Investor Update
Basel, 2 October 2008
Actemra significantly improves the debilitating symptoms of Rheumatoid Arthritis in patients who do not adequately respond to standard therapies
Third pivotal phase III study, TOWARD, published in the October issue of Arthritis and Rheumatism
The innovative rheumatoid arthritis drug Actemra (tocilizumab) has been shown to significantly improve the signs and symptoms of rheumatoid arthritis (RA) in patients who failed to achieve an adequate response to traditional disease modifying agents (DMARDs), according to a study published in this month’s issue of Arthritis and Rheumatism.
The TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) trial demonstrated that more RA patients not only achieved greater improvement of symptoms, but also went into disease remission, (a halt of disease as defined by the globally recognised measure of DAS28 <2.6) with Actemra in combination with standard DMARDs, compared to those treated with DMARDs alone. 30% of patients in the Actemra arm of the trial achieved clinical remission at week 24 versus 3% of patients in the DMARDs only group.
Levels of inflammation markers such as C-reactive protein (CRP) decreased significantly in the Actemra group versus the group receiving DMARDs only. Normalization of mean CRP levels and an increase in hemoglobin levels was seen as early as within two weeks in patients treated with Actemra plus DMARDs. Moreover, 60% of patients in the Actemra group had a clinically meaningful improvement in physical function at week 24, compared with 34% in the DMARDs only arm of the study.
The TOWARD study is part of an extensive clinical development program of five Phase III trials that was designed to evaluate clinical findings of Actemra. All five studies have reported meeting their primary endpoints.
Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis, and increased risk of cardio-vascular disease and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.
About TOWARD Study
The TOWARD trial, a two-arm, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of Actemra plus DMARDs compared to placebo plus DMARDs in RA patients. Patients were randomized to receive either Actemra intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The multicentre study treated 1,216 patients at 130 trial sites in 18 countries, including the U.S.
At 24 weeks, significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28 <2.6) compared to 3 % of patients treated with only DMARDs.
No new safety signals were detected compared to previous trials.
About Actemra
Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of Actemra. The five studies have reported meeting their primary endpoints. In Japan, Actemra was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.
Actemra is generally well tolerated. The overall safety profile of Actemra is consistent across all global clinical studies. 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 and hypertension. 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.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
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