Actemra in monotherapy shows superiority to conventional disease modifying anti-rheumatic drugs (DMARDs) in inhibiting radiographic progression of joint destruction, according to the results of Roche's first Phase III study in rheumatoid arthritis (RA) conducted by Chugai in Japan. The data also show Actemra dramatically improves the painful and disabling symptoms of patients with rheumatoid arthritis.
Actemra (tocilizumab) is a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody that offers a novel mechanism of action and may become a new therapeutic option for the treatment of RA.
Roche and Chugai are developing Actemra in collaboration with Osaka University. This co-development partnership was set up under the first licensing agreement between the two companies in 2003, where Roche was granted the right to promote in all countries except Japan, South Korea and Taiwan, and the parties would co-promote in the UK, France and Germany.
"These data show the progression of patients' joint damage is substantially reduced over the one year period. Furthermore, the important role of IL-6 blockade is highlighted by the clinical benefits experienced in this Actemra monotherapy study. Following these impressive results, we look forward to the outcome of the large phase III programmes currently being run in Europe and the US with Actemra in combination with other anti-rheumatic drugs," commented Dr. Eduard Holdener, Head of Global Pharma Development, Roche.
The overall incidence of adverse events including laboratory abnormalities was 96% and 87% in the Actemra and DMARDs control arms respectively. While lipid increases were reported in the Actemra group, the mean cholesterol level stabilized around the upper limit of normal. No tuberculosis was observed and Actemra monotherapy was generally well tolerated.
Phase II studies have been completed in Japan and Europe. Collaborative phase III clinical development in RA has been completed by Chugai in Japan and is underway outside Japan with more than 4000 patients expected to be enrolled in over 20 countries including several European countries and the USA.