NUTLEY, N.J., June 15, 2007 /PRNewswire/ -- 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(TM) (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(TM) (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. ACTEMRA(TM) was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA(TM) 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(TM) 8 mg/kg group showed a rapid lowering of CRP levels within two weeks, while fatigue scores showed that patients in the ACTEMRA(TM) 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(TM) 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 ACTEMRA(TM) 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."
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. RA affects more than 21 million people worldwide with approximately 2.5 million people affected in the United States. RA may also shorten life expectancy by affecting major organ systems and after 10 years, less than 50% of patients can continue to work or function normally on a day- to-day basis.
About the Study
The OPTION trial is a three-arm, randomized, double-blind, controlled Phase III study designed to evaluate the safety and efficacy of ACTEMRA(TM) plus methotrexate compared to placebo plus methotrexate in patients with moderate to severe RA who had an inadequate response to methotrexate alon e. Patients received ACTEMRA(TM) intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly, or placebo infusions plus methotrexate weekly, for 24 weeks. The study enrolled patients at 73 trial sites in 17 countries outside the United States, and is one of five Phase III trials designed to study ACTEMRA(TM) as a potential new treatment for RA.
Data from the study were analyzed to determine patients' response to treatment by using three standard assessments: ACR score(1), developed by the of Rheumatology (ACR), DAS28(2), a measurement of RA disease activity, and EULAR(3), a measurement of treatment response.
In the study, 43.9% of patients treated with ACTEMRA(TM) (8mg/kg) plus methotrexate achieved at least a 50% (ACR50) reduction in symptoms compared to 10.8% of patients receiving placebo and methotrexate; ACR70 was achieved in 22% of the treatment group versus 2% in the control group. At 24 weeks, disease remission, as measured by DAS28 (<2.6), was achieved by 28% of patients treated with ACTEMRA(TM) 8mg/kg plus methotrexate compared to 1% of those in the placebo and methotrexate group. At 24 weeks, the difference in the reduction of DAS28 from baseline was greater and statistically significant (p<0.0001) in patients treated with ACTEMRA(TM) 8mg/kg plus methotrexate (-3.43) compared to those in the placebo and methotrexate group (-1.55). According to the EULAR response, a good/moderate response was seen in 79.5% and 61.9% of patients receiving ACTEMRA(TM) plus methotrexate 8mg/kg and 4mg/kg, respectively, compared to 34.8% of patients receiving placebo plus methotrexate.
About ACTEMRA(TM) (tocilizumab)
ACTEMRA(TM) is the first humanized interleukin-6 (IL-6) receptor- inhibiting monoclonal antibody studied for the treatment of RA. Roche and Chugai have initiated a collaborative Phase III clinical development program in RA that is underway outside Japan with more than 4,000 patients have been recruited in 41 countries including several European countries and the USA. The compound is not currently approved in the United States.
The most common adverse events reported in ACTEMRA(TM) global clinical studies are upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other biological disease modifying anti-rheumatic drugs (DMARDs), serious infections have been reported in some patients treated with ACTEMRA(TM).
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
(1) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%, 50% or 70%) in certain RA symptoms and measures the number of tender and swollen joints, pain, patient's and physician's global assessments and certain laboratory markers. An ACR70 response is considered exceptional and represents a significant improvement in a patient's condition. (2) The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combin es information from 28 tender and swollen joints (range 0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28 less than or equal to 3.2), moderate (3.2 < DAS28 less than or equal to 5.1) or high (DAS28 >5.1). DAS28 <2.6 corresponds to being in remission according to the criteria of the American Rheumatism Association (ARA). (3) The EULAR response criteria is based on the individual amount of change in DAS and the DAS value (low, moderate, high disease activity) reached to classify patients as good, moderate and non-responders.
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