Roche has announced that Toward, 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 score 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 per cent 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.
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.