On May 10, 2013, the U.S. Food and Drug Administration (FDA) approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years and older. Ilaris, a fully human monoclonal antibody developed by Novartis, is the first interleukin-1 (IL-1) beta inhibitor approved for systemic juvenile idiopathic arthritis and the only treatment approved specifically for the disease that is administerd as a once-monthly subcutaneous injection. Systemic juvenile idiopathic arthritis, which is considered the most severe form of juvenile arthritis, affects 5-15 children per 100,000 in the United States.
The FDA approval was based on two Phase III trials. Results from the first study showed that, by day 15, 84% of study participants treated with one subcutaneous dose of Ilaris achieved the primary endpoint of ACR 30 (30% improvement in symptoms as defined by the American College of Rheumatology) compared to 10% of participants receiving placebo. In the second study, 92 of 128 patients attempted corticosteroid tapering; 62% substantially reduced their use of corticosteroids while 46% were able to discontinue corticosteroids. Ilaris also reduced the recurrence of flares in the second study.
- Children Can Develop Juvenile Arthritis
- 2011 ACR Recommendations for the Treatment of Juvenile Idiopathic Arthritis
- Juvenile Arthritis Screening Quiz
Photo by Sheryl Griffin (iStockphoto)