Novartis announced the results of two Phase 3 trials which showed ACZ885 (canakinumab) provided substantial symptom relief in young patients with systemic juvenile idiopathic arthritis (SJIA). ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta.
Beta-SPECIFIC 1 was a 4-week, randomized, double-blind, placebo-controlled study that involved 84 patients aged 2–19 years with active SJIA. The primary endpoint was the proportion of patients achieving the JIA ACR 30 response criteria, defined as 30% improvement in at least three of the six variables, worsening of more than 30% in no more than one of the criteria, and resolution of fever, from baseline at Day 15. In this trial, 84% of SJIA patients treated with ACZ885 experienced at least a 30% improvement in symptoms compared to 10% for placebo after 15 days of treatment, which was sustained after 29 days (P<0.001).
Beta-SPECIFIC 2 was a two-part study which included 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. A total of 177 patients aged of 2–19 years with active SJIA were enrolled in the study. The primary endpoints were to: a) assess if ACZ885 allows tapering of corticosteroids in at least 25% of SJIA patients (Part I); and b) demonstrate that time to flare is extended with ACZ885 vs. placebo (Part II). In this trial, 45% of ACZ885-treated patients who were prescribed corticosteroids at study entry were able to substantially reduce their use of steroids, and one third of patients completely discontinued steroids. Additionally, ACZ885-treated patients were nearly three times less likely to experience a new flare, with 74% of ACZ885-treated patients remaining flare-free compared to 25% with placebo (P=0.003) (Kaplan-Meier estimate).
Marketed as Ilaris, canakinumab is approved for the treatment of Cryopyrin-Associated Periodic Syndromes in adults and children ≥4yrs of age, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome.
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