BMS ANNOUNCES RESULTS FROM PEDIATRIC TRIAL OF ORENCIA
Bristol-Myers Squibb (BMS) has announced results of the double-blind phase of an ongoing study, which show Orencia (abatacept) demonstrated improvement in children with active juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate or TNF antagonists, as measured by the ACR's Pediatric (ACR Pedi) criteria for improvement of JIA. In addition, no child receiving Orencia during the six-month double-blind phase had a serious adverse event or discontinued due to an adverse event. The data were presented at the American College of Rheumatology annual scientific meeting.
The study, designed to assess the efficacy and safety of Orencia in children and adolescents (ages 6 to 17 years) with a mean age of 12.4 years with JIA, consists of three phases: a four-month treatment period in which all participants received Orencia (Part A); a six-month, randomized, double-blind phase where responders received either Orencia or placebo (Part B); and an open-label phase designed to assess long-term safety and efficacy (Part C). Results from Part A and B were presented recently.
In Part A, 190 children and adolescents with JIA, 72 percent of whom were female, who had inadequately responded to one or more DMARDs received Orencia (10 mg/kg IV; maximum 1,000 mg). Of the 190 participants, 123 (64.7 percent) had an ACR Pedi 30 response; 49.5 percent had an ACR Pedi 50 response and 28.4 percent had an ACR Pedi 70 response.
In Part B, 122 of the 123 participants who achieved an ACR Pedi 30 response in the first phase were randomized in a 1-1 ratio to receive double-blind therapy with either Orencia or placebo every 28 days for up to six months. The primary objective of the study was time to disease flare. Of the 122 participants, a total of 33 out of 62 (53.2 percent) of the children receiving placebo experienced disease flares compared to 12 out of 60 (20 percent) receiving Orencia.
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