EU approval for Ilaris for SJIA

Novartis announced that the European Commission (EC) has approved the use of Ilaris (canakinumab) in the treatment of active Systemic Juvenile Idiopathic Athritis (SJIA) in patients aged 2 years and older, who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.

SJIA is a rare and disabling form of childhood arthritis with limited treatment options. The condition is characterized by spiking fever, rash and arthritis that can affect children as young as 2 years old and can continue into adulthood. Ilaris can be given as monotherapy or in combination with methotrexate.

This approval was based on two Phase III trials in SJIA patients, aged 2-19, which showed significant improvement in the majority of Ilaris-treated patients. Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted paediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15. In the open-label part of Study 2, 92 of 128 patients attempted "corticosteroid tapering". Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the Ilaris group as compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75).Data from a pooled efficacy analysis showed that after 12 weeks of Ilaris treatment 61% of patients reached an adapted paediatric ACR70 and 28% of patients had inactive disease].