A safety evaluation of canakinumab for the treatment of systemic onset juvenile idiopathic arthritis.

INTRODUCTION: Interleukin-1 (IL-1) is the key molecule of a strong pro-inflammatory pathway in the innate immune system. The IL-1 family harbors components with pro- and anti-inflammatory effects essential for the regulation of the inflammation process. Auto-inflammatory diseases and systemic onset juvenile idiopathic arthritis (JIA) are examples of chronic inflammatory diseases that are IL-1 dependent. IL-1 blockade has proven to be very effective and has greatly improved the outcome of these disorders. AREAS COVERED: This review describes the components of the IL-1 family and the available IL-1 blocking agents for clinical practice. Among them, canakinumab was more recently introduced. Based on the published clinical trials one can conclude that the clinical efficacy in auto-inflammatory diseases is at least as good as other IL-1 blocking agents. The safety data are limited to those registration studies (Phase 2 and 3). In short term the adverse events described are not very different from the other IL-1 blockers. EXPERT OPINION: Longer term use in larger numbers of patients and adequate data collection using large-scale registries are necessary to provide us with a well-balanced overview of safety issues of canakinumab. Registration studies and open label extension studies show an acceptable safety profile so far.