FDA Has Approved Il-1 Inhibitor Canakinumab for Systemic JIA

Novartis today announced that the FDA has approved canakinumab (Ilaris) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. The interleukin-1 beta (IL-1 beta) inhibitor is administered as a once-monthly subcutaneous injection.

The approval was based on results of two Phase III studies both of which met their main endpoints. In an 84-patient randomized trial, 84% of patients treated with canakinumab met the goal of an adapted pediatric ACR30 score at day 15, compared to 10% of placebo-treated subjects. The second study, an 177-patient trial, found that 62% of 92 patients who attempted corticosteroid tapering were successful, and 46% discontinued them completely. There was also a 64% reduction in the risk of flare compared to the placebo group.

Canakinumab joins the IV-administered interleukin-6 inhibitor tocilizumab (Actemra) as approved for treatment of SJIA. Although there are no head-to-head trials, the studies assessing the two drugs have been carried out collaboratively by two multicenter consortia using similar protocols. In an article published here last fall (New Drug Options for Systemic JIA: Realities and Open Questions), the lead investigator of the canakinumab trials, Daniel Lovell MD MPH of Cincinnati Children's Hospital, compared the two treatments and discussed their impact on management of SJIA.