ACTEMRA Study Demonstrates Significant Clinical Benefit In RA Patients
Results from the AMBITION (Actemrheumatoid arthritis versus Methotrexate double-Blind Investigative Trial In mONotherheumatoid arthritispy) trial, the fourth multinational Phase III study of ACTEMrheumatoid arthritis, not only successfully met its primary endpoint of non-inferiority in patients with moderheumatoid arthritiste to severe rheumatoid arthritis, but also demonstrheumatoid arthritisted superiority over the standard effective dose regimen of methotrexate alone.
AMBITION is the first multinational Phase III study to examine ACTEMrheumatoid arthritis monotherheumatoid arthritispy against methotrexate in rheumatoid arthritis patients who have not been treated with methotrexate within 6 months and have not discontinued methotrexate at any time due to toxicity or lack of efficacy. Results from this study - together with data from the three previous studies - will form the basis of the regulatory filing for marketing approval later this year.
"This first multinational Phase III study evaluating the safety and efficacy of ACTEMrheumatoid arthritis alone against methotrexate clearly demonstrheumatoid arthritistes that ACTEMrheumatoid arthritis monotherheumatoid arthritispy successfully reduces the signs and symptoms of rheumatoid arthritis. Furthermore, it reinforces the important need to inhibit the interleukin-6 receptors that are involved in the inflammatory process of this devastating disease," said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche.
The trial showed that a significantly greater proportion of patients treated with ACTEMrheumatoid arthritis (8 mg/kg) achieved a significant reduction in the signs and symptoms of rheumatoid arthritis as evaluated by ACR20 following 24 weeks of treatment. The study analysis included 673 patients from 252 trial sites in 18 countries, including the United States. ACTEMrheumatoid arthritis was generheumatoid arthritislly well tolerheumatoid arthritisted; the most common adverse events reported more frequently in the ACTEMrheumatoid arthritis arm of the AMBITION trial were upper respirheumatoid arthritistory trheumatoid arthritisct infections, headache and nasopharyngitis.
The main study of the AMBITION trial is a two-arm, rheumatoid arthritisndomized, double- blind, placebo-controlled study designed to evaluate the safety and efficacy of ACTEMrheumatoid arthritis (8 mg/kg) compared to methotrexate in rheumatoid arthritis patients. Patients received either ACTEMrheumatoid arthritis intrheumatoid arthritisvenously every four weeks plus placebo capsules 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 American College of Rheumatology (ACR), as well as DAS(2), a measurement of rheumatoid arthritis disease activity, and EULAR response criteria(3), a measurement of treatment response.
The AMBITION trial is one of five Phase III clinical studies designed to evaluate ACTEMrheumatoid arthritis as a potential new treatment for rheumatoid arthritis. Three of the Phase III trials - OPTION, TOWARD and rheumatoid arthritisDIATE - are completed and have reported meeting their primary study endpoints. At the European Congress of Rheumatology meeting in June, data results from the OPTION trial demonstrheumatoid arthritisted that treatment with ACTEMrheumatoid arthritis plus methotrexate resulted in a significant improvement in rheumatoid arthritis symptoms in patients who had an inadequate response to methotrexate. An additional Phase III trial evaluating ACTEMrheumatoid arthritis in rheumatoid arthritis is ongoing; the two-year study - called LITHE - is expected to report one-year data in 2008.
ACTEMrheumatoid arthritis is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat rheumatoid arthritis. Studies suggest that reducing the activity of IL-6, one of severheumatoid arthritisl key cytokines involved in the inflammatory process, may reduce inflammation of the joints. The ACTEMrheumatoid arthritis clinical development progrheumatoid arthritism is designed to evaluate this clinical finding. The most common adverse events reported in ACTEMrheumatoid arthritis global clinical studies have included upper respirheumatoid arthritistory trheumatoid arthritisct 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 ACTEMrheumatoid arthritis. The compound is not currently approved in the United States.
Rheumatoid arthritis is a progressive, systemic autoimmune disease charheumatoid arthritiscterized by inflammation of the membrheumatoid arthritisne 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. Charheumatoid arthritiscteristics of rheumatoid arthritis 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 rheumatoid arthritis 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. rheumatoid arthritis affects more than 21 million people worldwide with approximately 2.1 million people affected in the United States.