Whereas we mostly tend to think of arthritis as an old person’s disease, there is a form of it that affects children—and those kids now have a reason to jump for joy. The FDA just approved Novartis’ Ilaris® (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older. Ilaris is, according to Novartis, the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and is reportedly the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.
This approval was based on two Phase III trials in SJIA patients, aged 2–19, showing 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.
“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,” said Daniel Lovell, M.D., study investigator and Joseph E. Levinson professor of pediatrics at the Cincinnati Children’s Hospital Medical Center. “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.”
In addition to SJIA, Ilaris was also been approved by the FDA back in June of 2009 for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS). That makes this the second Ilaris indication for patients with rare autoinflammatory conditions. “We are committed to studying Ilaris in other IL-1 beta-mediated inflammatory diseases, including several rare diseases for which treatment options do not currently exist,” added Timothy Wright, M.D., global head of development at Novartis Pharmaceuticals.