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Arthritis and Arthritic Pain (Pediatric)

January 7, 2013

Novartis published results of a phase III trial of ACZ885 (canakinumab) for the treatment of systemic juvenile idiopathic arthritis (SJIA). This four-week, randomized, double-blind, placebo-controlled study, Beta-SPECIFIC 1, enrolled 84 patients between ages two and 19 with active SJIA. Subjects received a single subcutaneous dose of 4mg/kg (up to 300mg) ACZ885 or placebo. Data demonstrated 84% of 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). 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). The drug was well tolerated. Based on these data, Novartis pursued regulatory submission in the U.S. and Europe.

April 23, 2012

UCB Pharma reported results from a phase III trial of certolizumab pegol for axial spondyloarthritis (AxSpA). This 24-week, multicenter, double-blind, placebo-controlled trial enrolled 325 subjects with AxSpA who were randomized to receive certolizumab pegol at 200 mg every two weeks, 400 mg every four weeks, or placebo. The primary endpoint was at least 20% change in the Assessment of SpondyloArthritis international Society improvement criteria (ASAS20). At week 12 a statistically significant higher proportion of subjects in the certolizumab pegol arm reached this endpoint compared to those in the placebo arm. Sub-population analyses indicated that certolizumab pegol also improved the signs and symptoms of AS and non-radiographic AxSpA. The most frequent adverse events were upper respiratory tract infection, elevated liver function tests and abnormal CPK levels.

September 26, 2011

Novartis released results from a phase III trial of canakinumab for systemic juvenile idiopathic arthritis. This randomized, double-blind, placebo-controlled study enrolled 84 subjects between the ages of 2 and 19 years who received either a single subcutaneous dose of canakinumab (4 mg/kg, up to 300 mg) or placebo for four weeks. The primary endpoint was the proportion of subjects achieving the adapted ACR Pediatric 30 criteria, demonstrating a 30% improvement in at least three of the six variables, from baseline at Day 15. In the canakinumab treatment arm 83.7% of subjects experienced at least a 30% improvement in symptoms versus 9.8% for placebo (p<0.0001), and 32.6% achieved a 100% improvement versus 0% for placebo (p≡0.0001).

November 3, 2008

Novartis reported positive results from two clinical trials of canakinumab for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) and Systemic Juvenile Idiopathic Arthritis (SJIA). The CAPS study was a six month trial in subjects aged nine to 74 years old and was divided into three parts. In the first part, lasting two months, 35 subjects received a single dose of canakinumab by subcutaneous injection. All but one subject showed a rapid and long-lasting clinical and biochemical response. Part two was a randomized six-month, double-blind, placebo-controlled withdrawal design study in 31 subjects who maintained their response. The subjects were treated with canakinumab or placebo every two months. This portion of the study included the primary endpoint, a comparison between the number of subjects treated with canakinumab who experienced disease outbreaks versus those on placebo. Results showed that no subjects in the canakinumab group experienced a disease flare compared to 81% in the placebo group (p<0.001). Markers of inflammation (C-reactive protein and serum amyloid A) were normalized in patients treated with canakinumab, but increased significantly for those on placebo. Part three of the study is underway in subjects who had relapsed. The SJIA study was an open label, repeat dose trial in 26 pediatric subjects with active SJIA. Results showed substantial clinical improvement (measured by the pediatric ACR50 scale) was reached within 15 days. In addition, four subjects achieved complete remission of the disease. Based on the results Novartis plans to continue with the development of canakinumab