Roche has announced significant results from 'Option'1, the first rheumatoid arthritis multinational phase III study of Actemra (tocilizumab) outside of Japan. The data presented at the EULAR2 meeting in Barcelona, Spain, showed that patients who received Actemra in combination with methotrexate achieved rapid and significant improvement in their signs and symptoms of rheumatoid arthritis when compared to patients receiving methotrexate alone.
In the 24-week study, four times the number of patients in the Actemra group experienced 50 per cent improvement in disease symptoms (ACR503 response) compared to the control group (44% vs 11%). More than ten times the number of Actemra patients achieved 70 per cent improvement in disease signs and symptoms (ACR70 response) compared to the control group (22.0% vs 2.0%). In addition, 28 per cent of patients achieved the ultimate goal of remission4 in the Actemra group vs only 1 per cent of patients in the control group.
"The efficacy of IL-6 receptor inhibition in this study confirms the critical role of IL-6 in the causal pathways of rheumatoid arthritis. On this basis, the profound clinical success observed with tocilizumab by targeting a novel pathway is extremely encouraging as is the opportunity for rheumatoid arthritis patients to benefit from a potential new treatment option," commented lead investigator, Professor Josef Smolen.
"The detailed data from the Option study, together with the first data from the Toward study announced last week, show a great benefit for rheumatoid arthritis patients. We look forward to further results from our extensive multinational phase III development programme later this year," commented William Burns, CEO Division Roche Pharmaceuticals.
Other parameters measured included C-reactive protein (CRP), a marker of inflammation, fatigue and haemoglobin. Patients in the 8mg/kg Actemra group showed a rapid normalisation of the CRP levels within 2 weeks while fatigue scores showed that patients in the Actemra group experienced a reduction in fatigue and a rapid improvement in haemoglobin levels. Low levels of haemoglobin are usually associated with anaemia which makes patients feel tired and lacking in energy.