Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: Results from the 5-year long-term extension of the phase III pivotal trials

Nicolino Ruperto*, Hermine I. Brunner, Pierre Quartier, Tamàs Constantin, Nico M. Wulffraat, Gerd Horneff, Ozgur Kasapcopur, Rayfel Schneider, Jordi Anton, Judith Barash, Reinhard Berner, Fabrizia Corona, Ruben Cuttica, Marine Fouillet-Desjonqueres, Michel Fischbach, Helen E. Foster, Dirk Foell, Sebastião C. Radominski, Athimalaipet V. Ramanan, Ralf TrauzeddelErbil Unsal, Jérémy Levy, Eleni Vritzali, Alberto Martini, Daniel J. Lovell

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

22 Citations (Scopus)
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Abstract

Objectives: To evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA). Methods: Patients (2-19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CRACR). Efficacy analyses are reported as per the intent-to-treat population. Results: 144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CRACR was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years. Efficacy results were maintained up to 5 years. Of the 128/177 (72.3%) patients on glucocorticoids, 20 (15.6%) discontinued and 28 (22%) tapered to 0.150 mg/kg/day. Seven patients discontinued canakinumab due to CR. There were 13 macrophage activation syndrome (three previously reported) and no additional deaths (three previously reported). No new safety findings were observed. Conclusion: Response to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab. Trial registration numbers: NCT00886769, NCT00889863, NCT00426218 and NCT00891046.

Original languageEnglish
Article numbere213150
Number of pages10
JournalAnnals of the Rheumatic Diseases
Volume77
Issue number12
Early online date29 Sep 2018
DOIs
Publication statusPublished - Dec 2018

Keywords

  • canakinumab
  • clinical trial
  • interleukin-1β
  • long-term extension
  • systemic juvenile idiopathic arthritis.

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