title: A safety evaluation of canakinumab for the treatment of systemic onset juvenile idiopathic arthritis.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a Department of Pediatrics, Section Pediatric Rheumatology , Wilhelmina Children's Hospital, University Medical Centrum Utrecht , Utrecht , The Netherlands.
authors.forename: Nico M
authors.initials: NM
authors.lastname: Wulffraat
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D002986:Clinical Trials as Topic; D006801:Humans; D007375:Interleukin-1 / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007375:Interleukin-1; C541220:canakinumab
keywords: IL-1 family; auto-inflammatory syndromes; inflammasome; registry; safety; systemic onset juvenile idiopathic arthritis