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

    - New Data Supports IL-6 Receptor Inhibition as a Key Component in
    Controlling Inflammation From RA

    BASEL, Switzerland, June 15 /CNW/ - 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 remission(4) 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).

    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,
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

    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

    All trademarks used or mentioned in this release are protected by law.

    Further information:

    - Roche & Autoimmune diseases:


    (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

    (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.

For further information:

For further information: Roche Group Media Office, Phone:
+41-61-688-8888, e-mail:, 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:

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