Strong Ph III head-line data for Actemra

Swiss drug major Roche says that the first multinational Phase III study of Actemra (tocilizumab) outside Japan, met its primary endpoint in moderate-to-severe rheumatoid arthritis patients with inadequate response to methotrexate.

The OPTION study showed that a greater proportion of RA patients treated with Actemra achieved a significant improvement in American College of Rheumatology scores for disease signs and symptoms at week 24, compared to methotrexate control. Moreover, the preliminary analysis did not reveal any clinically-important safety concerns with Actemra compared to control, Roche noted.

According to the firm, with its unique blockade of the interleukin-6 receptor, Actemra will provide a new treatment option for people afflicted with RA. Data from this trial will be submitted for presentation at the upcoming European League Against Rheumatism annual congress, to be held in Barcelona, Spain, on June 13-16. In addition, four other Phase III trials exploring Actemra in RA are ongoing with three of them scheduled to report in 2007.