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12/11/05 - 17/11/05, San Diego, USA
Highlights of the American College of Rheumatology 70th Annual
Scientific Meeting - Nov. 12-17, San Diego, USA.
San Diego, U.S.A.: 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
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
(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. ACR2 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.
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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.
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
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.
2The 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.