First Actemra multinational phase III trial demonstrates significant improvement in signs and symptoms of rheumatoid arthritis

Study meets primary endpoint in rheumatoid arthritis patients who had an inadequate response to methotrexate

BASEL, Switzerland | Jan 24, 2007 |
Roche announced today that ‘OPTION’1, the first multinational phase III study of Actemra (tocilizumab) outside of Japan, successfully met its primary endpoint in the group of patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate. The study showed that a greater proportion of RA patients treated with Actemra achieved a significant improvement in disease signs and symptoms (ACR scores2) at week 24, compared to methotrexate control. Moreover, the preliminary analysis did not reveal any clinically important safety concerns with Actemra compared to control.

"We are pleased that this study confirms the favourable efficacy and safety profile of Actemra in the treatment of RA. Actemra, through its unique blockade of the interleukin-6 receptor, will provide a new treatment option for people afflicted by rheumatoid arthritis," commented William M. Burns, CEO Division Roche Pharmaceuticals.

Data from this trial will be submitted for presentation at upcoming international scientific meetings. In addition, four other phase III trials exploring Actemra in RA are ongoing with three of them scheduled to report in 2007.

About the OPTION study
The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) study was an international study which took place in 17 countries with 73 centres entering 623 patients with moderate to severe RA. In this 3 arm, randomized, double-blind study, patients received Actemra intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly.

The study found that patients treated with Actemra had a significant reduction in the signs and symptoms of rheumatoid arthritis over 6 months of treatment. Moreover, the preliminary analysis did not reveal any clinically important safety concerns with Actemra compared to control. The study also explored pharmacokinetics and mechanisms of the effect of IL-6 receptor blockade on the immune response in RA patients.

About Actemra
Actemra (tocilizumab) is a new humanised interleukin-6 (IL-6) receptor monoclonal antibody with a novel mechanism of action providing a unique treatment option for RA, a disease with a high unmet medical need. Roche and Chugai have initiated a collaborative 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 (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 (tocilizumab) is another ‘first-in-class’ medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, blocking 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.

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. Roche employs roughly 70,000 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 (

All trademarks used or mentioned in this release are legally protected.

Further information
- Roche & Autoimmune diseases

1) OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders
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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