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U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
Date:4/8/2008

rheumatoid factor (RF) positive) and Systemic JIA with polyarticular course (20 percent) who had not responded adequately to other JIA therapies. In the first phase of this study (Period A), a total of 190 patients aged six to 17 years, with disease duration of approximately four years with moderately to severely active disease at study entry, were enrolled in this open-label, four-month, lead-in phase of the study. The majority (70 percent) of these study patients were new to biologic treatments. Nearly 30 percent of patients had previously had an inadequate response to a TNF antagonist or anakinra. Patients received ORENCIA(R) (abatacept) intravenously (10 mg/kg; maximum 1,000 mg) on Days 1, 15, 29 and every month thereafter. Response was assessed utilizing the ACR Pediatric 30 definition of improvement, defined as greater than or equal to 30 percent improvement in at least three of the six JIA core set variables and greater than or equal to 30 percent worsening in not more than one of the JIA core set variables.

In Period A of the study, ORENCIA demonstrated consistent improvement in ACR Pedi 30 with similar responses across all JIA subtypes (Oligoarticular extended, 59.3 percent; Polyarticular-RF positive, 68.4 percent; Polyarticular-RF negative 64.3 percent; and Systemic JIA with polyarticular course, 64.9 percent). In patients who were inadequate responders to DMARDs including MTX and were new to biologic treatment, ORENCIA demonstrated meaningful ACR Pedi response rates with 76 percent of patients achieving an ACR Pedi 30 response rate, 60 percent achieving an ACR Pedi 50 response rate, 36 percent achieving an ACR Pedi 70 response rate and 17 percent achieving an ACR Pedi 90 response rate. In patients who received prior biological treatment, 38.6 percent achieved an ACR Pedi 30 response rate, 24.6 percent achieved an ACR Pedi 50 response rate, 10.5 percent achieved an ACR Pedi 70 response rate and 1.8 percent achieved an ACR Pedi 90 response rate.


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SOURCE Bristol-Myers Squibb Company
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