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Roche Pharmaceuticals

Actemra Monotherapy Significantly Slows Down Damage to Joints in Patients With Early Aggressive Rheumatoid Arthritis

San Diego, California, November 17 (ots/PRNewswire)

- First Phase III Data Presented at the ACR Annual Meeting
Roche today announced the results of the first Phase III study in
rheumatoid arthritis (RA) conducted by Chugai in Japan which are
being presented at the American College of Rheumatology (ACR) Annual
Scientific Meeting in San Diego, USA. These data conclude for the
first time that Actemra in monotherapy shows superiority to
conventional disease modifying anti-rheumatic drugs (DMARDs) in
inhibiting radiographic progression of joint destruction. The data
also show Actemra dramatically improves the painful and disabling
symptoms of patients with rheumatoid arthritis.
Actemra (tocilizumab) is a humanized anti-human interleukin-6
(IL-6) receptor monoclonal antibody that offers a novel mechanism of
action and may become a new therapeutic option for the treatment of
RA.
Rheumatoid arthritis is a debilitating autoimmune disease in which
the lining of the joints becomes inflamed causing irreversible joint
damage and destruction. Patients experience pain, stiffness, swelling
and ultimately loss of mobility.
"These data show the progression of patients' joint damage is
substantially reduced over the one year period. Furthermore, the
important role of IL-6 blockade is highlighted by the clinical
benefits experienced in this Actemra monotherapy study. Following
these impressive results, we look forward to the outcome of the large
phase III programmes currently being run in Europe and the US with
Actemra in combination with other anti-rheumatic drugs," commented
Dr. Eduard Holdener, Head of Global Pharma Development, Roche.
Impressive results achieved with Actemra in patients with early,
aggressive disease
Of the 302 patients evaluated in this monotherapy study, patients
in the Actemra arm showed significantly less radiographic joint
destruction compared to patients in the DMARDs control group as
measured by change in total Sharp score (1) (2.3 +/- 5.6 vs 6.1 +/-
11.4; p=0.001). Furthermore, Actemra was superior to DMARDs in
preventing both erosion and joint space narrowing. Disease Activity
Scores (DAS) were 6.9 and 6.8 at baseline, Actemra and DMARDs control
groups respectively, indicating very active disease. Following one
year of treatment, DAS in the Actemra arm fell to 2.5 and to 5.7 in
the DMARDs control group. ACR(2) response rates in the Actemra arm
were significantly higher than those in the DMARDs control arm:
percentages of Actemra patients achieving ACR20, 50 and 70 were 89%,
70% and 47% respectively compared to 35%, 14% and 6% respectively in
the DMARDs group. Results of this magnitude have not been previously
achieved in rheumatoid arthritis patients who have early aggressive
disease.
Actemra generally well tolerated
The overall incidence of adverse events including laboratory
abnormalities was 96% and 87% in the Actemra and DMARDs control arms
respectively. While lipid increases were reported in the Actemra
group, the mean cholesterol level stabilized around the upper limit
of normal. No tuberculosis was observed and Actemra monotherapy was
generally well tolerated.
Editor's Notes
About the study
This phase III clinical trial is a randomized trial in which 306
patients with active early rheumatoid arthritis of < 5 years'
duration were allocated to receive either Actemra as a monotherapy at
8 mg/kg I.V. every 4 weeks or conventional DMARDs for 52 weeks. In
the control group, the dose, type and combination of DMARDs could be
varied according to disease activity, but anti-TNF agents and
leflunomide were not permitted. The efficacy endpoints included
change from baseline to week 52 in van der Heijde modified Sharp
score, evaluated in blinded manner, and ACR response rates.
About Actemra
Actemra is a first-in-class humanized anti-IL-6 receptor
monoclonal antibody whose novel mechanism of action may provide a new
and effective form of treatment for adult RA. Phase II studies have
been completed in Japan and Europe. Collaborative phase III clinical
development in RA has been completed by Chugai in Japan and is
underway outside Japan with more than 4000 patients expected to be
enrolled in over 20 countries including several European countries
and the USA.
Roche and Chugai are developing Actemra in collaboration with
Osaka University. This co-development partnership was set up under
the first licensing agreement between the two companies in 2003,
where Roche was granted the right to promote in all countries except
Japan, South Korea and Taiwan, and the parties would co-promote in
the UK, France and Germany.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in joints. This
inflammation causes a loss of joint shape and function, resulting in
pain, stiffness and swelling, ultimately leading to irreversible
joint destruction and disability. Characteristics of RA include
redness, swelling, pain, and movement limitation around joints of the
hands, feet, elbows, knees and neck. In more severe cases of RA the
eyes, lungs or blood vessels may be involved. RA may also shorten
life expectancy by affecting major organ systems and after 10 years,
less than 50% of patients can continue to work or function normally
on a day to day basis. RA is one of the most common forms of
autoimmune disease and affects more than 21 million people worldwide.
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 2004
sales by the Pharmaceuticals Division totalled 21.7 billion Swiss
francs, while the Diagnostics Division posted sales of 7.8 billion
Swiss francs. Roche employs roughly 65,000 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.
References:
[1] Total Sharp Score (TSS) is a method by which to evaluate joint
destruction of RA patients, which is calculated based on erosion
score and joint space narrowing from bone x-rays.
[2] 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 or 50% level of reduction (the
percentage of reduction of RA symptoms) is represented as ACR20,
ACR50 or ACR70. An ACR70 response is exceptional for existing
treatments and represents a significant improvement in a patient's
condition.

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site), International Communications Manager, Tel: +41-79-619-1765.
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