relief to almost three times as many patients compared to placebo. Currently these difficult-to-treat patients, who represent at least 30% of all those treated with existing biologic therapy, are left with few treatment alternatives.

These data herald the start of a unique way to treat RA, a common condition affecting over 21 million people worldwide, in which the immune system attacks the joints, often causing severe swelling, pain, fatigue and disability. Traditionally, biologic therapy is focussed on blocking the action of an immune system molecule called TNF while MabThera is the first and only RA treatment to target specific types of immune cells, called B cells. B cells play a key role in the chain of inflammatory events that ultimately lead to the damage of bone and cartilage in the joints, characteristic of RA. Moreover, MabThera's long-term treatment success was achieved following just 2 administrations, 2 weeks apart, providing a highly convenient regimen. Presenting the results, Dr Stanley Cohen, M.D. Lead REFLEX investigator and Clinical Professor, Department of Internal Medicine at the University of Texas Southwestern Medical School, Dallas, commented, "These data will be of great interest to both physicians and patients, since they suggest that MabThera may offer patients the opportunity of at least six months relief of their symptoms with just two infusions. We observed MabThera responses as bein
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Contact: Rebecca Hibble
rebecca_hibble@uk.cohnwolfe.com
44-20-7331-5336
Cohn & Wolfe, London
16-Nov-2005

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