The FINANCUIAL — Novartis announced today new pivotal Phase III data showing 45% of children with active systemic juvenile idiopathic arthritis were able to substantially reduce their use of oral corticosteroids within 28 weeks of commencing treatment with ACZ885.
The results of the study, which met both primary endpoints, will be presented on November 9 at the American College of Rheumatology's Annual Scientific Meeting in Chicago, US[3]In addition, patients with SJIA on ACZ885 were nearly three times 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 support 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 were reported in this study.ACZ885 is an investigational fully human monoclonal antibody which neutralizes the key inflammatory mediator, interleukin-1 beta, which plays an important role in a number of diseases including SJIA.
SJIA is the most serious form of childhood arthritis and affects less than one child per 100,000. 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 flares, which can involve skin rash, daily spiking fevers, joint pain and limited motion. These children can face joint destruction and growth retardation, with serious developmental and psychological consequences.
Therapies traditionally used to treat SJIA can only partially mitigate symptoms and do not normally prevent the long-term damage caused by the disease. Long-term steroid use designed to treat SJIA symptoms can also contribute to slowed growth, delayed puberty and reduced bone density.
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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