By Crina Frincu-Mallos, PhD
WASHINGTON, DC -- October 19, 2009 -- Canakinumab appears to be safe and efficacious in children with systemic juvenile idiopathic arthritis (sJIA), according to preliminary results of a study presented here at the 2009 American Academy of Pediatrics (AAP) National Conference & Exhibition.
Nicolino Ruperto, MD, Paediatric Rheumatology International Trials Organisation (PRINTO), IRCCS G. Gaslini, Genova, Italy, reported the data here on October 18.
The multicentre, open-label, dose-escalation, phase 2 study aimed to evaluate the safety, pharmacokinetics, and efficacy of canakinumab in 23 paediatric patients, aged 4 to 19 years, with active sJIA.
Patients were initially administered a single dose of subcutaneous canakinumab 0.5 to 9 mg/kg. Upon relapse, they received additional doses of canakinumab.
Canakinumab was well tolerated, with most frequent adverse events (AEs) being infections and gastrointestinal disorders. "Two patients experienced serious AEs related to canakinumab," said Dr. Ruperto, adding that the serious AEs resolved during treatment.
Out of the 22 evaluable patients, 13 (59%) responded to canakinumab and achieved American College of Rheumatology (ACR) ped50 or better at day 15, noted Dr. Ruperto, adding that there were 4 cases (18%) of complete response to therapy.
"The best baseline parameter to predict response was the number of active joints," he said in his poster presentation, noting that in the first 22 patients on study there was a median of 33.5 active joints for nonresponders versus 9 for responders.
Depending on the dose of canakinumab administered (<3 mg/kg, 3 mg/kg, or >3 mg/kg) the median time to relapse was 56 days (95% confidence interval [CI], 32-100), 60 days (95% CI, 38-95), and 90 days (95% CI, 45-181), respectively.
Additionally, Dr. Ruperto and colleagues noted that the probability of relapse after 1 month of treatment was dose-dependent as well: 19% at doses <3 mg/kg, 17% at 3 mg/kg, and 7% at doses higher than 3 mg/kg.
Based on these interim results of the ongoing study, Dr. Ruperto and colleagues concluded that canakinumab was well tolerated and has an encouraging efficacy profile in this patient population, with 59% of patients rapidly achieving ACRped50, steroid tapering in the majority of responders, and inactive disease in 18% of treated patients.
Funding for this study was provided by Novartis Institutes for Biomedical Research.
[Presentation title: Phase II Trial With Canakinumab (ACZ885) to Evaluate Safety and Preliminary Efficacy in Children With Systemic Juvenile Idiopathic Arthritis (sJIA). Abstract 6965]
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