Roche has announced 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.
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.