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Abatacept in Combination With Methotrexate Approved in EU for Polyarticular Juvenile Idiopathic Arthritis NEW YORK -- January 25, 2010 -- The European Commission has approved abatacept (Orencia) in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients aged 6 years and older who have had an insufficient response to other disease-modifying antirheumatic drugs (DMARDS), including at least one tumour necrosis factor(TNF)-inhibitor. The approval was based on findings from the double-blind, randomised controlled Abatacept Withdrawal Study to Assess Efficacy and Safety in Key Endpoints in Juvenile Idiopathic Arthritis Not Responding to Current Treatment (AWAKEN) which evaluated the efficacy and safety of abatacept in patients aged 6 to 17 years with moderate to severe active pJIA who had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. AWAKEN studied abatacept in pJIA in 3 phases. The first (period A) was an open-label, lead-in period where patients received active treatment with abatacept; the second (period B) was the double-blind period where patients who had demonstrated an American College of Rheumatology (ACR) Paediatric (Pedi) 30 response were randomised to either abatacept or placebo treatment; and the third (period C) was the open-label extension period open to those patients experiencing flare or completing period B as well as non-responders from period A. In period A, abatacept demonstrated meaningful ACR Pedi response rates, with 65%, 49%, and 28% of patients achieving an ACR Paediatric 30, 50, and 70, respectively. ACR Pedi responses throughout the study (all phases) remained consistent for 1 year and were higher in biologic naïve patients compared with those previously receiving biologic therapy. In period B, patients on abatacept experienced significantly fewer disease flares versus placebo (20% vs 53%, respectively; P = .0003). The risk of disease flare among patients continuing on abatacept was less than one-third than that for patients who withdrew from abatacept treatment. In the lead-in open-label period (period A), during which all patients were given abatacept, the overall frequency of adverse events was 70%; infections occurred at a frequency of 36%. The infections had a typical course and resolved with treatment. No opportunistic infections were recorded. During the double-blind period (period B), the frequency of adverse events did not significantly differ between the treatment group (62%) and placebo (55%; P = .47); 3 serious adverse events were reported for 2 patients, both in the placebo group (P = .50). During periods A, B and C, acute infusion-related events occurred at a frequency of 4%, 2% and 3%, respectively, and were consistent with the types of events reported in adults. SOURCE: Bristol-Myers Squibb E-mail this page to a friend or colleague! To print, use this version