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Drug Safety Evaluation

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

Pages 1961-1967 | Published online: 14 Nov 2015
 

Abstract

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.

Additional information

Notes on contributors

Nico M Wulffraat

Affiliation

Nico M Wulffraat

Department of Pediatrics, Section Pediatric Rheumatology, Wilhelmina Children’s Hospital, University Medical Centrum Utrecht, Suite KC 03.063, Utrecht, 3508AB, The Netherlands

Tel: +31 887 554 003

Fax: +31 887 555 350

E-mail: [email protected]

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