ACTEMRA® (tocilizumab) Studies to be Featured at American College of Rheumatology Annual Scientific Meeting
--Phase III data highlight the benefits of ACTEMRA for rheumatoid arthritis--
Roche today announced that a total of 15 abstracts involving its investigational rheumatoid arthritis (RA) treatment ACTEMRA® (tocilizumab) have been accepted for presentation at the 2008 American College of Rheumatology (ACR) Annual Scientific Meeting, which will take place October 24-29 in San Francisco. These studies evaluate ACTEMRA, a novel treatment targeting interleukin-6 (IL-6) receptors, in patients with moderately to severely active RA.
Platform Presentations/Poster Sessions
· October 27, 2:45 pm - 3:00 pm PDT, Room 307 [Oral Presentation during the RA Treatment: Biologic Efficacy RCT’s session], “Tocilizumab Rapidly and Significantly Improves Outcomes in Patients with Rheumatoid Arthritis Who Have Inadequate Response to TNF Antagonists” (Presenter: Paul Emery, M.D.)
· October 27, 3:00 pm - 3:15 pm PDT, Room 307 [Oral Presentation during the RA Treatment: Biologic Efficacy RCT’s session], “The AMBITION Study: Superiority of Tocilizumab vs. Methotrexate Monotherapy in Patients with Rheumatoid Arthritis” (Presenter: Graeme Jones, M.D.)
· October 28, 3:15 pm - 3:30 pm PDT, Room 307 [Oral Presentation during the ACR Business Meeting and Late-Breaking Abstracts session], “Tocilizumab Inhibits Structural Joint Damage in RA Patients with an Inadequate Response to Methotrexate: The LITHE Study” (Presenter: Joel M. Kremer, M.D.)
· There are 12 additional posters and abstracts highlighting results from the extensive multi-national ACTEMRA clinical development program, which included more than 4,000 patients in 41 countries, including the U.S.
About ACTEMRA (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody being studied for the treatment of RA. Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. Four Phase III studies are completed and have reported meeting their primary endpoints. The fifth Phase III study, the LITHE trial evaluating ACTEMRA in RA is an ongoing two-year study, which is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is under review in the United States and Europe.
ACTEMRA is part of a co-development agreement with Chugai Pharmaceuticals Co. In June 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman’s disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.
The serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in patients; these increases were generally mild and reversible, with no evidence of hepatic injuries. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in patients without association with clinical outcomes. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of malignancies.
IL-6 is a common protein found in all joints in the body and is a natural substance that can raise inflammation. Everyone has IL-6 in their body, but people with RA may have too much. When approved, ACTEMRA will be the first and only medication to specifically target IL-6 in patients with RA.
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, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50 percent of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 1.3 million adults 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 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). For additional information about the U.S. pharmaceuticals business, visit our website: http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.
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