Canakinumab (ACZ885; Novartis) achieves major relief of symptoms in patients with systemic juvenile idiopathic arthritis (SJIA), according to encouraging results from a pivotal phase III trial with the anti-interleukin-1 beta antibody reported at the Pediatric Rheumatology European Society Congress (14-18 September, Bruges, Belgium).

The study randomised 84 patients with active SJIA (age 2-19 years) to a single subcutaneous dose of canakinumab (4mg/kg) or placebo. Most of the children treated with the antibody (83.7%) showed at least a 30% improvement in symptoms (ACR Ped30) compared to only 9.8% of those given placebo (p

Canakinumab was generally well tolerated. Adverse events were reported in 55.8% of children treatment with canakinumab and 39.0% of the placebo group. There were no discontinuations due to adverse events in either treatment group.

“These data suggest that canakinumab could become an important treatment option for children with SJIA, which is most difficult to treat and severe form of juvenile arthritis,” suggested Pierre Quartier, co-investigator and paediatric rheumatologist at Necker-Enfants Malades Hospital, Paris, France. Children treated with the antibody showed complete control of fever, a major improvement in functional scores and ability to carry out daily activities, and had fewer inflamed joints, he noted.

Professor Quartier said that currently available treatments for SJIA only partially mitigate symptoms and do not prevent long-term damage associated with the condition, adding that prolonged use of steroids can cause slowed growth and delayed puberty.

Canakinumab is a long acting fully human anti-interleukin-1-beta antibody. It inhibits the effects of the cytokine, which plays a major role in several inflammatory conditions including SJIA. A second phase III trial is investigating whether the antibody can extend the time between disease flares and reduce or eliminate corticosteroid use in SJIA. Novartis is planning worldwide regulatory submissions in SJIA for 2012.

Written by Susan Mayor
Susan Mayor PhD, medical journalist, London, UK