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Actemra: Roche's Novel Rheumatoid Arthritis Drug Shows Substantial Benefits for Patients in OPTION Study

Basel, Switzerland (ots/PRNewswire)

- New Data Supports IL-6 Receptor Inhibition as a Key Component in
Controlling Inflammation From RA
Roche today announced significant results from 'OPTION'(1), the
first rheumatoid arthritis multinational phase III study of Actemra
(tocilizumab) outside of Japan. The data presented at the EULAR(2)
meeting in Barcelona, Spain, showed that patients who received
Actemra in combination with methotrexate achieved rapid and
significant improvement in their signs and symptoms of rheumatoid
arthritis when compared to patients receiving methotrexate alone.
In the 24-week study, four times the number of patients in the
Actemra group experienced 50% improvement in disease symptoms
(ACR50(3) response) compared to the control group (44% vs 11%). More
than ten times the number of Actemra patients achieved 70%
improvement in disease signs and symptoms (ACR70 response) compared
to the control group (22.0% vs 2.0%). In addition, 28% of patients
achieved the ultimate goal of remission4 in the Actemra group vs only
1% of patients in the control group.
"The efficacy of IL-6 receptor inhibition in this study confirms
the critical role of IL-6 in the causal pathways of rheumatoid
arthritis. On this basis, the profound clinical success observed with
tocilizumab by targeting a novel pathway is extremely encouraging as
is the opportunity for rheumatoid arthritis patients to benefit from
a potential new treatment option," commented lead investigator,
Professor Josef Smolen.
"The detailed data from the OPTION study, together with the first
data from the TOWARD study announced last week, show a great benefit
for rheumatoid arthritis patients. We look forward to further results
from our extensive multinational Phase III development programme
later this year" commented William Burns, CEO Division Roche
Pharmaceuticals.
Other parameters measured included C-reactive protein (CRP), a
marker of inflammation, fatigue and haemoglobin. Patients in the
8mg/kg Actemra group showed a rapid normalisation of the CRP levels
within 2 weeks while fatigue scores showed that patients in the
Actemra group experienced a reduction in fatigue and a rapid
improvement in haemoglobin levels. Low levels of haemoglobin are
usually associated with anaemia which makes patients feel tired and
lacking in energy.
About the OPTION study
The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate
respONders) study was an international study involving 623 patients
with moderate to severe RA. In this 3-arm, randomized, double-blind
study, patients received tocilizumab intravenously (either 4mg/kg or
8mg/kg) every 4 weeks plus methotrexate weekly or placebo infusions
plus methotrexate weekly over a period of 6 months.
Although higher efficacy was established at the higher dose
(ACR20, 50 and 70 scores of 59%, 44% and 22% respectively in the
8mg/kg Actemra group), patients treated with the lower dose of
Actemra (4mg/kg) achieved ACR20, 50 and 70 scores of 48%, 32% and 12%
respectively. Furthermore there was a reduction in the Disease
Activity Score (DAS) from week 2 onwards for both the 8mg/kg (-3.43)
and 4mg/kg (-2.68) Actemra groups compared to control (-1.55).
Remission of disease was demonstrated in 28% of patients treated with
8mg/kg of Actemra and methotrexate vs 14% of patients treated with
4mg/kg of Actemra and methotrexate vs 1% or patients receiving
methotrexate alone.
Actemra was generally well tolerated with an adverse event (AE)
profile consistent with data reported in previous studies(5).
ENDS
Notes to Editors
About Actemra
Actemra is the first humanised interleukin-6 (IL-6) receptor
inhibiting monoclonal antibody and represents a novel mechanism of
action to treat RA, a disease with a high unmet medical need. Roche
and Chugai are collaborating on a phase III clinical development
programme in RA running outside Japan, with more than 4000 patients
enrolled in 41 countries including several European countries and the
USA. In Japan, Actemra was launched in June 2005 as a therapy for
Castleman's disease and in April 2006 filed for the additional
indications of rheumatoid arthritis and systemic-onset juvenile
idiopathic arthritis.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by chronic inflammation of multiple joints and fatigue
as well as the possibility of osteoporosis, anaemia, and lung, skin
and liver effects. This inflammation causes pain, stiffness and
swelling, resulting in loss of joint function due to destruction of
the bone and cartilage, often leading to progressive disability.
Further, as chronic inflammation continues, there may be shortening
of life expectancy as a result of effects on major organ systems.
After 10 years, less than 50% of patients can continue to work or
function normally on a day to day basis. RA affects more than 21
million people worldwide.
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. Following the launch of MabThera(R) (rituximab) there are
a number of projects in development, potentially allowing Roche to
build on further opportunities. MabThera is the first and only
selective B-cell therapy for RA, providing a fundamentally different
treatment approach by targeting B cells, one of the key players in
the pathogenesis of RA. Actemra is Roche's second novel medicine and
is a humanised monoclonal antibody to the interleukin-6 (IL-6)
receptor, inhibiting the activity of IL-6 , a protein that plays a
major role in the RA inflammation process. Actemra is the result of
research collaboration by Chugai and is being co-developed globally
with Chugai. Additional projects creating a rich pipeline include
compounds in Phase I, II and III clinical trials. Notably,
ocrelizumab, a fully humanised anti-CD20 antibody, is just entering
phase III development for 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 the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3
billion Swiss francs, and the Diagnostics Division posted sales of
8.7 billion Swiss francs. Roche employs approximately 75,000
worldwide 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 at www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
Further information:
- Roche & Autoimmune diseases: www.roche.com/med_events_mb1106
References:
(1) OPTION refers to the tOcilizumab Pivotal Trial in methotrexate
Inadequate respONders
(2) European League Against Rheumatism
(3) 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
(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.
(4) Disease activity is measured by a Disease Activity Score
(DAS), where low disease activity is defined as DAS 28 less than or
equal to 3.2 and  remission is defined as DAS 28 less than or equal
to 2.6
(5) Maini RN, Taylor PC, Szechinski J et al., on behalf of the
CHARISMA Study Group. Double-blind randomised controlled clinical
trial of the interleukin-6 receptor antagonist, tocilizumab, in
European patients with rheumatoid arthritis who had an incomplete
response to methotrexate. Arthritis Rheum. 2006 Sep;54(9):2817-29.

Contact:

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/ e-mail: basel.mediaoffice@roche.com, - Daniel Piller (Head of
Roche Group Media Office), - Katja Prowald (Head of Science
Communications), - Martina Rupp, - Baschi Durr, - Claudia Schmitt. On
site contacts: Roche: Jennifer Wilson, International Communications
Manager, Tel: +41-79-619-1765. Cohn & Wolfe, Jeremy Clark : Tel:
+44-7834308958, Nicole Moores (UK): Tel : +44-207-331-5337

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