Roche announces ‘successful’ Actemra trial

Roche has announced that Actemra (tocilizumab) has reached its primary endpoint in a phase III clinical study involving patients with rheumatoid arthritis (RA) who have exhibited an inadequate response to methotrexate.

The tocilizumab pivotal trial in methotrexate inadequate responders (Option) trial showed that a greater percentage of patients with RA had improved ACR scores measuring improvement in symptoms compared to the control group.

Furthermore, no safety concerns regarding the compound were aroused compared to the control in the trial.

Actemra is a novel interleukin (IL-6) receptor monoclonal antibody with an innovative action mechanism. Phase III clinical trials have been initiated worldwide by Roche and Chugai following the product’s launch in Japan as a treatment for Castleman’s disease in June 2005.

William M Burns, chief executive officer of Roche Pharmaceuticals, said: “We are pleased that this study confirms the favourable efficacy and safety profile of Actemra in the treatment of RA.”

He added that the compound’s unique receptor-blocking mechanism would offer a new treatment option for patients with RA.

In July 2006, Roche announced that MabThera (rituximab) had been approved for use in the EU for the treatment of RA. The compound is indicated for the treatment of RA in conjunction with methotrexate.