New data from Novartis' ACZ885 Phase III study on SJIA

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).

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.

"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.

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. In addition, cases of macrophage activation syndrome (MAS) were reported in this study.

"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.



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