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European Commission approves Ilaris for SJIA treatment
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The European Commission has approved canakinumab for treating active systemic juvenile idiopathic arthritis in patients aged 2 years and older who experience inadequate response to nonsteroidal anti-inflammatory drugs and systemic corticosteroids, Novartis announced.
Canakinumab (Ilaris) is a selective, fully human, monoclonal antibody that inhibits IL-1 beta, according to a press release. It was approved as monotherapy or as combination therapy with methotrexate based on the results of two phase 3 trials on patients, aged 2 to 19 years, with systemic juvenile idiopathic arthritis (SJIA).
The first trial was a 4-week, double blind study, in which 43 patients were randomly treated with a single subcutaneous dose of canakinumab (4 mg/kg, up to 300 mg) while 41 patients received placebo. Eighty-four percent of treated patients met the primary endpoint at day 15 of achieving the adapted pediatric American College of Rheumatology 30% response and fever resolution from baseline, compared with 10% of placebo patients.
The second trial studied 177 patients with SJIA and was divided into two parts. Part 1 was an open-label, single-arm study in which patients received canakinumab (4 mg/kg, up to 300 mg) every 4 weeks. Sixty-two percent of patients who attempted tapering substantially reduced their corticosteroid use, far exceeding the primary endpoint of at least 25% of patients achieving tapering while receiving canakinumab. Forty-six percent discontinued corticosteroid use, according to the release.
In part 2, patients were randomly assigned to continue canakinumab therapy or placebo every 4 weeks, until a pre-specified number of flare-events occurred (n=37). Patients treated with canakinumab had a 64% relative reduction in flare risk compared with placebo patients (HR=0.36; 95% CI, 0.17-0.75).
“The EU approval of Ilaris provides patients suffering from SJIA with a convenient new treatment option offering a favorable benefit risk-profile, administered as a single monthly subcutaneous injection,” Timothy Wright, MD, global head of development, Novartis Pharmaceuticals, said in the release.