ACTEMRA™ (tocilizumab) Significantly Improves Symptoms of Rheumatoid Arthritis Compared to A Current Standard of Care

Results of the OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial, the first multinational Phase III study outside of Japan, showed that patients treated with ACTEMRA™ (either 4mg/kg or 8mg/kg) plus methotrexate achieved a significant and clinically important improvement in the signs and symptoms of moderate to severe rheumatoid arthritis (RA) compared to patients treated with placebo and methotrexate, a current standard of care. The data were presented today at the European Congress of Rheumatology (ECR) held by the European League Against Rheumatism (EULAR) in Barcelona, Spain.

In the 623-patient study, 58.5% of patients receiving the combination of ACTEMRA™ (8mg/kg) and methotrexate achieved at least a 20% improvement (ACR20) in RA symptoms compared with 26.5% of patients receiving placebo plus methotrexate after 24 weeks. The data also showed that 79.5% of patients in the ACTEMRA™ (8mg/kg) plus methotrexate group responded with moderate to good improvements in RA symptoms (EULAR response) compared to 34.8% for those treated with placebo and methotrexate at 24 weeks. ACTEMRATM was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRATM arms of the OPTION trial were upper respiratory tract infection, nasopharyngitis and headache.

Other parameters measured in the study included C-reactive protein (CRP), a marker of inflammation, fatigue and hemoglobin. Patients in the ACTEMRA™ 8 mg/kg group showed a rapid lowering of CRP levels within two weeks, while fatigue scores showed that patients in the ACTEMRA™ group experienced a reduction in fatigue and a rapid improvement in hemoglobin levels. Low levels of hemoglobin are usually associated with anemia (reduction in red blood cells) that can result in tiredness and fatigue.

“There is a critical need for new therapies to treat moderate to severe RA patients, and these results suggest that IL-6 inhibition is an encouraging anti-inflammatory mechanism for reducing disease symptoms,” said Mark C. Genovese, M.D., Associate Professor of Medicine at Stanford University School of Medicine.

ACTEMRA™ is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action for the treatment for RA. Studies suggest that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints, prevent long-term damage and relieve certain systemic effects of RA such as decreased hemoglobin, fatigue and osteoporosis.

“These study results underscore the potential for ACTEMRATM to become a new treatment option for RA,” said Lars Birgerson, M.D., Ph.D., Vice President, Global Head Medical Affairs, Roche. “We are hopeful that the ongoing Phase III trials will translate into improved clinical outcomes for patients.”