Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris(canakinumab) for the treatment of active systemic juvenile idiopathic
arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first
interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only
treatment approved specifically for SJIA that is given as a
once-monthly subcutaneous injection. SJIA is a rare and
disabling form of childhood arthritis characterized by spiking fever,
rash and arthritis that can affect children as young as 2 years old and
can continue into adulthood
This approval was based on two Phase III trials in SJIA patients, aged
2–19, showing 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 pediatric 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
Source: Novartis
