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

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

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

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, 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.

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

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

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

Further information:

• Roche & Autoimmune diseases: www.roche.com/med_events_mb1106

• 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

References:

Inadequate respONders

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.

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

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.

SOURCE: Roche

CONTACT: Jennifer Wilson,

International Communications Manager of Roche,

+41-79-619-1765;

Daniel Piller (Head of Roche Group Media Office),

Katja Prowald (Head of Science Communications),

Martina Rupp,

Baschi Durr,

Claudia Schmitt,

+41-61-688-8888,

[email protected] ,

all of Roche Group Media Office; or

Jeremy Clark,

+44-7834308958, or

Nicole Moores (UK),

+44-207-331-5337,

both of Cohn & Wolfe

Web sites: http://www.roche.com

http://www.roche.com/med_events_mb1106

--Distributed by AsiaNet ( www.asianetnews.net )--

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