Novartis has announced positive results from the first pivotal Phase III trial of ACZ885 (canakinumab) in patients with systemic juvenile idiopathic arthritis (SJIA).
The results, presented at the 2011 European Pediatric Rheumatology Congress in Bruges, Belgium, showed all primary and secondary endpoints of the study were met.
Most ACZ885 patients (83.7%) experienced at least a 30% improvement in symptoms vs. 9.8% for placebo (p<0.0001) and a third of ACZ885 patients (32.6%) achieved a 100% improvement vs. 0% for placebo (p=0.0001).
ACZ885 is an investigational, fully human monoclonal antibody that neutralizes interleukin-1 beta (IL-1 beta).
“These data suggest that ACZ885 could become an important treatment option for children living with SJIA, the most difficult-to-treat and severe form of juvenile arthritis, potentially transforming their lives,” said Professor Pierre Quartier, MD, Pediatric Rheumatologist at Necker-Enfants Malades Hospital in Paris, France.
“ACZ885 provided rapid and long-lasting symptom relief by targeting interleukin-1 beta, a key inflammatory mediator of the disease.”
In the study, patients were measured according to the adapted American College of Rheumatology (ACR) Pediatric criteria, which includes absence of fever.
The results of a second pivotal Phase III trial, aimed at determining whether ACZ885 can extend the time to next flare and reduce or eliminate corticosteroid use, will be presented later this year. Worldwide regulatory submissions for ACZ885 in SJIA are planned for 2012.