Roche Release: Phase III ACTEMRA(TM) (tocilizumab) Study Results Demonstrate Significant Improvement In Signs And Symptoms Of Patients With Rheumatoid Arthritis
NUTLEY, N.J., Jan. 24 -- Roche today announced that results from the OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial, the first international Phase III study of ACTEMRA(TM) outside of Japan, successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate, a current standard of care. The study showed that a greater proportion of RA patients treated with ACTEMRA(TM) (either 4mg/kg or 8mg/kg) plus methotrexate achieved a significant improvement in disease signs and symptoms (ACR20) at week 24, compared with placebo plus methotrexate.
The preliminary analysis demonstrated that the safety profile of ACTEMRA(TM) was consistent with earlier development studies; the most common side effects reported in the study were upper respiratory tract infection and headache. There was a similar incidence of infection reported across treatment arms.
"We are pleased that this study confirms the favorable activity of ACTEMRA(TM) in the treatment of RA," said Lars Birgerson, MD, PhD, Vice President, Medical Affairs, Roche. "Through its unique blockade of the interleukin-6 receptor, ACTEMRA(TM) may offer a novel approach to reduce the debilitating symptoms of RA and help patients who may not be achieving sufficient relief from standard therapies like methotrexate."
Data from this trial will be submitted for presentation at upcoming international scientific meetings. In addition, four other Phase III trials exploring ACTEMRA(TM) in RA are ongoing with three of them scheduled to report in 2007.
About the OPTION Study
The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) study is a three-arm, randomized, double-blind, controlled study designed to evaluate the safety and efficacy of ACTEMRA(TM) plus methotrexate compared to placebo plus methotrexate in RA patients who had an inadequate response to methotrexate alone. Patients received ACTEMRA(TM) intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. Patients' response was measured using ACR, a standard assessment developed by the American College of Rheumatology to measure the signs and symptoms of RA. A 20% reduction in the signs and symptoms of RA is represented as ACR20. The study enrolled 623 patients at 73 trial sites in 17 countries outside the United States.
The OPTION study is one of five Phase III trials underway to study ACTEMRA(TM) 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(TM) (tocilizumab)
ACTEMRA(TM) is the first humanized interleukin-6 (IL-6) receptor-blocking monoclonal antibody with a novel mechanism of action. 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 anemia, fatigue and osteoporosis. The ACTEMRA(TM) clinical development program is designed to evaluate these questions. The compound is not currently approved in the United States.
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, anemia 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.
About Roche
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, the Roche Group 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 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.