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Roches Actemra Rheumatoid Arthritis Drug Shows Substantial Benefits For Patients In OPTION Study



20 Jun 2007

New data supports IL-6 receptor inhibition as a key component in controlling inflammation from RA.

Roche today 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% 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% improvement in disease signs and symptoms (ACR70 response) compared to the control group (22.0% vs 2.0%). In addition, 28% of patients achieved the ultimate goal of remission4 in the Actemra group vs only 1% 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.

About the OPTION study

The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) study was an international study involving 623 patients with moderate to severe RA. In this 3-arm, randomized, double-blind study, patients received tocilizumab intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly over a period of 6 months.

Although higher efficacy was established at the higher dose (ACR20, 50 and 70 scores of 59%, 44% and 22% respectively in the 8mg/kg Actemra group), patients treated with the lower dose of Actemra (4mg/kg) achieved ACR20, 50 and 70 scores of 48%, 32% and 12% respectively. Furthermore there was a reduction in the Disease Activity Score (DAS) from week 2 onwards for both the 8mg/kg (-3.43) and 4mg/kg (-2.68) Actemra groups compared to control (-1.55). Remission of disease was demonstrated in 28% of patients treated with 8mg/kg of Actemra and methotrexate vs 14% of patients treated with 4mg/kg of Actemra and methotrexate vs 1% or patients receiving methotrexate alone.

Actemra was generally well tolerated with an adverse event (AE) profile consistent with data reported in previous studies5.






About Actemra

Actemra is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. Roche and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.

About rheumatoid arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.

All trademarks used or mentioned in this release are protected by law.References:

References

1) OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate responders

2) European League Against Rheumatism

3) The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20%, 50% or 70% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.

4) Disease activity is measured by a Disease Activity Score (DAS), where low disease activity is defined as DAS 28 ≤ 3.2 and remission is defined as DAS 28 ≤ 2.6

5) Maini RN, Taylor PC, Szechinski J et al., on behalf of the CHARISMA Study Group. Double-blind randomised controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006 Sep;54(9):2817-29.

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