New Evidence Shows MabThera Inhibits Joint Damage in Patients With Rheumatoid Arthritis

Basel, Switzerland and Amsterdam (ots/PRNewswire) -

- First RA Drug to Achieve These Results in Patients With an
Inadequate Response to Currently Available Treatments

New data presented at the EULAR meeting (European League Against
Rheumatism) show for the first time that MabThera (rituximab), a
unique B cell targeted therapy, is able to significantly inhibit
structural damage of joints caused by rheumatoid arthritis (RA). The
study was conducted in patients who had an inadequate response to one
or more TNF inhibitors and they received either MabThera plus
methotrexate (MTX) or MTX alone. X-ray evidence at 56 weeks showed
that the progression of bone erosions and progression of narrowing of
joint spaces in patients in the MabThera group were reduced by more
than 50 % compared to patients receiving MTX alone (erosion scores of
0.59 and 1.32 respectively; joint space narrowing scores of 0.41 and
0.99 respectively).

Damage to the structure of the joints ultimately causes
destruction of the joints and contributes to joint deformity and loss
of mobility. Patients' ability to work and perform every day tasks
such as getting dressed, walking and eating can be severely hampered.

Presenting the results, Professor Keystone, Rheumatology
Department at the University of Toronto, Canada, said: "This is the
first evidence demonstrating that MabThera can inhibit structural
joint damage in patients with an inadequate response to one or more
TNF inhibitors. Preventing structural damage is a critical outcome in
treating rheumatoid arthritis. These X-ray data confirm MabThera as
an effective and innovative therapy for patients with rheumatoid
arthritis and highlight the value of targeting B cells."

Repeat treatment courses

Additional new data presented at EULAR demonstrate that repeat
courses of MabThera in RA patients, 6 to 12 months after the initial
course, provide continued improvement of symptoms across all clinical
measures. Each treatment course consists of two infusions of 1000mg
given two weeks apart. The challenging goal of treatment in RA is
remission and, following a second course of MabThera in patients with
an inadequate response to one or more TNF inhibitors, the number of
patients achieving remission doubled from 6 % following an initial
course to 13 % following a second course. A similar trend was seen
for those achieving the hard-to-reach goal of a 70 % improvement in
symptoms (ACR70), with responses increasing from 12 % following an
initial course to 21 % following a second course.

Patient perspectives

Importantly, data presented at EULAR show improvements in clinical
scores are reflected in patient reported outcomes.

"While it is important to a physician to address a disease from a
clinical perspective, what matters most to the patient is whether
they are able to function normally and how well they feel. For
example, the impact of fatigue is often underestimated, but this is
something which really impacts patients' lives. MabThera has
demonstrated continuous improvements in physical and mental health
aspects with repeated courses of therapy", said Professor Tak,
Director, Division of Clinical Immunology and Rheumatology at the
Academic Medical Centre/University of Amsterdam, The Netherlands.

Editors notes:

Approval Status

On 2 June 2006 MabThera received a recommendation for approval
from the Committee for Medicinal Products for Human Use (CHMP) for
the treatment of rheumatoid arthritis (RA) in Europe. MabThera, in
combination with methotrexate, has been recommended for the treatment
of adult patients with severe active rheumatoid arthritis who have
had an inadequate response or intolerance to other disease-modifying
anti-rheumatic drugs (DMARDs). On 28 February 2006, after priority
review, Genentech and Biogen Idec received US approval for Rituxan(R)
(rituximab in the US) for the treatment of adult patients with
moderately to severely active RA in combination with methotrexate for
reducing signs and symptoms in those RA patients who have had an
inadequate response to one or more tumour necrosis factor (TNF)
antagonist therapies.

About the REFLEX study

The REFLEX study (Randomised Evaluation oF Long-term Efficacy of
MabThera in RA) is a multi-centre, randomized, double-blind,
placebo-controlled Phase III study. In this trial, patients who
received a single course of only two infusions of MabThera with a
stable dose of methotrexate (MTX) displayed a statistically
significant improvement in symptoms measured at 24 weeks, compared to
those receiving placebo and MTX. Patients receiving additional
courses did so between 6 and 12 months after the initial course.
Consistent with previous findings, analysis of the REFLEX 56-week
data did not reveal any unexpected safety signals. The companies
continue to monitor the long-term safety of rituximab in all clinical
trials.

A further phase III development programme for MabThera therapy in
patients with rheumatoid arthritis who have had an inadequate
response to disease modifying anti-rheumatic drugs (DMARDs) is
ongoing.

Long term safety and repeated courses

Further new data of a pooled analysis presented at EULAR confirmed
the safety profile of rituximab identified in the original randomised
clinical trials. The analysis included all RA patients treated with
MabThera during clinical development which amounted to over 1,600
patient years with some patients being followed for over 3 years,
many of whom had received multiple courses of treatment. This
analysis did not reveal any unexpected safety signals.

About MabThera in rheumatoid arthritis

MabThera selectively targets a subset of B cells that express
CD20, leaving stem, pro-B and plasma cells unaffected. This subset of
B cells plays a key role in the autoimmune process of RA and MabThera
aims to interrupt this process by inhibiting a series of reactions
inflaming the synovia and leading to cartilage loss and bone erosion
that is characteristic of the disease. More than 1,000 patients with
RA have been treated with MabThera in clinical trials to date. A
comprehensive Phase III clinical development programme is also
currently underway to further investigate the potential clinical
benefit of MabThera in earlier RA.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines for
cancer and transplantation and a market leader in virology. In 2005,
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on
the Internet (www.roche.com).

All trademarks used or mentioned in this release are legally
protected.

For further information:

- About EULAR: www.eular.org

- British Society for Rheumatology: www.rheumatology.org.uk

- American College of Rheumatology: www.rheumatology.org

- About Genentech: www.gene.com

- About BiogenIdec: www.biogenidec.com.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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