The US Food and Drug Administration (FDA) approved canakinumab (Ilaris; Novartis) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged ≥2 years.
Ilaris is the first interleukin-1 beta inhibitor approved for the treatment of SJIA, and is the only agent approved for SJIA that is administered as a once-monthly subcutaneous injection.
“The efficacy of Ilaris, along with its monthly subcutaneous dosing, makes it an exciting new option for children who are living with this debilitating disease,” said Daniel Lovell, MD, MPH, the Joseph E. Levinson Professor of Pediatrics at the Cincinnati Children’s Hospital Medical Center and study investigator.
The FDA’s approval of Ilaris was based on 2 pivotal phase 3 clinical trials in patients with SJIA (aged 2-19 years) that showed significant improvement in the majority of patients who received canakinumab. In the 4-week, double-blind, placebo-controlled study, 84% of the patients who were randomized to canakinumab achieved the primary end point of ≥30% improvement (ie, adapted pediatric American College of Rheumatology 30% response criteria [ACR30]) at day 15 compared with only 10% of the patients who received placebo.
The second study investigated the use of corticosteroids in patients receiving canakinumab. Of the 128 patients who received canakinumab 4 mg/kg up to 300 mg every 4 weeks, 62% had their corticosteroid dose tapered substantially, and 46% were able to completely discontinue the use of corticosteroids.
The most serious side effects associated with canakinumab in the treatment of SJIA are cold symptoms, upper respiratory tract infection, pneumonia, runny nose, sore throat, urinary tract infection, gastroenteritis, stomach pain, and injection site reactions.
Ilaris is already approved for the treatment of cryopyrin-associated periodic syndromes, a rare debilitating genetic disorder, in more than 60 countries, including the European Union, the United States, Switzerland, and Japan. (May 10, 2013)