The Swiss drug maker compared the efficacy and safety of Actemra monotherapy to the standard methotrexate treatment in rheumatoid arthritis patients.
After 24 weeks of treatment, the Actemra patient group showed significant improvement in disease symptoms.
Actemra is different from other treatments for rheumatoid arthritis in that it is a humanized monoclonal antibody, the first of its type to inhibit the interleukin-6 receptor, which plays a large role in producing inflammation.
Roche-owned Japanese pharma company Chugai Pharmaceutical developed Actemra, which is also known as tocilzumab. Outside Japan, Roche owns the rights to market the drug.
On the basis of this study, and data from three previous international studies, Roche now plans to file Actemra for regulatory approval in the US and Europe by the end of 2007.