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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

ept) or placebo (Period B) and time to disease flare and safety were assessed, and an open-label phase designed to assess efficacy and long-term safety (Period C). Children in periods A and B remained on a stable dose of MTX and children in Period C were permitted one of three DMARDs in addition to ORENCIA. Data from Period C will be presented tomorrow. Results from Periods A and B were presented at the of Rheumatology Annual Scientific Meeting in November 2006.

Fifty-nine children randomized to placebo in Period B participated in Period C to receive open label treatment with ORENCIA. Thirty-three of them experienced a flare while 26 did not.

Everyone in Period C received 10 mg/kg of ORENCIA approximately every 28 days. Of the 33 children who received placebo and experienced disease flares during the Period B protocol-mandated withdrawal phase of up to six months, 80 percent had an ACR Pedi 30 response, 70 percent had an ACR Pedi 50 response, 50 percent had an ACR Pedi 70 Response and 27 percent had an ACR Pedi 90 response after re-introduction of therapy with ORENCIA in Period C.

Of the 26 children who received placebo during Period B who did not experience disease flares and then chose to receive open-label ORENCIA treatment during Period C, 76 percent had an ACR Pedi 30 response, 68 percent had an ACR Pedi 50 response, 60 percent had an ACR Pedi 70 Response and 36 percent had an ACR Pedi 90 response after re-introduction of therapy with ORENCIA in Period C.

Of the children who completed Period C, four (6.7 percent) children previously treated with placebo in Period B reported serious adverse events (SAEs) versus five (5.5 percent) children continuously treated with ORENCIA. All SAEs were considered unrelated to ORENCIA according to the investigator. None of these children discontinued due to an adverse event (AE). In addition, no child previously treated with placebo in Period B had an acute infusion reaction during the first infusion
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