Clinical Remission Figures Double For People With Rheumatoid Arthritis Following Multiple Courses Of MabThera (rituximab)

Results of the REFLEX study1 show that the number of people with rheumatoid arthritis
(RA) achieving clinical remission from their disease doubled over three successive
treatment courses with MabThera (rituximab) when used in combination with
methotrexate (from 8.8% achieving clinical remission* after the first course to 17.6% after
the third course). These data confirm that MabThera may continue to improve RA
symptoms with each subsequent course of treatment, maximising patient response in
those with severe RA who have failed to respond adequately to tumour necrosis factor
(TNF) inhibitors, the most commonly prescribed first-line biologic therapy for RA.


The study also revealed almost twice as many people with RA achieved a 70%
improvement in their symptoms after their third course of treatment compared to their
first course of treatment (increase in ACR70* response from 14% to 25.7%). The results
of the long term follow up to the pivotal REFLEX study, involving 2578 patients, are being
presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in
San Francisco.


"These results clearly demonstrate that prolonged treatment with MabThera leads to an
improvement in symptoms for people with rheumatoid arthritis who do not respond
adequately to TNF inhibitor therapy," said Professor Paul Emery, arc Professor of
Rheumatology, University of Leeds, Leeds Teaching Hospitals Trust. "The striking
improvement in remission signifies the important place it holds in the long-term
treatment of RA".


Long-term treatment also shown to reduce joint damage


Additional data demonstrate that long-term treatment with MabThera continues to
significantly inhibit the progression of joint damage (compared with placebo) over a
period of two years in those people with RA who do not respond to TNF inhibitor
therapy.2 This was measured using X rays. Joint damage can lead to severe disability and
pain in people with RA, therefore the inhibition of structural damage is a major goal of
treatment. In people with RA who do not respond to TNF inhibitor therapy, MabThera is
the first and only therapy to have demonstrated a reduction in joint structural damage.


Data demonstrate long-term safety


Six-year follow-up data also presented at the ACR annual meeting prove that MabThera
continues to demonstrate a consistent safety profile over several courses of treatment. The
safety profile remained constant with the number of infections, including serious
infection events, being low (4.31/100 pt-years (95% CI: 3.77-4.92)). These results add to
the wealth of data contributing to MabThera's safety profile in RA with 5013 patient-years
of follow-up now collected.3


About rheumatoid arthritis (RA)


RA affects around 487,000 people in the UK4,5 and is a painful, debilitating and incurable autoimmune
disease in which the body attacks itself. It is an incredibly painful condition, can cause
severe disability (this varies between individuals and depends on how severe/aggressive the disease
is) and ultimately affects a person's ability to carry out everyday tasks. Any joint may be affected
but it is commonly the hands, feet and wrists. It is a systemic disease which means that it can
affect the whole body and internal organs such as the lungs, heart and eyes. Current available
treatments for the disease include disease-modifying anti rheumatic drugs (DMARDs) and
biologic therapies.















About MabThera


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 and the drug breaks the inflammatory cascade of RA - a
series of reactions inflaming the synovia and leading to the cartilage loss and bone erosion that is
characteristic of the disease, and may provide an innovative new treatment even in patients with
severe and long-standing disease. MabThera has a strong heritage in the treatment of a form of
lymphatic cancer called non-Hodgkin's lymphoma (NHL) and the treatments safety profile has
now been established in more than a million patient exposures over the last nine years in oncology
and more recently rheumatoid arthritis.


MabThera is indicated, in combination with methotrexate, for the treatment of adults with severe
rheumatoid arthritis who cannot tolerate or do not respond to anti-TNF therapy.


About Roche in rheumatoid arthritis


One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first
indication. Additional projects creating a rich pipeline include compounds in Phase I, II and III
clinical trials.



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, and a major supplier of medicines for the
treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal
anaemia. Find out more at rocheuk.
A summary of product characteristics is available at rocheuk.


References


1. Keystone, EC et al. Efficacy and safety of repeat treatment courses of rituximab (RTX) in RA patients with
inadequate response to tumor necrosis factor inhibitors: long-term experience from the REFLEX study.
ACR 2008.


2. Cohen S et al. Continued inhibition of structural damage in RA patients treated with rituximab at two
years: REFLEX study. ACR, 2008.


3. van Vollenhoven, RF et al. Long-term safety of rituximab: 6-year follow-up of the RA clinical trials and retreatment
population. ACR 2008.


4. National Statistics Online, UK Population Estimates. statistics.uk/CCI/nugget.asp?ID=6
(Last accessed October 2008)


5. Symmons D et al. Rheumatology 2002;41:793-800


* The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic
therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined
percentage reduction in a number of symptoms and measures of their disease. For example, a 20%, 50% or
70% level of reduction is represented as ACR20, ACR50 or ACR70. An ACR 70 response is exceptional for
existing treatments and represents a significant improvement in a patient's condition.

Roche UK