Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis

Nicolino Ruperto, Hermine I. Brunner, Pierre Quartier, Tamás Constantin, Nico Wulffraat, Gerd Horneff, Riva Brik, Liza McCann, Ozgur Kasapcopur, Lidia Rutkowska-Sak, Rayfel Schneider, Yackov Berkun, Inmaculada Calvo, Muferet Erguven, Laurence Goffin, Michael Hofer, Tilmann Kallinich, Sheila K. Oliveira, Yosef Uziel, Stefania ViolaKiran Nistala, Carine Wouters, Rolando Cimaz, Manuel A. Ferrandiz, Berit Flato, Maria Luz Gamir, Isabelle Kone-Paut, Alexei Grom, Bo Magnusson, Seza Ozen, Flavio Sztajnbok, Karine Lheritier, Ken Abrams, Dennis Kim, Alberto Martini, Daniel J. Lovell

Research output: Contribution to journalArticle

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 to continued treatment with canakinumab or to placebo. The primary outcome was time to flare of systemic JIA. RESULTS: At day 15 in trial 1, more patients in the canakinumab group had an adapted JIA ACR 30 response (36 of 43 [84%], vs. 4 of 41 [10%] in the placebo group; P

Original languageEnglish
Pages (from-to)2396-2406
Number of pages11
JournalNew England Journal of Medicine
Volume367
Issue number25
DOIs
Publication statusPublished - Dec 20 2012

ASJC Scopus subject areas

  • Medicine(all)

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    Ruperto, N., Brunner, H. I., Quartier, P., Constantin, T., Wulffraat, N., Horneff, G., Brik, R., McCann, L., Kasapcopur, O., Rutkowska-Sak, L., Schneider, R., Berkun, Y., Calvo, I., Erguven, M., Goffin, L., Hofer, M., Kallinich, T., Oliveira, S. K., Uziel, Y., ... Lovell, D. J. (2012). Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. New England Journal of Medicine, 367(25), 2396-2406. https://doi.org/10.1056/NEJMoa1205099