"These data demonstrate the significant benefits that ACZ885 may provide this young population, both in steroid reduction and in extending the period these children can live free from SJIA flares," said David Epstein, Head of the Pharmaceuticals Division of Novartis. "Novartis is committed to helping improve the health of patients with SJIA and other inflammatory diseases, which is why we are delighted to be sharing these results."
ACZ885 is an investigational fully human monoclonal antibody which neutralizes the key inflammatory mediator, interleukin-1 beta (IL-1 beta), which plays an important role in a number of diseases including SJIA.
The incidence of SJIA is estimated to be less than 1 in 100,000 children. It is called 'systemic' because the inflammation affects the whole body, as well as most of the joints. The condition is characterized by potentially life-long, recurrent and painful arthritis flares, skin rashes and daily spiking fevers,.
Novartis is also presenting a number of other studies at ACR, including a second pivotal Phase III trial of ACZ885 in SJIA, which was previously presented at the 2011 European Pediatric Rheumatology Congress in Bruges, Belgium, in September.
About the StudyThe Phase III, two-part study had an open-label, single-arm active treatment in Part I followed by a randomized, double-blind, placebo-controlled, event-driven withdrawal design in Part II. A total of 177 patients between the ages of 1 and 19 years with active SJIA were enrolled in the study. In Part I, patients received a subcutaneous (s.c.) dose of ACZ885 (4 mg/kg, up to 300 mg) every 4 weeks. After 8 weeks, patients who met the adapted ACR Pediatric 30 criteria began tapering (reducing) their steroid use until either: a) the dose had been decreased to less than or equal to 0.5 mg/kg while maintaining the adapted ACR Pediatric 30 Criteria (successful tapering of steroids); or b)
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