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Long-Term Efficacy of Canakinumab in Systemic Juvenile Idiopathic Arthritis

Oct 01, 2018 3:35 pm

Only inhibitors of IL-1 (canakinumab) and IL-6 (tocilizumab) are FDA approved for use in children with systemic onset juvenile idiopathic arthritis (sJIA). Now, long-term data from the extension studies from two phase III studies shows that canakinumab yields long-term improvements with reduced glucocorticoid dosing with no new safety findings with long-term use. 

Nearly 80% of the 177 patients enrolled in the core study entered the open label extension, and of these, 75 patients (42%) completed the 5-year study.  The remaining 102 (58%) discontinued mainly for inefficacy. 

Discontinuation rates noted were higher in late responders (81%) compared with early responders (29%) to canakinumab.

At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively.

Clinical remission was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years.

A total of 128/177 (72.3%) patients were on glucocorticoids at entry and 15.6% discontinued and 22% tapered steroids to 0.150 mg/kg/day.

Overall the safety profile of canakinumab remained unchanged.  Serious adverse events included flares of sJIA (25 events or 5.24/100 patient-years) and 13 patients with macrophage activation syndrome (17 events or 3.56/100 patient-years) and there were no new deaths.

One limitation of this study may be the number of dropouts - with 58% of the patients discontinuing canakinumab over the 5 years. This may be explained by the very long duration of the LTE and the fact that some patients with sJIA will spontaneously remit. 

 

Disclosures
The author has received compensation as an advisor or consultant on this subject

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