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Investigational Study Demonstrated a Re-Establishment of Clinical,Improvement with Orencia (Abatacept) in Children with Juvenile,Idiopathic Arthritis upon Re-Introduction of Therapy

BARCELONA, Spain, June 15, 2007 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company today announced results regarding the efficacy and safety of ORENCIA(R) (abatacept) from the open-label phase of an ongoing investigational study in children with juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying anti- rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists. The results demonstrated that, after a study protocol- mandated withdrawal period of up to six months, the re-introduction of ORENCIA was associated with a re-establishment of clinical improvement as measured by the of Rheumatology's Pediatric (ACR Pedi) criteria for improvement in children with JIA. The data will be presented tomorrow at the Annual Congress of the European League Against Rheumatism.

"Children with JIA can have long periods of inactive disease and clinical remission, which makes it important to study the efficacy and safety of re- starting a treatment after a withdrawal period," said Edward H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, OH, co-principal investigator of the study. "The results of this investigational study suggest that, in these children with JIA who had disease flares while taking placebo during the mandated withdrawal phase, resuming therapy with ORENCIA was associated with a re-establishment of clinical improvement."

The study, designed to assess the efficacy, safety and tolerability of ORENCIA in children and adolescents (ages 6-17 years) with JIA, consisted of three periods: a four-month open-label lead-in treatment period in which all participants received ORENCIA and both a clinical response and safety were assessed (Period A), a six-month randomized double-blind withdrawal phase where responders received either ORENCIA(R) (abatac
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