Phase 3 Study of ACZ885 for Children with Systemic Juvenile Idiopathic Arthritis
Novartis announced data from its Phase 3 study of ACZ885 (canakinumab) for the treatment of children with active systemic juvenile idiopathic arthritis (SJIA). The 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. The primary endpoints were to assess if ACZ885 allows tapering of steroids in at least 25% of SJIA patients (Part I); and to demonstrate that time to next flare is extended with ACZ885 vs. placebo (Part II).
The results showed 45% of children with SJIA were able to substantially reduce their use of oral corticosteroids within 28 weeks of commencing treatment with ACZ885 (P<0.0001). 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).
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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