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Novartis Phase III Study Shows ACZ885 Helped Substantially Reduce Steroid Use in 45% of Patients With Serious Form of Childhood Arthritis
Date:11/6/2011

EAST HANOVER, N.J., Nov. 7, 2011 /PRNewswire/ -- Novartis announced today new pivotal Phase III data showing 45% of children with active systemic juvenile idiopathic arthritis (SJIA) were able to substantially reduce their use of oral corticosteroids (often described as steroids) within 28 weeks of commencing treatment with ACZ885 (canakinumab) (p<0.0001)[1].

The results of the study, which met both primary endpoints, will be presented on November 9th at the American College of Rheumatology's (ACR) Annual Scientific Meeting in Chicago, US[1].

"The treatment of SJIA is a challenge given our current treatment options. Despite our best efforts, optimal disease control is often times elusive. We still must use steroids in the treatment of these children with SJIA. Steroids help manage many SJIA symptoms, such as fever and inflammation, but doctors try to minimize their use because of the potential negative impact on bones and growth," said Daniel Lovell, M.D., one of the study investigators and Professor of Pediatrics at the Cincinnati Children's Hospital Medical Center. "These data are exciting because they show that patients on ACZ885 were able to reduce their steroid use, and also experienced excellent disease control."

In addition, patients with SJIA on ACZ885 were nearly three times (0.37 hazard ratio) less likely to suffer a new flare. Therefore, only 27% of ACZ885-treated patients experienced a new flare, vs. 75% of patients on placebo during the study (p=0.0043)[1].

Data from this trial supports the safety and efficacy profile of ACZ885 in the study population. These results, along with data from a second pivotal study, are planned to form the basis for worldwide regulatory submissions in 2012. Side effects observed in this study were similar to those already seen for ACZ885's approved indication, including infections and neutropenia[1]. In addition, cases of macrophage activation syndrome (MAS) were reported in this study[1]
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