Results of Phase III studies show substantial benefits of ACZ 885 (Novartis) in patients with Juvenile Idiopathic Arthritis

Results of two Phase III trials show ACZ 885 (canakinumab), from Novartis, provided substantial symptom relief in young patients with systemic Juvenile Idiopathic Arthritis (SJIA). In addition, ACZ 885 delayed disease flare recurrence and allowed patients to substantially reduce or discontinue use of corticosteroids.

In beta-SPECIFIC 1 (trial-1), 84% of SJIA patients treated with ACZ 885 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). in beta-specific 2 (trial-2), 45% of acz 885-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, acz 885-treated patients were nearly three times less likely to experience a new flare, with 74% of acz 885-treated patients remaining flare-free compared to 25% with placebo (p="0.003).">

Data from the Phase III program of ACZ 885 in SJIA form the basis for worldwide regulatory submissions. In the EU, regulatory submission was completed in November 2012. US regulatory submission is also on track. Data were published in the NEJM. See: "Canakinumab in Systemic Juvenile Idiopathic Arthritis: 2 randomized trials." Ruperto N, Brunner H, Quartier P, et al. N Engl J Med 2012; e-pub ahead of print.