FDA approves Ilaris to treat systemic juvenile idiopathic arthritis

The FDA has approved Ilaris to treat patients aged 2 years or older with active systemic juvenile idiopathic arthritis, Novartis announced today.

Ilaris (canakinumab) is the first interleukin-1 beta inhibitor approved for treating systemic juvenile idiopathic arthritis (SJIA) and “the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection,” according to a company press release.

The approval was based on two phase 3 studies that included patients with SJIA, aged 2 to 19 years. In the first study, 84% of 43 patients treated with a single subcutaneous dose of Ilaris (4 mg/kg, up to 300 mg) achieved primary endpoint of the adapted ACR30 response criteria at day 15, compared with 10% of 41 patients assigned placebo.

In the open-label portion of the two-part second trial, 92 of 128 patients who had received a subcutaneous dose of Ilaris (4 mg/kg, up to 300 mg) tried corticosteroid tapering, with 62% of patients able to substantially reduce usage and 46% discontinuing corticosteroids. In the second part, patients randomly were assigned to either continue receiving Ilaris or placebo every 4 weeks, with a 64% relative reduction in flare risk for patients in the Ilaris group compared with placebo patients (HR=0.36; 95% CI, 0.17-0.75).

“The efficacy of Ilaris, along with its monthly subcutaneous dosing, make it an exciting new option for children who are living with this debilitating disease,” investigator Daniel Lovell, MD, MPH, the Joseph E. Levinson professor of pediatrics, Cincinnati Children’s Hospital Medical Center, said in the release. “Additionally, the potential to reduce corticosteroid use is particularly beneficial in this patient population given the side effects associated with long-term use of corticosteroids in children.”