Long-term efficacy and safety of adalimumab in 4-12 year old patients with juvenile idiopathic arthritis

نویسندگان

  • N Ruperto
  • DJ Lovell
  • A Reiff
  • M Gamir
  • G Higgins
  • I Koné-Paut
  • OY Jones
  • E Chalom
  • N Ilowite
  • C Wouters
  • MJ McIlraith
  • S Liu
  • H Kupper
  • EH Giannini
  • A Martini
چکیده

Methods Patients with polyarticular course JIA (N=171) were enrolled in a phase 3, randomized-withdrawal, doubleblind (DB), stratified, parallel-group study, which consisted of a 16-wk open-label (OL) lead-in, a 32-wk DB phase, and an up to 5 year OL extension phase that included BSA dosing prior to a switch to fixed dose (FD). Patients on ADA (24 mg/m; max dose, 40 mg) were evaluated based on ACR pediatric response criteria for improvement (ACR Pedi 30/50/70/90) and monitored for adverse events (AEs).

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عنوان ژورنال:

دوره 9  شماره 

صفحات  -

تاریخ انتشار 2011