Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis- Multinational Phase III Study Meets Primary Endpoint in Rheumatoid Arthritis Patients Who Failed to Respond to Anti-tumor Necrosis Factor Treatments -
NUTLEY, N.J., July 10, 2007 /PRNewswire/ -- Roche today announced that results from the Actemra Radiate (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) trial successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who failed to respond to anti-tumor necrosis factor treatments (anti-TNFs).
The trial - the third multinational Phase III study of ACTEMRA outside of Japan - showed that a greater proportion of patients treated with ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment, compared to those who were treated with placebo plus methotrexate.
ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arms of the RADIATE trial were nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract infection.
"The study results reconfirm the findings from the previous multinational trials that interleukin-6 receptor inhibition is a novel mechanism for reducing inflammation caused by RA," said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche. "The data demonstrate that ACTEMRA can potentially offer an effective approach in reducing the signs and symptoms of RA, particularly when therapies such as anti-TNFs prove insufficient."
Data from this trial will be submitted for presentation at upcoming national scientific meetings. In addition, other Phase III trials exploring ACTEMRA in RA are ongoing with another study scheduled to report in 2007.
About the RADIATE Study
The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) study is a three-arm, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) compared to placebo plus methotrexate in RA patients who had an inadequate response to anti-TNFs alone. Patients received either ACTEMRA intravenously (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate weekly or placebo infusions every four weeks plus methotrexate weekly.
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 response criteria (3), a measurement of treatment response. The study included 498 patients at 128 trial sites in 13 countries, including the United States.
The RADIATE trial is one of five Phase III clinical studies designed to investigate ACTEMRA as a potential new treatment for RA. Roche and Chugai have initiated the collaborative clinical development program that has enrolled a total of more than 4,000 patients in 41 countries including the United States and several European countries.
About ACTEMRA (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat 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. The global ACTEMRA Phase III clinical development program is designed to evaluate this clinical finding. The compound is not currently approved in the United States.
The most common adverse events reported in ACTEMRA 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.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the 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. Characteristics of RA include redness, swelling, pain, and movement limitation around joints of the hands, feet, elbows, knees and neck that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased hemoglobin and osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 2.1 million people affected in the United States.
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 combines 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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Posted: July 2007