Citation:
Nicolino Ruperto, Brunner, Hermine I, Quartier, Pierre , Constantin, Tamás , Wulffraat, Nico , Horneff, Gerd , Brik, Riva , McCann, Liza , Kasapcopur, Ozgur , Rutkowska-Sak, Lidia , Schneider, Rayfel , Berkun, Yackov , Calvo, Inmaculada , Erguven, Muferet , Goffin, Laurence , Hofer, Michael , Kallinich, Tilmann , Oliveira, Sheila K, Uziel, Yosef , and Viola, Stefania . 2012.
“Two Randomized Trials Of Canakinumab In Systemic Juvenile Idiopathic Arthritis.”. New England Journal Of Medicine, 367, Pp. 2396 - 2406.
http://search.ebscohost.com/login.aspx?direct=true&db=aph&AN=84515344&site=eds-live.
Abstract:
Background: Interleukin-1 is pivotal in the pathogenesis of systemic juvenile idiopathic arthritis (JIA). We assessed the efficacy and safety of canakinumab, a selective, fully human, anti–interleukin-1β monoclonal antibody, in two trials. Methods: In trial 1, we randomly assigned patients, 2 to 19 years of age, with systemic JIA and active systemic features (fever; >=2 active joints; C-reactive protein, >30 mg per liter; and glucocorticoid dose, <=1.0 mg per kilogram of body weight per day), in a double-blind fashion, to a single subcutaneous dose of canakinumab (4 mg per kilogram) or placebo. The primary outcome, termed adapted JIA ACR 30 response, was defined as improvement of 30% or more in at least three of the six core criteria for JIA, worsening of more than 30% in no more than one of the criteria, and resolution of fever. In trial 2, after 32 weeks of open-label treatment with canakinumab, patients who had a response and underwent glucocorticoid tapering were randomly assigned t