Novartis Phase III study shows ACZ885 helped substantially reduce steroid use in 45% of patients with serious form of childhood arthritis
Chronic steroid use to treat the symptoms of systemic juvenile idiopathic arthritis (SJIA) can contribute to slowed growth and delayed puberty
Novartis announced 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 at the American College of Rheumatology's (ACR) Annual Scientific Meeting in Chicago, US.
"These data are very welcome because nearly half of ACZ885-treated patients were able to reduce their steroid use during the study, potentially helping decrease the impact that these drugs can have on this young population," said Dr Nico Wulffraat, one of the study investigators and pediatric immunologist at Wilhelmina Children's Hospital, University Medical Center in Utrecht, The Netherlands. "One of our main goals as physicians, and this applies to all therapies, is to provide patients with treatment options that combine effective control of their disease with a favorable safety profile, making long-term safety data monitoring important."
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).
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 (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.
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