The novel rheumatoid arthritis drug Actemra (tocilizumab) has shown superiority over the current standard of care, methotrexate (MTX), by achieving a greater reduction of signs and symptoms (e.g. swollen and tender joints) at 6 months in patients suffering from rheumatoid arthritis. This positive outcome makes Actemra the first and only biologic therapy to have achieved superiority over MTX.

Furthermore, nearly three times as many patients treated with Actemra achieved disease remission the ultimate goal of treatment in this currently incurable condition. The outcome is significant as RA is a debilitating long-term disease and current medicines give little hope of remission or cure - as such new treatment options are urgently needed.

William M Burns, CEO of Roche's Pharma division said, "The latest study data are encouraging news for patients suffering from the devastating effects of rheumatoid arthritis. As the first and only biologic treatment to demonstrate superiority to the current standard of care in early treatment for RA, we believe Actemra will offer more patients relief from their debilitating symptoms. Additionally, Actemra provides patients with a better chance for an early and durable remission".

The Ambition study data, presented at the European League Against Rheumatism (EULAR) congress, was designed to evaluate the efficacy and safety of Actemra (8 mg/kg) compared to MTX in patients with active RA disease. The study showed that significantly more patients receiving Actemra achieved a 20 per cent improvement in their symptoms after 24 weeks of treatment. No previous biologic therapy has demonstrated superiority compared to MTX in this important clinical parameter at Week 24.

In addition, nearly three times as many patients taking Actemra as monotherapy achieved remission compared to those taking MTX. Notably, the patients in Ambition had a shorter disease duration than in prior studies with Actemra. The majority of patients had not received previous therapy with MTX and many had not been treated with any disease-modifying anti-rheumatic drugs (DMARDs).

"We are very encouraged by the results of the Ambition study that shows for the first time that treatment with a single biologic agent is superior to methotrexate at six months of therapy," said Graeme Jones, MD, lead investigator of the Ambition trial and Professor at the University of Tasmania in Hobart, Australia. "Overall, these compelling results further establish the efficacy and safety of Actemra in treating the chronic signs and symptoms of rheumatoid arthritis that dramatically affect the lives of patients".

Radiate Study Shows Actemra Effective in Difficult-to-Treat-Patients, Data from a second Actemra study, the Radiate trial, also presented in Paris and published online this week in the Annals of Rheumatic Diseases, revealed that Actemra is also effective in difficult-to-treat patients who have had an inadequate response to a commonly used class of RA drugs known as anti-TNFs (anti-tumour necrosis factor therapy). Thirty per cent of patients treated with Actemra in combination with MTX achieved disease remission compared with 1.6 per cent f patients who were treated with MTX alone.

The study also showed that significantly more patients on Actemra achieved a reduction in their signs and symptoms following 24 weeks of treatment. What made this result so remarkable was the fact that 12-18 per cent of the study population had failed to respond to three or more prior anti-TNF therapies, leaving them with little hope of further symptom relief from these traditional treatments.

Presenting the data, Professor Paul Emery, arc Professor of Rheumatology, University of Leeds, and Principal Investigator, said, "These study results are very promising for RA patients who need a variety of treatment options, particularly when they have failed to achieve adequate pain and symptom relief with anti-TNF therapies".

Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five phase III trials was designed to evaluate clinical findings of Actemra.