Friday, drug maker Bristol-Myers Squibb Co. (BMY), announcing the results of two studies on its anti-rheumatic drug, Orencia, said that a first study demonstrated consistent safety and effectiveness over a 7-year period, while a second trial proved the drug's long-term inhibition of structural damage progression over a 5-year period. The results were presented at the 2009 Annual European Congress of Rheumatology, or EULAR, currently being held in Denmark.
Orencia, or abatacept, is a selective co-stimulation modulator of T-cell activation, designed to prevent full T-cell activation and inhibit the release of chemicals that lead to joint inflammation and destruction as commonly observed in the systemic, chronic, autoimmune disease rheumatoid arthritis, or RA.
Rheumatoid arthritis is characterized by inflammation in join linings, causing joint damage with chronic pain, stiffness, and swelling and leads to limited range of motion and decreased function due to the affected joints losing their shape and alignment.
The first, Phase IIb 100 trial (7 years) study, a long-term extension, or LTE, trial, analyzed Orencia's safety and efficacy profile for over 7 years of treatment in RA patients who have had an inadequate response to methotrexate, or MTX.
The company noted that in the long-term extension trial, the Orencia-MTX combine treatment was generally well tolerated, with no increase in the frequency of safety events over time, with the data being consistent with previous data on the Orencia-MTX combine treatment. After 7 years, over half of the patients remained on treatment.
Professor René Westhovens of the University Hospital Leuven in Belgium said, "The relevance of these long-term data should not be underestimated for a chronic and progressive disease such as rheumatoid arthritis. These patients have to live with the disease, and in many cases, undergo treatment, for the rest of their lives. For both patients and clinicians therefore, it is important that a treatment has a proven long-term safety and efficacy profile."
The company also noted that as part of a comprehensive clinical trial program, Orencia's safety profile has already been studied through over 10,000 patient years of exposure, with the new data reinforcing further that the Orencia-MTX combine to be a proven treatment option for moderate to severe active RA in adults who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs.
The second, AIM, or Abatacept in Inadequate responders to Methotrexate (5 years), LTE study further reinforces the long-term safety and efficacy profile of Orencia, the company stated. In this study, Orencia patient retention rates remained high, with 70.4% of patients remaining on the Orencia-MTX combine treatment at year 5.
Also, X-ray data from the AIM LTE demonstrated that over 5 years, Orencia inhibited structural damage progression in the majority of patients on treatment. The company noted that 45.1% of patients assessed at year 5 continued to show no progression in structural damage, with 98% of patients who were non-progressors during years 1-4 remained non-progressors at year 5.
BMY closed Thursday's regular trading session on NYSE at $20.00, up $0.59, with a volume of 17.68 million shares.
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