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Actemra: New data confirms significant improvement of disease signs and symptoms in patients with rheumatoid arthritis


Second multinational phase III study provides further evidence of the significant role of IL-6 receptor inhibition in the treatment of rheumatoid arthritis

Roche announced today that TOWARD1, the second multinational phase III Actemra (tocilizumab) study, successfully reached its primary endpoint and showed that a greater proportion of patients treated with Actemra in combination with traditional disease modifying drugs (DMARDs) achieved a significant improvement in disease signs and symptoms at week 24, compared to the those treated with DMARDs alone. The patients’ symptoms were measured using the standard ACR score2 assessment method. The patients enrolled in the study had active, moderate to severe rheumatoid arthritis (RA) and had experienced an inadequate response to DMARDs.

“The TOWARD trial data further documents the efficacy and safety of Actemra and the value of its IL-6 receptor inhibition. We look forward to further results from this extensive multinational Phase III development programme,” commented William Burns, CEO Division Roche Pharmaceuticals.

The TOWARD trial included approximately 40% of patients from the United States and data from this trial will be submitted for presentation at international scientific meetings later this year and in 2008. TOWARD is the second of a programme of five phase III clinical trials running on Actemra, with two other trials due to report later in 2007. In January 2007 Roche reported that OPTION3, the first of the phase III trials outside Japan, had successfully met its primary endpoint in patients who had an inadequate response to methorexate.

About the TOWARD study
The TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) study was an international study treating 1216 patients with moderate to severe RA. The study was conducted at 130 study sites in 18 countries, including the USA. In this 2 arm, randomized, double-blind study, patients received either 8mg/kg Actemra intravenously every 4 weeks or placebo in combination with stable anti-rheumatic therapy, including traditional DMARDs but excluding biologics. A greater proportion of patients treated with Actemra in combination with traditional DMARDs achieved a significant improvement in disease signs and symptoms at week 24, compared to those treated with DMARDs alone. The study also explored pharmacokinetics, immune response and pharmacodynamic parameters of Actemra in this patient population.

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.


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