- Fifth International Phase III Study Shows Positive Results with X-ray
NUTLEY, N.J., May 9 /PRNewswire/ -- Roche today announced one-year results from a new two-year Phase III study showing that ACTEMRA(TM) (tocilizumab) can significantly inhibit progression of structural damage to joints in patients with rheumatoid arthritis (RA), a critical measure of effectiveness of an RA treatment. The study also demonstrated that ACTEMRA reduces disease signs and symptoms at one year. The LITHE study is the fifth international Phase III ACTEMRA trial to successfully meet its primary endpoints in patients with moderate to severe RA.
The one-year data from LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) trial showed that a greater proportion of patients treated with ACTEMRA (4 mg/kg or 8 mg/kg) plus methotrexate versus placebo plus methotrexate over 52 weeks achieved a significant reduction in the progression of structural joint damage, which is critical to RA patients because joint damage leads to disability. The study analysis included 1,196 patients from 137 trial sites in 15 countries. Twenty-eight percent of the patients were from the United States.
ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arm of the LITHE trial were upper respiratory tract infections, nasopharyngitis, hypertension, headache and an increase in transaminases.
"At one year, the results from the LITHE trial clearly demonstrate that ACTEMRA could be an effective component in the battle against the long-term debilitating effects of RA, including joint damage and loss of physical function," said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche. "The ACTEMRA clinical development program was designed to establish ACTEMRA as a first-line biologic in the treatment of RA. When you consider that this is the fifth consecutive successful Phase III trial for ACTEMRA across multiple patient populations, it is an exciting day for RA patients, the science of RA and for Roche."
About the LITHE Trial
The LITHE trial is a three-arm, randomized, double-blind, placebo- controlled study designed to evaluate the safety and efficacy of ACTEMRA (4 mg/kg or 8 mg/kg) combined with methotrexate compared to placebo with methotrexate in RA patients. Patients received either ACTEMRA intravenously every four weeks plus methotrexate weekly or placebo infusions every four weeks plus methotrexate weekly.
The study analyzed patients' response to treatment by measuring structural damage in the joints through X-rays; disease activity was measured through standard assessments such as the ACR score(1), developed by the American College of Rheumatology (ACR). The study also examined improvement in physical function through the Health Assessment Questionnaire (HAQ).
The LITHE trial is one of five Phase III clinical studies designed to evaluate ACTEMRA as a potential new treatment for RA across multiple patient populations. Four of the Phase III trials - OPTION, TOWARD, RADIATE and AMBITION - are completed and have reported meeting their primary study endpoints. Data from all four trials will be presented at the upcoming European Congress of Rheumatology (ECR) held by the European League Against Rheumatism (EULAR) in Paris (June 11-14).
About ACTEMRA(TM) (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. 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 and relieve 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 40 countries, including the United States. Four studies are completed and have reported meeting their primary endpoints. The LITHE trial evaluating ACTEMRA in RA is an ongoing two-year study and is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is awaiting approval in the United States and Europe.
ACTEMRA is part of a co-development agreement with Chugai, a Japanese company. In April 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman's disease; in April 2008, ACTEMRA was approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis in Japan.
The serious adverse events reported in ACTEMRA clinical trials were serious infections and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache and hypertension. Increases in liver function tests (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.
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. If approved, ACTEMRA will be the first and only medication to specifically target IL-6 inhibition 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.
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Contacts: Ginny Valenze
(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.
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